Food Supplement Program’s Medical Deduction

Helping Seniors and People with Disabilities Get the Food they Need to Stay Healthy

Congress created the Food Supplement Program (formerly known as “Food Stamps”) to help Americans with limited income get the food they need to stay healthy.

Seniors and people with disabilities often need special diets, but medical expenses make it hard for them to buy the food they need. That is why Congress created a special “medical deduction” in the Food Supplement Program (FSP).

Who can get a FSP medical deduction?

If you are a “senior” or have a “disability” you may get a medical deduction. This means the more medical costs you have, the more FSP benefits you will get.

A “senior” is any person 60 years old or older.

A “person with a disability” is anyone who:

• Gets Supplemental Security Income (SSI) or Social Security Disability (SSDI); or any other federal, state or local public disability pension;
• Gets a State SSI supplement check;
• Gets MaineCare based on disability;
• Gets Railroad Retirement Disability benefits;
• Is a veteran who is totally disabled, permanently housebound, or needs aid and attendance; OR
• Is a surviving spouse of a veteran who is getting VA benefits or is a child of a veteran who is permanently disabled.
• How much is allowed for a “medical deduction”?

You can only count medical costs that are more than $35 a month. For example, if you and your spouse are both seniors and have total medical costs of $100 a month, your household’s medical deduction is $65 in that month.

There is no limit on the medical deduction. You can deduct all allowable medical costs over $35 even if you haven’t paid them yet.

IMPORTANT NOTE: Medical costs that will be paid by a health insurer or someone outside of your household cannot count as a medical deduction.

How do I claim my medical expenses?

• You can claim medical expenses when you apply for or recertify for the FSP. You can also ask your case worker at any time to give you a medical deduction.
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• You must show proof of your medical expenses. “Proof” can be receipts, cancelled checks, a print out from your pharmacy, your own written record of medically-related transportation, or other similar records and statements.
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• You do not need to give proof of your medical expenses each month. You can ask your worker to estimate your expenses over your FSP certification period if you don’t expect them to change.
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• What expenses count towards a medical deduction?
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• Click here to get a checklist of medical expenses that count toward your medical deduction. This will help you identify your expenses. You can fill this out and give it to your FSP caseworker with proof of your expenses.

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Tips for Dietary Supplement Users

Making Informed Decisions and Evaluating Information

FDA, as well as health professionals and their organizations, receive many inquiries each year from consumers seeking health-related information, especially about dietary supplements. Clearly, people choosing to supplement their diets with herbals, vitamins, minerals, or other substances want to know more about the products they choose so that they can make informed decisions about them. The choice to use a dietary supplement can be a wise decision that provides health benefits. However, under certain circumstances, these products may be unnecessary for good health or they may even create unexpected risks.
Before taking a dietary supplement…

• 5 Things to Consider Before Taking a Dietary Supplement(PDF:  49 KB)
• Given the abundance and conflicting nature of information now available about dietary supplements, you may need help to sort the reliable information from the questionable. Below are tips and resources that we hope will help you be a savvy dietary supplement user. The principles underlying these tips are similar to those principles a savvy consumer would use for any product.
• Basic Points to Consider 
• Tips on Searching the Web for Information on Dietary Supplements
• More Tips and To-Do's 
• Note: Links to non-Federal government organizations found on this site are provided solely as a service to consumers and do not represent an FDA endorsement of these organizations or their products. (For resources see Selected References.)
• Basic Points to Consider

Do I need to think about my total diet? 

Yes. Dietary supplements are intended to supplement the diets of some people, but not to replace the balance of the variety of foods important to a healthy diet. While you need enough nutrients, too much of some nutrients can cause problems. You can find information on the functions and potential benefits of vitamins and minerals, as well as upper safe limits for nutrients at the National Academy of Sciences Web site disclaimer icon. 

Should I check with my doctor or healthcare provider before using a supplement?
This is a good idea, especially for certain population groups. Dietary supplements may not be risk-free under certain circumstances. If you are pregnant, nursing a baby, or have a chronic medical condition, such as, diabetes, hypertension or heart disease, be sure to consult your doctor or pharmacist before purchasing or taking any supplement. While vitamin and mineral supplements are widely used and generally considered safe for children, you may wish to check with your doctor or pharmacist before giving these or any other dietary supplements to your child. If you plan to use a dietary supplement in place of drugs or in combination with any drug, tell your health care provider first. Many supplements contain active ingredients that have strong biological effects and their safety is not always assured in all users. If you have certain health conditions and take these products, you may be placing yourself at risk.

Some supplements may interact with prescription and over-the-counter medicines.
Taking a combination of supplements or using these products together with medications (whether prescription or OTC drugs) could under certain circumstances produce adverse effects, some of which could be life-threatening. Be alert to advisories about these products, whether taken alone or in combination. For example: Coumadin (a prescription medicine), ginkgo biloba (an herbal supplement), aspirin (an OTC drug) and vitamin E (a vitamin supplement) can each thin the blood, and taking any of these products together can increase the potential for internal bleeding. Combining St. John's Wort with certain HIV drugs significantly reduces their effectiveness. St. John's Wort may also reduce the effectiveness of prescription drugs for heart disease, depression, seizures, certain cancers or oral contraceptives.

Some supplements can have unwanted effects during surgery: 
It is important to fully inform your doctor about the vitamins, minerals, herbals or any other supplements you are taking, especially before elective surgery. You may be asked to stop taking these products at least 2-3 weeks ahead of the procedure to avoid potentially dangerous supplement/drug interactions -- such as changes in heart rate, blood pressure and increased bleeding - that could adversely affect the outcome of your surgery.

Adverse effects from the use of dietary supplements should be reported to MedWatch: 
You, your health care provider, or anyone may  directly to FDA if you believe it is related to the use of any dietary supplement product, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or reporting report a serious adverse event or illness on-line. FDA would like to know whenever you think a product caused you a serious problem, even if you are not sure that the product was the cause, and even if you do not visit a doctor or clinic. In addition to communicating with FDA on-line or by phone, you may use the MedWatch form available from the FDA Web site. 

Who is responsible for ensuring the safety and efficacy of dietary supplements?
Under the law, manufacturers of dietary supplements are responsible for making sure their products are safe before they go to market. They are also responsible for determining that the claims on their labels are accurate and truthful. Dietary supplement products are not reviewed by the government before they are marketed, but FDA has the responsibility to take action against any unsafe dietary supplement product that reaches the market. If FDA can prove that claims on marketed dietary supplement products are false and misleading, the agency may take action also against products with such claims.

