Are Supplements Safe?

Today’s Health Craze is good. Hopefully, it is a fad that turns into a lifestyle for most of us. But along with our new found interest in diet and exercise, we have renewed interest in what supplements can we take to make us even healthier. Therefore, one should have knowledge about their use and safety prior to purchase.

The need for dietary supplements

Because many products are marketed as dietary supplements, it is important to remember that supplements include vitamins and minerals, as well as herbs, botanicals and other substances.
Some supplements may help ensure that you get adequate amounts of essential nutrients or help promote optimal health and performance if you do not consume a variety of foods, as recommended in the Dietary Guidelines for Americans.

However, dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

Obtaining information on the safety and effectiveness of dietary supplement

Scientific evidence supporting the benefits of some dietary supplements (e.g., vitamins and minerals) is well established for certain health conditions, but others need further study. This is partly due to the way dietary supplements are regulated by the U.S. Food and Drug Administration (FDA).

Research studies in people to prove that a dietary supplement is safe are not required before the supplement is marketed, unlike for drugs. It is the responsibility of dietary supplement manufacturers/distributors to ensure that their products are safe and that their label claims are accurate and truthful. If the FDA finds a supplement to be unsafe once it is on the market, only then can it take action against the manufacturer and/or distributor, such as by issuing a warning or requiring the product to be removed from the marketplace.

The manufacturer does not have to prove that the supplement is effective, unlike for drugs. The manufacturer can say that the product addresses a nutrient deficiency, supports health, or reduces the risk of developing a health problem, if that is true. If the manufacturer does make a claim, it must be followed by the statement "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."

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions. Whatever your choice, supplements should not replace prescribed medications or the variety of foods important to a healthful diet.
Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

Reporting complaints

To report an illness or injury associated with a dietary supplement, please talk with your health care provider and contact the U.S. Food and Drug Administration (FDA): http://www.cfsan.fda.gov/~dms/ds-rept.html

To report a complaint involving misleading advertising, fraud or other consumer protection matters associated with a dietary supplement, please contact the Federal Trade Commission: https://rn.ftc.gov/pls/dod/wsolcq$.startup?Z_ORG_CODE=PU01

Locations to purchase dietary supplements

Dietary supplements are available without a prescription through a number of retail outlets including grocery stores, drug stores, general merchandise retailers, natural food stores and specialty health and nutrition stores. Many dietary supplements can also be purchased on-line through the Internet.

Brand(s) of dietary supplements to purchase

There are a number of factors including price, quality and availability that may influence your buying decision. The Office of Dietary Supplements (ODS) does not test, analyze or rate dietary supplements, nor can we recommend certain brands. You may wish to ask your health care provider to make a recommendation.

If you have questions about a specific brand of dietary supplements, you can contact the manufacturer for more information. Ask to speak to someone who can address your questions, some of which may include:

1. 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 graphs and charts that could be mistaken for well conducted scientific research.

2. Does the firm have information to share about tests it has conducted on the safety or efficacy of the ingredients in the product?

3. Does the firm follow good manufacturing practices and 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?

4. Has the firm received any adverse events reports from consumers using their products?
In addition, there are a few independent organizations that offer “seals of approval” that may be displayed on certain dietary supplement products. These indicate that the product has passed the organization’s quality tests for things such as potency and contaminants. These “seals of approval” do not mean that the product is safe or effective; they provide assurance that the product was properly manufactured, that it contains the ingredients listed on the label and that it does not contain harmful levels of contaminants.

The following is a list of several organizations offering these programs:

• Consumerlab.com approved quality product seal: http://www.consumerlab.com/seal.asp

• NSF International dietary supplement certification: http://www.nsf.org/business/dietary_supplements/index.asp?program=DietarySups

• U.S. Pharmacopeia dietary supplement verification program: http://www.usp.org/USPVerified/dietarySupplements/

How to know whether purchased supplement contains the ingredients that it claims on the label or if it is contaminated

You should be aware that the U.S. Food and Drug Administration (FDA) does not analyze the content of dietary supplements. At this time, supplement manufacturers must meet the requirements of the FDA’s Good Manufacturing Practices (GMPs) for foods. GMPs describe conditions under which products must be prepared, packed, and stored. Food GMPs do not always cover all issues of supplement quality. Some manufacturers voluntarily follow the FDA's GMPs for drugs, which are stricter.

Some manufacturers use the term "standardized" to describe efforts to make their products consistent. However, U.S. law does not define standardization. Therefore, the use of this term (or similar terms such as "verified" or "certified") does not guarantee product quality or consistency.

Responsibility for overseeing the regulation of dietary supplements in the United States

In the United States, the U.S. Food and Drug Administration (FDA) has regulatory responsibility for dietary supplements. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature.

The Federal Trade Commission (FTC) regulates advertising of dietary supplements in national or regional newspapers and magazines; in radio and TV commercials, including infomercials; through direct mail to consumers; or on the Internet. The FTC requires that all information about supplements be truthful and not misleading.

Sources

Dietary Guidelines for Americans. HHS, 2007
http://dietary-supplements.info.nih.gov/Health_Information/ODS_Frequently_Asked_Questions.aspx#Need

National Institute of Health, 2007
http://dietary-supplements.info.nih.gov/Health_Information/ODS_Frequently_Asked_Questions.aspx#Need

National Institute of Health, 2007
http://dietary-supplements.info.nih.gov/Health_Information/ Information_About_Individual_Dietary_Supplements.aspx