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Tips on Searching the Web for Information on Dietary Supplements

When searching on the Web, try using directory sites of respected organizations, rather than doing blind searches with a search engine. Ask yourself the following questions:
Who operates the site?
Is the site run by the government, a university, or a reputable medical or health-related association (e.g., American Medical Association, American Diabetes Association, American Heart Association, National Institutes of Health, National Academies of Science, or U.S. Food and Drug Administration)? Is the information written or reviewed by qualified health professionals, experts in the field, academia, government or the medical community? 

What is the purpose of the site?
Is the purpose of the site to objectively educate the public or just to sell a product? Be aware of practitioners or organizations whose main interest is in marketing products, either directly or through sites with which they are linked. Commercial sites should clearly distinguish scientific information from advertisements. Most nonprofit and government sites contain no advertising; and access to the site and materials offered are usually free. 

What is the source of the information and does it have any references?
Has the study been reviewed by recognized scientific experts and published in reputable peer-reviewed scientific journals, like the New England Journal of Medicine? Does the information say "some studies show..." or does it state where the study is listed so that you can check the authenticity of the references? For example, can the study be found in the National Library of Medicine's database of literature citations (PubMed). 

Is the information current?

Check the date when the material was posted or updated. Often new research or other findings are not reflected in old material, e.g., side effects or interactions with other products or new evidence that might have changed earlier thinking. Ideally, health and medical sites should be updated frequently. 

How reliable is the Internet or e-mail solicitations?
While the Internet is a rich source of health information, it is also an easy vehicle for spreading myths, hoaxes and rumors about alleged news, studies, products or findings. To avoid falling prey to such hoaxes, be skeptical and watch out for overly emphatic language with UPPERCASE LETTERS and lots of exclamation points!!!! Beware of such phrases such as: "This is not a hoax" or "Send this to everyone you know."

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More Tips and To-Do's

Ask yourself: Does it sound too good to be true?
Do the claims for the product seem exaggerated or unrealistic? Are there simplistic conclusions being drawn from a complex study to sell a product? While the Web can be a valuable source of accurate, reliable information, it also has a wealth of misinformation that may not be obvious. Learn to distinguish hype from evidence-based science. Nonsensical lingo can sound very convincing. Also, be skeptical about anecdotal information from persons who have no formal training in nutrition or botanicals, or from personal testimonials (e.g. from store employees, friends, or online chat rooms and message boards) about incredible benefits or results obtained from using a product. Question these people on their training and knowledge in nutrition or medicine. 

Think twice about chasing the latest headline.
Sound health advice is generally based on a body of research, not a single study. Be wary of results claiming a "quick fix" that depart from previous research and scientific beliefs. Keep in mind science does not proceed by dramatic breakthroughs, but by taking many small steps, slowly building towards a consensus. Furthermore, news stories, about the latest scientific study, especially those on TV or radio, are often too brief to include important details that may apply to you or allow you to make an informed decision. 

Check your assumptions about the following:

#1 Questionable Assumption --
"Even if a product may not help me, it at least won't hurt me." It's best not to assume that this will always be true. When consumed in high enough amounts, for a long enough time, or in combination with certain other substances, all chemicals can be toxic, including nutrients, plant components, and other biologically active ingredients. 
#2 Questionable Assumption --
"When I see the term 'natural,' it means that a product is healthful and safe." Consumers can be misled if they assume this term assures wholesomeness, or that these food-like substances necessarily have milder effects, which makes them safer to use than drugs. The term "natural" on labels is not well defined and is sometimes used ambiguously to imply unsubstantiated benefits or safety. For example, many weight-loss products claim to be "natural" or "herbal" but this doesn't necessarily make them safe. Their ingredients may interact with drugs or may be dangerous for people with certain medical conditions.
#3 Questionable Assumption --
" A product is safe when there is no cautionary information on the product label." Dietary supplement manufacturers may not necessarily include warnings about potential adverse effects on the labels of their products. If consumers want to know about the safety of a specific dietary supplement, they should contact the manufacturer of that brand directly. It is the manufacturer's responsibility to determine that the supplement it produces or distributes is safe and that there is substantiated evidence that the label claims are truthful and not misleading.
#4 Questionable Assumption --
" A recall of a harmful product guarantees that all such harmful products will be immediately and completely removed from the marketplace." A product recall of a dietary supplement is voluntary and while many manufacturers do their best, a recall does not necessarily remove all harmful products from the marketplace.
Contact the manufacturer for more information about the specific product that you are purchasing. 
If you cannot tell whether the product you are purchasing meets the same standards as those used in the research studies you read about, check with the manufacturer or distributor. Ask to speak to someone who can address your questions, some of which may include:
What information does the firm have to substantiate the claims made for the product? Be aware that sometimes firms supply so-called "proof" of their claims by citing undocumented reports from satisfied consumers, or "internal" graphs and charts that could be mistaken for evidence-based research.
Does the firm have information to share about tests it has conducted on the safety or efficacy of the ingredients in the product?
Does the firm have a quality control system in place to determine if the product actually contains what is stated on the label and is free of contaminants?
Has the firm received any adverse events reports from consumers using their products?
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Selected References

THE FOLLOWING ARE SELECTED REFERENCES THAT MAY HELP USERS UNDERSTAND AND EVALUATE INFORMATION ENCOUNTERED ON THE INTERNET OR IN THE MARKETPLACE. (Links to non-Federal government organizations found on this site are provided as a service to our users and do not represent FDA endorsement of these organizations or their materials. FDA cannot monitor other sites to ensure that the information is the most current available.)
Evaluating Research

10 Things to Know About Evaluating Medical Resources on the Web disclaimer icon
A short guide developed by the National Cancer Institute, NIH, to help you evaluate medical Web sites. (July, 1999)

How to Understand and Interpret Food and Health-Related Scientific Studies disclaimer icon
This article provides an overview for understanding and interpreting food and health-related scientific studies (from the International Food Information Council, May 2000).

Making Sense of Health and Nutrition News disclaimer icon
Provides tips for evaluating science. (IFIC, Food Insight. Jan/Feb 2001) 

Navigating the Internet

Medical products and the Internet. A guide to finding reliable information disclaimer icon.
This document provides advice from the World Health Organization to help internet users obtain reliable, independent, and comparable information on the internet.

"Navigating for Health: Finding Accurate Information on the Internet" disclaimer icon.
(IFIC Food Insight article, November-December, 2000)

Quality of Health Information disclaimer icon.
Several links to other government and private sector web sites compiled by the Department of Health and Human Services' Healthfinder web site to help you evaluate online health information. 

Product Claims and Labeling

"Claims That Can Be Made for Conventional Foods and Dietary Supplements"
An FDA explanation of the various kinds of claims that can be made for foods and supplements. (Updated April, 2001.)

Questions You Can Ask About Health Claims. "Improving Public Understanding: Guidelines for Communicating Emerging Science on Nutrition, Food Safety and Health." disclaimer icon
These questions were developed to help journalists and scientists accurately convey health information. You can ask yourself these questions to help judge whether the information you are reading is fairly presented (the International Food Information Council, 1998)

"Miracle" Health Claims: Add a Dose of Skepticism disclaimer icon
This FDA/FTC joint agency information piece focuses on how to assess claims and seek advice, and avoid becoming a victim of health fraud. The information discusses how to minimize being cheated out of money, time, and health. (September 2001)

Advertising Dietary Supplements 

"Dietary Supplements: An Advertising Guide for Industry" disclaimer icon.
This document describes the factors that FTC takes into account in deciding whether an ad is truthful and not misleading. You can use them to judge the advertisements you see.
Other Sources

MedWatch.
FDA Safety Information and Adverse Event Reporting Program.

The Food and Nutrition Board disclaimer icon
The Food and Nutrition Board (FNB), National Academy of Sciences, as part of its mission, establishes principles and guidelines of adequate dietary intake. The FNB issues reports such as "Dietary Reference Intakes: Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline."

NUTRITION.GOV disclaimer icon
NUTRITION.GOV, a new federal resource, provides easy access to all online federal government information on nutrition, including dietary supplements.

MEDLINE Plus Health Information: Vitamin and Mineral Supplements disclaimer icon
MEDLINE Plus Health Information is a service of the National Library of Medicine, National Institutes of Health, that provides information on health topics, including vitamin and mineral supplements.

International Bibliographic Information on Dietary Supplements (IBIDS) disclaimer icon
The International Bibliographic Information on Dietary Supplements (IBIDS) NIH, Office of Dietary Supplements is a database of published, international, scientific literature on dietary supplements, including vitamins, minerals, and botanicals.

National Center for Complementary and Alternative Medicine disclaimer icon, NIH.
The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health disclaimer icon(NIH) is dedicated to exploring complementary and alternative healing practices in the context of rigorous science; training CAM researchers; and disseminating authoritative information. 

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DIETARY SUPPLEMENTS

The majority of adults in the United States take one or more dietary supplements either every day or occasionally. Today’s dietary supplements include vitamins, minerals, herbals and botanicals, amino acids, enzymes, and many other products. Dietary supplements come in a variety of forms: traditional tablets, capsules, and powders, as well as drinks and energy bars. Popular supplements include vitamins D and E; minerals like calcium and iron; herbs such as echinacea and garlic; and specialty products like glucosamine, probiotics, and fish oils.

The Dietary Supplement Label

All products labeled as a dietary supplement carry a Supplement Facts panel that lists the contents, amount of active ingredients per serving, and other added ingredients (like fillers, binders, and flavorings). The manufacturer suggests the serving size, but you or your health care provider might decide that a different amount is more appropriate for you.

Effectiveness

If you don’t eat a nutritious variety of foods, some supplements might help you get adequate amounts of essential nutrients. However, supplements can’t take the place of the variety of foods that are important to a healthy diet. Good sources of information on eating well include the Dietary Guidelines for Americansexternal link disclaimer and MyPlateexternal link disclaimer.

Scientific evidence shows that some dietary supplements are beneficial for overall health and for managing some health conditions. For example, calcium and vitamin D are important for keeping bones strong and reducing bone loss; folic acid decreases the risk of certain birth defects; and omega-3 fatty acids from fish oils might help some people with heart disease. Other supplements need more study to determine their value. The U.S. Food and Drug Administration (FDA) does not determine whether dietary supplements are effective before they are marketed.

Safety and Risk

Many supplements contain active ingredients that can have strong effects in the body. Always be alert to the possibility of unexpected side effects, especially when taking a new product.

Supplements are most likely to cause side effects or harm when people take them instead of prescribed medicines or when people take many supplements in combination. Some supplements can increase the risk of bleeding or, if a person takes them before or after surgery, they can affect the person’s response to anesthesia. Dietary supplements can also interact with certain prescription drugs in ways that might cause problems. Here are just a few examples:

Vitamin K can reduce the ability of the blood thinner Coumadin® to prevent blood from clotting.
St. John’s wort can speed the breakdown of many drugs (including antidepressants and birth control pills) and thereby reduce these drugs’ effectiveness.
Antioxidant supplements, like vitamins C and E, might reduce the effectiveness of some types of cancer chemotherapy.
Keep in mind that some ingredients found in dietary supplements are added to a growing number of foods, including breakfast cereals and beverages. As a result, you may be getting more of these ingredients than you think, and more might not be better. Taking more than you need is always more expensive and can also raise your risk of experiencing side effects. For example, getting too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects. Excess iron causes nausea and vomiting and may damage the liver and other organs.

Be cautious about taking dietary supplements if you are pregnant or nursing. Also, be careful about giving them (beyond a basic multivitamin/mineral product) to a child. Most dietary supplements have not been well tested for safety in pregnant women, nursing mothers, or children.

If you suspect that you have had a serious reaction from a dietary supplement, let your health care provider know. He or she may report your experience to the FDA. You may also submit a report to the FDA by calling 800-FDA-1088 or completing a form onlineexternal link disclaimer. In addition, report your reaction to the dietary supplement company by using the contact information on the product label.

Quality

Dietary supplements are complex products. The FDA has established good manufacturing practices (GMPs) for dietary supplements to help ensure their identity, purity, strength, and composition. These GMPs are designed to prevent the inclusion of the wrong ingredient, the addition of too much or too little of an ingredient, the possibility of contamination, and the improper packaging and labeling of a product. The FDA periodically inspects facilities that manufacture dietary supplements.

In addition, several independent organizations offer quality testing and allow products that pass these tests to display their seals of approval. These seals of approval provide assurance that the product was properly manufactured, contains the ingredients listed on the label, and does not contain harmful levels of contaminants. These seals of approval do not guarantee that a product is safe or effective. Organizations that offer this quality testing include:




Don’t take supplements in place of, or in combination with, prescribed medications without your health care provider’s approval.
Check with your health care provider about the supplements you take if you are scheduled to have any type of surgical procedure.
The term “natural” doesn’t always mean safe. A supplement’s safety depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used. Certain herbs (for example, comfrey and kava) can harm the liver.
Before taking a dietary supplement, ask yourself these questions:
What are the potential health benefits of this dietary supplement product?
What are its potential benefits for me?
Does this product have any safety risks?
What is the proper dose to take?
How, when, and for how long should I take it?
If you don’t know the answers to these questions, use the information sources listed in this brochure and talk to your health care providers.

Talk with Your Health Care Provider

Let your health care providers (including doctors, pharmacists, and dietitians) know which dietary supplements you’re taking so that you can discuss what’s best for your overall health. Your health care provider can help you determine which supplements, if any, might be valuable for you.

Keep a record of the supplements you take in one place, just as you should be doing for all of your medicines. Note the specific product name, the dose you take, how often you take it, and the reason why you use each one. You can also bring the products you use with you when you see your health care provider.

Federal Regulation of Dietary Supplements

Dietary supplements are products intended to supplement the diet. They are not drugs and, therefore, are not intended to treat, diagnose, mitigate, prevent, or cure diseases. The FDA is the federal agency that oversees both dietary supplements and medicines.

In general, the FDA regulations for dietary supplements are different from those for prescription or over-the-counter drugs. Unlike drugs, which must be approved by the FDA before they can be marketed, dietary supplements do not require premarket review or approval by the FDA. While the supplement company is responsible for having evidence that their products are safe and the label claims are truthful and not misleading, they do not have to provide that evidence to the FDA before the product is marketed.

Dietary supplement labels may carry certain types of health-related claims. Manufacturers are permitted to say, for example, that a dietary supplement addresses a nutrient deficiency, supports health, or is linked to a particular body function (like immunity or heart health). Such a claim must be followed by the words, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Manufacturers must follow certain good manufacturing practices to ensure the identity, purity, strength, and composition of their products. If the FDA finds a product to be unsafe or otherwise unfit for human consumption, it may take enforcement action to remove the product from the marketplace or work with the manufacturer to voluntarily recall the product.

Also, once a dietary supplement is on the market, the FDA monitors information on the product’s label and package insert to make sure that information about the supplement’s content is accurate and that any claims made for the product are truthful and not misleading. The Federal Trade Commission, which polices product advertising, also requires all information about a dietary supplement product to be truthful and not misleading.

The federal government can take legal action against companies and Web sites that sell dietary supplements when the companies make false or deceptive statements about their products, if they promote them as treatments or cures for diseases, or if their products are unsafe.

Federal Government Information Sources on Dietary Supplements

NATIONAL INSTITUTES OF HEALTH

The National Institutes of Health supports research on dietary supplements.

Office of Dietary Supplements
The Office of Dietary Supplements provides accurate and up-to-date scientific information about dietary supplements.
National Center for Complementary and Alternative Medicineexternal link disclaimer
National Center for Complementary and Alternative Medicine Clearinghouse: 1-888-644-6226
National Library of Medicineexternal link disclaimer
Medline Plusexternal link disclaimer
PubMedexternal link disclaimer
NIH Health Informationexternal link disclaimer
U.S. FOOD AND DRUG ADMINISTRATION

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Food supplements

In the UK most products described as food supplements (such as vitamins, minerals or amino acids) are regulated as foods and subject to the provisions of general food law such as the Food Safety Act. If you sell food supplements you must register as a Food Business Operator (FBO) with the environmental health service at your local authority.


What is a food supplement

A food supplement is defined as ‘any food for the purpose of which is to supplement the normal diet and which is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination and is sold in dose form’. 

What is the role of the FSA?
food supplements
~~The FSA’s main role regarding food supplements is enforcement (setting enforcement policy, co-ordination and advice) with specific responsibility for:
• General food law, food safety legislation and food controls.
• Novel foods
• Chemical risk assessments
• Labelling requirements under the EU Food Information to Consumers Regulation (EU FIC) in Wales and Northern Ireland (Defra in England)
• Enforcement, Incidents and National Food Crime Unit (NFCU).

Local authorities are responsible for the enforcement of food supplements legislation in addition to general food law and food safety legislation. Trading standards officers generally undertake this role. Local authorities do not enforce legislation relating to medicinal products –MHRA is responsible for enforcement in this area .

Department of Health acts as the Competent Authority for the EU legislation on Food Supplements and coordinates policy across the devolved authorities and with other relevant government departments. FSA is responsible for the enforcement of these regulations with local authorities.

MHRA has responsibility for medicinal products (including enforcement) which includes traditional herbal medicines. Herbal substances can be used in both medicines and foods, but where the use is for a medical purpose (either by virtue of the mode of action or the claims that are made) then the MHRA may regard the product, (not the substance), to be medicine. The MHRA has a separate registration scheme, based on traditional use, for certain herbal medicines.
Herbal substances are referred to as botanicals under food law. Products may be considered by the MHRA Borderline Section on a case by case basis to determine whether if the product should be classified as a medicine. The MHRA’s Borderline Section only become involved where there may be doubt regarding a product’s regulatory status, either over the botanical itself, the entire formulation, or the presentation of the product. If a product is not considered medicinal product they typically default to being a food supplement. 

The regulatory landscape for food supplements is complex. The current legislative framework creates overlapping areas of responsibility between several different bodies:

• Food Standards Agency (FSA), Food Standards Agency Wales (FSAW) and Food Standards Agency Northern Ireland (FSANI)
• Food Standards Scotland (FSS)
• Department of Health (DH)
• Home Office (HO)
• Medicine and Healthcare products Regulatory Agency (MHRA)
• Local authorities (LA)
• Welsh Government (WG)



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Nutrition and Supplements for Fitness and Health

Get a well-balanced diet by eating food rather than pills and supplements.
Many diet supplements are not going to help; however there are definite benefits to carbo loading, caffeine, and hydration.

Protein shakes, energy drinks, glucosamine, and creatine have not been scientifically proven to enhance athletic performance.
Athletes need to be aware of their activity level and adjust their calorie intake according to their goals.

Nutrition and Supplements for Fitness and Health

Finding the right balance in your diet has gotten mighty confusing. Dietary guidelines for the best nutrition continue to be revised and rethought. Figuring out what to eat-and what to avoid-has gotten harder and harder to figure out.
The U.S government stepped in 1946 with its first National Nutrition Guidelines. The Basic 7 listed the main food groups for recommended daily intake, including a group for citrus, tomato, cabbage, salad greens, and one for butter and margarine. The plan was revised in 1956 with a simpler approach that featured four food groups. In 1992, the food pyramid was introduced: breads and cereals at the base and sweets at the top. Responding to feedback from physicians that there was too much emphasis on carbohydrates, the pyramid was revised in 2005 as MyPyramid, which added exercise and focused on proportions, variety, and moderation.
“The key is to be aware of what you’re eating and learn about what’s not good for you,” said Bryant Lin, MD, a clinical assistant professor of medicine, who discussed nutrition and diet supplements at a presentation sponsored by the Stanford Health Library. “There’s still some controversy over the current food pyramid, but it’s a reasonable place to start. The key is balance.”

Dr. Lin discussed the components of the pyramid with advice on how to obtain optimal nutrition from your diet. He suggested fresh or frozen fruit since canned fruit usually has too much sugar in the syrup and juice lacks fiber. Reduce quantities of meat, sticking to a 3-ounce serving, and learn where your meat comes from. Eat whole grain foods for roughage.
Athletes, in particular, need to be aware of their activity level and adjust their calorie intake according to their goals. Learn the daily recommended values and read packages carefully to keep track of your nutritional intake. “Exercise by itself is not the way to lose weight permanently,” he said. “For optimal performance you may need to increase calories for your energy needs. Keep track and modify your diet based on your health needs. That’s the nutritional foundation for everyone.”
Dr. Lin also discussed the benefits-and hype-of some of the more common diet supplements and packaged foods. Unlike drugs, which must be approved for safety before entering the market, dietary supplements are not regulated by the FDA.

• Protein shakes, cans, and powders, which are promoted as building muscle mass, do not necessarily make you stronger, said Dr. Lin. “There is little evidence of increased muscle mass over the protein you get in your diet. Since the primary source of protein in your diet is lean meat, that’s probably a better way to go,” he advised. “As long as you’re eating a healthy diet, adding extra protein-either through protein shakes or other sources-isn’t necessary.”
• Creatine is also believed to increase muscle mass, and Dr. Lin said that there is some evidence that it enhances lifting strength. However studies have shown some people have an allergic reaction and the supplement may cause some nominal liver and kidney damage. “It’s not worth the risk,” he said.
• Caffeine supplements, such as Red Bull, NoDoz, coffee, or energy drinks, do appear to improve athletic performance, especially long-term endurance sports like runs of 5K or more.
• Electrolytes, such as potassium and magnesium, conduct electricity in the body, playing a key role in digestion and muscular function, and are often used to treat muscle cramps. Most people get all of the potassium they need from a healthy diet rich in vegetables and fruits, and stretching and hydration are better ways to treat cramps, said Dr. Lin.
• Sports drinks like Gatorade do help improve performance. By mimicking the electrolyte content in sweat, they help with hydration-possibly because many athletes tend to under-hydrate. New electrolyte waters are probably no better than Gatorade, he said, but in general seem to be a reasonable addition to the diet.
• Carbohydrate loading is primarily beneficial if you’re an endurance athlete, such as a marathon runner, swimmer, or cyclist preparing for a high-intensity competition of 90 minutes or more. Carbo loading does appear to enhance endurance performance by increasing glycogen in the muscles.

Glucosamine and chondroitin have been used to treat arthritis or joint pain. However the gastrointestinal track serves as a barrier for products like Joint Juice, Dr. Lin said. Although initial trials showed some joint improvement, two more recent studies did not demonstrate any real benefit from using these proteins. “They won’t do you any good, but they won’t hurt anything but your wallet,” he said.

There are some supplements that have been proven to be beneficial, including:

• Calcium and Vitamin D, since most people do not get enough
• Folic acid, which is especially beneficial for pregnant women and older people
• Omega 3, for high cholesterol. However Dr. Lin expressed concern about levels of mercury in many fish oil supplements and suggested eating walnuts instead.
• Niacin, which also appears to lower cholesterol levels
• Iron, for vegetarians
• “In general, most people can get a well-balanced diet by eating food rather than pills and supplements,” Dr. Lin said. “And count calories and portions in light of your activity level.”
• About the Speaker
• Bryant Lin, MD, is a clinical assistant professor of medicine who specializes in primary care medicine, cardiac electrophysiology research, and biodesign He did his residency and internship at Tufts-New England Medical Center in Massachusetts and competed his fellowships at Stanford. He is Board Certification by the American Board of Internal Medicine. He joined Stanford in 2008.

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FDA 101: Dietary Supplements

The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others

vitamin and mineral products

"botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.

enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.
People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night's sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.

Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care professional before using any dietary supplement. Many supplements contain ingredients that have strong biological effects, and such products may not be safe in all people.
If you have certain health conditions and take these products, you may be putting yourself at risk. Your health care professional can discuss with you whether it is safe for you to take a particular product and whether the product is appropriate for your needs. Here is some general advice:

Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.
Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.
How Are Supplements Regulated?

• You should know the following if you are considering using a dietary supplement.
• Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
• Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
• For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
• In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
• Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
• Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
• Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
• Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
• It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
• There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.
• Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.
Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12. But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

microbiological, pesticide, and heavy metal contamination
absence of a dietary ingredient claimed to be in the product
the presence of more or less than the amount of the dietary ingredient claimed on the label
In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.
Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.

Be a Safe and Informed Consumer

• Let your health care professional advise you on sorting reliable information from questionable information.
• Contact the manufacturer for information about the product you intend to use.
• Be aware that some supplement ingredients, including nutrients and plant components, can be toxic. Also, some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain other drugs, substances, or foods.
• Do not self-diagnose any health condition. Work with health care professionals to determine how best to achieve optimal health.
• Do not substitute a dietary supplement for a prescription medicine or therapy, or for the variety of foods important to a healthful diet.
• Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe.
• Be wary of hype and headlines. Sound health advice is generally based upon research over time, not a single study.
• Learn to spot false claims. If something sounds too good to be true, it probably is.
• Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible. If you experience such an adverse effect, contact or see your health care professional immediately. Both of you are then encouraged to report this problem to FDA. For information on how to do this, go to www.fda.gov/FDAgov/Food/DietarySupplements/Alerts/ucm111110.htm.
Adverse effects can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports they receive about serious adverse effects to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA Consumer Complaint Coordinator.

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Dietary Supplements

The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others

vitamin and mineral products

"botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.
enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.
People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night's sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.
Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care professional before using any dietary supplement. Many supplements contain ingredients that have strong biological effects, and such products may not be safe in all people.
If you have certain health conditions and take these products, you may be putting yourself at risk. Your health care professional can discuss with you whether it is safe for you to take a particular product and whether the product is appropriate for your needs. Here is some general advice:

Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.
Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.

How Are Supplements Regulated?

You should know the following if you are considering using a dietary supplement.
Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.
Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.
Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12. But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

microbiological, pesticide, and heavy metal contamination
absence of a dietary ingredient claimed to be in the product
the presence of more or less than the amount of the dietary ingredient claimed on the label
In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.
Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.

Be a Safe and Informed Consumer

Let your health care professional advise you on sorting reliable information from questionable information.
Contact the manufacturer for information about the product you intend to use.
Be aware that some supplement ingredients, including nutrients and plant components, can be toxic. Also, some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain other drugs, substances, or foods.
Do not self-diagnose any health condition. Work with health care professionals to determine how best to achieve optimal health.
Do not substitute a dietary supplement for a prescription medicine or therapy, or for the variety of foods important to a healthful diet.
Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe.
Be wary of hype and headlines. Sound health advice is generally based upon research over time, not a single study.
Learn to spot false claims. If something sounds too good to be true, it probably is.
Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible. If you experience such an adverse effect, contact or see your health care professional immediately. Both of you are then encouraged to report this problem to FDA. For information on how to do this, go to www.fda.gov/FDAgov/Food/DietarySupplements/Alerts/ucm111110.htm.
Adverse effects can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports they receive about serious adverse effects to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA Consumer Complaint Coordinator.

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Dietary supplement

Food supplement" redirects here. For food additions that alter the flavor, color or longevity of food, see Food additive.

 Bodybuilding supplement

A dietary supplement is either intended to provide nutrients in order to increase the quantity of their consumption, or to provide non-nutrient chemicals which are claimed to have a biologically beneficial effect.

Supplements as generally understood include vitamins, minerals, fiber, fatty acids, or amino acids, among other substances. U.S. authorities define dietary supplements as foods, while elsewhere they may be classified as drugs or other products.

There are more than 50,000 dietary supplements available. More than half of the U.S. adult population (53% – 55%) consume dietary supplements with most common ones being multivitamins.[1]

These products are not intended to prevent or treat any disease and in some circumstances are dangerous, according to the U.S. National Institutes of Health. For those who fail to consume a balanced diet, the agency says that certain supplements "may have value."[2] An exception is vitamin D, which is recommended in Nordic countries[3] due to weak sunlight.




According to the United States Food and Drug Administration (FDA), dietary supplements are products which are not pharmaceutical drugs, food additives like spices or preservatives, or conventional food, and which also meet any of these criteria:[4]

The product is intended to supplement a person's diet, despite it not being usable as a meal replacement

The product is or contains a vitamin, dietary element, herb used for herbalism or botanical used as a medicinal plant, amino acid, any substance which contributes to other food eaten, or any concentrate, metabolite, ingredient, extract, or combination of these things.[4]
The product is labeled as a dietary supplement.[4]
In the United States, the FDA has different monitoring procedures for substances depending on whether they are presented as drugs, food additives, food, or dietary supplements.[4] Dietary supplements are eaten or taken by mouth, and are regulated in United States law as a type of food rather than a type of drug.[5] Like food and unlike drugs, no government approval is required to make or sell dietary supplements; the manufacturer checks the safety of dietary supplements but the government does not; and rather than requiring risk–benefit analysis to prove that the product can be sold like a drug, risk–benefit analysis is only used to petition that food or a dietary supplement is unsafe and should be removed from market.[4]


The intended use of dietary supplements is to ensure that a person gets enough essential nutrients

Dietary supplements should not be used to treat any disease or as preventive healthcare.[7] An exception to this recommendation is the appropriate use of vitamins.[7]

Supplements may create harm in several ways, including over-consumption, particularly of minerals and fat-soluble vitamins which can build up in the body.[8] The products may also cause harm related to their rapid absorption in a short period of time, quality issues such as contamination, or by adverse interactions with other foods and medications.[9]


Main article: Vitamin
Vitamin is an organic compound required by an organism as a vital nutrient in limited amounts.[10] An organic chemical compound (or related set of compounds) is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on the circumstances and on the particular organism. For example, ascorbic acid (vitamin C) is a vitamin for humans, but not for most other animals. Supplementation is important for the treatment of certain health problems but there is little evidence of benefit when used by those who are otherwise healthy.[11]

Dietary mineral

Main article: Mineral (nutrient)
Dietary elements, commonly called "dietary minerals" or "minerals", are the chemical elements required by living organisms, other than the four elements carbon, hydrogen, nitrogen, and oxygen present in common organic molecules.[citation needed]

Amino acids and proteins

Main articles: Amino acid and Protein (nutrient)
Amino acids are biologically important organic compounds composed of amine (-NH2) and carboxylic acid (-COOH) functional groups, along with a side-chain specific to each amino acid. The key elements of an amino acid are carbon, hydrogen, oxygen, and nitrogen, though other elements are found in the side-chains of certain amino acids.

Amino acids can be divided into three categories: essential amino acids, non-essential amino acids, and conditional amino acids. Essential amino acids cannot be made by the body, and must be supplied by food. Non-essential amino acids are made by the body from essential amino acids or in the normal breakdown of proteins. Conditional amino acids are usually not essential, except in times of illness, stress, or for someone challenged with a lifelong medical condition[citation needed].

Essential fatty acids

Main article: Essential fatty acids
Essential fatty acids, or EFAs, are fatty acids that humans and other animals must ingest because the body requires them for good health but cannot synthesize them.[12] The term "essential fatty acid" refers to fatty acids required for biological processes but does not include the fats that only act as fuel.

Bodybuilding supplements

Main article: Bodybuilding supplement
Bodybuilding supplements are dietary supplements commonly used by those involved in bodybuilding and athletics. Bodybuilding supplements may be used to replace meals, enhance weight gain, promote weight loss or improve athletic performance. Among the most widely used are vitamin supplements, protein drinks, branched-chain amino acids (BCAA), glutamine, essential fatty acids, meal replacement products, creatine, weight loss products and testosterone boosters. Supplements are sold either as single ingredient preparations or in the form of "stacks" – proprietary blends of various supplements marketed as offering synergistic advantages. While many bodybuilding supplements are also consumed by the general public their salience and frequency of use may differ when used specifically by bodybuilders.


Industry

In 2013, the global market of vitamins, minerals, and nutritional and herbal supplements (VMHS) was valued at $82 billion, with roughly 28 percent of that in the U.S., where sales increased by approximately $6 billion between 2007 and 2012.[13]

The vitamins and dietary supplements sector in the U.S. grew 4% in 2015, to reach US$27.2 billion. The U.S. market was highly competitive in 2015, as no single company accounted for more than a 5% share of value sales.[14]

Controversy

According to University of Helsinki food safety professor Marina Heinonen, more than 90% of dietary supplement health claims are incorrect.[15] In addition, ingredients listed have been found to be different from the contents. For example, Consumer Reports reported unsafe levels of arsenic, cadmium, lead and mercury in several of the protein powders that were tested.[16] Also, the CBC found that protein spiking (the addition of amino acid filler to manipulate analysis) was not uncommon,[17] however many of the companies involved challenged their claim.[18]

Adverse effects

Some products make extraordinary claims and contain active ingredients which may not have been proven effective.
Among general reasons for harmful effects of dietary supplements are: a) absorption in a short time; b) quality and contamination; and c) enhancing both positive and negative effects at the same time.[19] The number of incidents of liver damage from dietary supplements has tripled in a decade. Most of the products causing that effect were bodybuilding supplements. Some of the victims required liver transplants and some died. A third of the supplements involved contained unlisted steroids.[20] Mild to severe toxicity has occurred on many occasions due to dietary supplements, even when the active ingredients were essential nutrients such as vitamins, minerals or amino acids. This has been a result of adulteration of the product, excessive usage on the part of the consumer, or use by persons at risk for the development of adverse effects. In addition, a number of supplements contain psychoactive drugs, whether of natural or synthetic origin.[21][22]

Physical and chemical properties

Adulteration in North America
BMC Medicine published a study on herbal supplements in 2013. Most of the supplements studied were of low quality, one third did not contain the active ingredient(s) claimed, and one third contained unlisted substances.[23][24]

An investigation by the New York Attorney General’s office reported in 2015 analyzed 78 bottles of herbal supplements from Walmart, Target, Walgreens and GNC stores in New York State using DNA barcoding, a method used to detect labeling fraud in the seafood industry. Only about 20% contained the ingredient on the label.[25][26]

Some supplements were contamined by rodent feces and urine.[27]



Society and culture
Public health
Work done by scientists in the early 20th century on identifying individual nutrients in food and developing ways to manufacture them raised hopes that optimal health could be achieved and diseases prevented by adding them to food and providing people with dietary supplements; while there were successes in preventing vitamin deficiencies, and preventing conditions like neural tube defects by supplementation and food fortification with folic acid, no targeted supplementation or fortification strategies to prevent major diseases like cancer or cardiovascular diseases have proved successful.[28]

For example, while increased consumption of fruits and vegetables are related to decreases in mortality, cardiovascular diseases and cancers, supplementation with key factors found in fruits and vegetable, like antioxidants, vitamins, or minerals, do not help and some have been found to be harmful in some cases.[29][30] In general as of 2016, robust clinical data is lacking, that shows that any kind of dietary supplementation does more good than harm for people who are healthy and eating a reasonable diet but there is clear data showing that dietary pattern and lifestyle choices are associated with health outcomes.[31][32]

As a result of the lack of good data for supplementation and the strong data for dietary pattern, public health recommendations for healthy eating urge people to eat a plant-based diet of whole foods, minimizing processed food, salt and sugar and to get exercise daily, and to abandon Western pattern diets and a sedentary lifestyle.[33][34]:10

Legal regulation
United States
Main article: Regulation of food and dietary supplements by the U.S. Food and Drug Administration
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the standards for a given category of substances.

Regulation in European Union

The European Union's Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[35] Only those supplements that have been proven to be safe may be sold in the bloc without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.


The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[
In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[38] referred to the European Court of Justice by the High Court in London.[

Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[40] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements, and not to vitamins and minerals normally found in or consumed as part of the diet.[

Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.
Research
Effects of most dietary supplements have not been determined in randomized clinical trials and manufacturing is lightly regulated; randomized clinical trials of certain vitamins and antioxidants have found increased mortality rates.

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Nutrition and Supplements for Fitness and Health

Doctors say eating a well-balanced diet is the best way to get the nutrients your body needs. People who think they may need a little extra help often reach for food supplements. These are diet aids, such as vitamins, herbal extracts and fish oil. The companies that sell them suggest they’ll make people healthier. But scientists warn that some of these products actually can make people ill.

Drug stores, groceries and health food shops all sell these products. They’re known as supplements because they are not strictly needed for health. They just supplement — or add to — what people already eat.

They might contain nutrients that are otherwise available from foods. Or they might provide plant-derived materials that work in the same way that drugs do. This might be to boost immunity, increase metabolism (how the body uses energy) or improve how organs of the body work. The caffeine pills that people take to stay awake on long drives are one example of supplements. So are the zinc-based lozenges that people take to fight colds.

Explainer: Some supplements may not have what it takes
Most of these diet aids just provide more of something that is already in the diet. As such, these supplements are supposed to be as safe as food.

Yet each year, a new study finds, food supplements send more than 23,000 people across the United States to emergency rooms (ERs). Each patient had suffered some sort of bad reaction. Doctors refer to such reactions as adverse events. Some people developed chest pains or heart palpitations — a feeling that the heart is beating too fast or hard. Others got headaches or felt dizzy. Still others might have suffered stomach pains, nausea or vomiting.

The study tallying these reactions to food supplements appeared October 15 in the New England Journal of Medicine.

Unexpected number of teens and young adults affected

For the study, researchers collected 10 years of data. These came from the ERs at 63 U.S. hospitals. Supplements had sickened 3,667 of these ER patients, they found. Then the researchers used statistics — various math techniques — to scale up how many times this likely happened if all U.S. hospitals had experienced a similar trend.


The authors were comfortable analyzing these data and making these extrapolations to other hospitals. They all work at the Centers for Disease Control and Prevention (CDC) in Atlanta, Ga., or for the U.S. Food and Drug Administration (FDA) in Washington, D.C. These are government agencies. CDC scientists and doctors make sure Americans receive safe, high-quality health care. The FDA, as its name implies, regulates the safety of food and drugs. For instance, it requires that prescription drugs and over-the-counter medicines (like cough syrups and aspirin) must be tested to show that they are safe and effective. Without tests that show that, FDA won’t let manufacturers sell these products.

Dietary supplements are considered neither foods nor drugs. So for a long while, no government agency had control over their safety or any claims made by the products’ makers. Then, in 1994, Congress wrote a law that ordered FDA to treat supplements like a special kind of food. Back then, FDA said it would assume that supplements are safe enough to sell without going through safety tests. And companies that created new supplements would only have to give FDA data showing why these products were likely to be safe.

The only statement a supplement maker could not make is that its product would cure a disease or condition. That would instantly turn the product into a “drug.” Then, as with other drugs, it would now need to go through strict testing and government controls.

healthy dinner

Andrew Geller is a CDC physician who led the new study. His team was concerned that supplements were not as safe as had been assumed. Why? In the past, he notes, “FDA has recalled supplements that contained unapproved ingredients or were contaminated.”(A recall is when a company must take back a product from stores, hospitals or consumers, usually because of problems with its safety or reliability.) “We didn’t know how many [other types of supplements] caused problems,” Geller says.

So his team reviewed the hospital data. They paid special attention to how old patients were, their symptoms and what supplements they had taken. Then the scientists used data from the studied hospitals to estimate what might be occurring nationally. Adverse events, they found, were not occurring just in older or unhealthy people. Young people were at risk, too.

“Adverse reactions to drugs are usually more common in older people,” noted Geller. “It was surprising," he said, that many adverse reactions to supplements showed up in young people. After all, he notes, these are the people one would expect to be healthiest.

About 11 in every 100 adverse reactions occurred in people between the ages of 5 and 19. Across the United States, that would translate to more than 2,500 ER visits every year by kids and teens. Another 28 out of every 100 adverse events occurred in young adults, aged 20 to 34. That would translate to nearly 6,500 more ER visits yearly. Heart symptoms, such as chest pain and heart palpitations, were the most common effects among young adults.

Not all supplements equally risky

More than half of all side effects that sent people under age 35 to the hospital came from two types of supplements: weight-loss aids and energy boosters.

Weight-loss products come in many forms. They include pills, bars, liquids and powdered-drink mixes. There is no standard formula that all brands share. There also is no consistent list of safe ingredients.

vitamin c 
The label on this bottle of vitamin C tablets notes that the evidence that this supplement reduces cancer risk is not conclusive. If a manufacturer were to make a claim that a product reduces cancer risk, that product would be regulated as a drug, not a supplement.
ROEL SMART/ISTOCKPHOTO
One popular brand of these products, Hydroxycut, includes supplements containing plant-based stimulants such as green-coffee-bean extract and caffeine. Those chemicals can rev up the body’s metabolism — how fast it burns energy. Burn enough and people should lose weight.

But in 2009, FDA ordered Hydroxycut to recall many of its products. Their use had been linked to 23 cases of liver damage. In one case, a 19-year-old boy died.

In a 2013 survey of U.S. high school students, the CDC found that more than 6 out of every 100 high school girls reported taking diet aids without first talking to a doctor. If that trend holds nationally, it would equal roughly 500,000 adolescent girls.

Ruth Milanaik is a pediatrician at Cohen Children’s Medical Center in Lake Success, N.Y. She worries about how diet aids affect teenage bodies. For example, she says Hydroxycut “raises your core body temperature to speed up your metabolism. But teens are growing fast already," she notes. "So making your system run faster can be harmful.”

The company that makes these diet aids says its products are now safe. Still, the products’ labels say these supplements should not be used by anyone under age 18.

Energy supplements also can contain a broad mix of ingredients. These can include caffeine, herbs that produce caffeine-like effects, vitamins and enzymes that are already in our bodies. Some also contain a lot of sugar, especially drinks and those supplements that come in the form of a snack bar.

Some users have complained to the FDA about problems they claim such energy supplements have caused them. Common symptoms include chest pain, the feeling of a racing heart and dizziness. In 2013, the American Medical Association called for a ban on advertising energy drinks to people under age 18 if those products contain “massive and excessive amounts of caffeine.”

These products likely contain stimulants, says the CDC’s Geller. “Symptoms like heart racing and chest pain are very similar to what you see in kids who have taken too much caffeine or … Ritalin.” That last drug, he notes, is a powerful stimulant used to treat ADHD (attention-deficit hyperactivity disorder).

Bulking up?

Pediatricians also worry about body-building supplements. These products promise to help users build muscle. That’s a common goal among teens who play sports, especially games where size is important, such as football.

One of the most popular sports supplements is creatine (KREE-uh-teen). The body already produces some creatine. In muscles, the compound helps produce a chemical called ATP, or adenosine triphosphate (Ah-DEN-oh-seen Try-FOS-fate). ATP carries and releases chemical energy that the body uses for many tasks. One example: ATP provides the energy to power muscle contractions during activities such as lifting weights.

protein supplements

Some supplements, such as creatine, are advertised to athletes and body-builders. But doctors worry that they may not be safe for anyone under age 18.
DAVID VAN DER MARK/FLICKR (CC-BY-SA 2.0)
“The more muscle your body has, the more creatine it makes,” says Milanaik. “But if you don’t have a lot of muscle mass yet and you take creatine, your body will try to get rid of it.” It would excrete the chemical as a waste. And in the process, she says, “That could damage your liver or kidneys.”

Milanaik led three recent studies in which college students posed as 15-year-olds. They called hundreds of health-food stores and pretended to shop for supplements. Girls asked about weight-loss supplements, including Hydroxycut. Boys said they were looking for creatine and products containing the hormone testosterone, which also supports muscle growth.

None of these products are recommended for users under age 18. But many sales clerks recommended them, or were willing to sell them to 15-year-olds, when the callers asked. These studies will be submitted to medical journals within the next few months.

“It’s a lesson that teens need to do their own research,” Milanaik now says. “Warning labels are there for a reason. Just because something comes from a vitamin shop or health food store doesn’t mean it’s good for you.”

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