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Dietary Supplement Use & Legal Regulation in the USA by Thomas Cifelli
Published By Tom Cifelli, Executive Editor on August 26, 2010
Dietary Supplements Use & Legal Regulation in the USA
With so many dietary supplements available and so many claims made about health benefits, it is difficult for most people and even doctors to:
Key Points To Know
United States Supplement Usage Summary
A national survey conducted in 2007 found that 17.7 percent of American adults had used “natural products” (i.e., dietary supplements other than multi-vitamins and minerals) in the past 12 months. The most popular products used by adults for health reasons were fish oil/omega 3/DHA (37.4 percent), glucosamine (19.9 percent), echinacea (19.8 percent), flaxseed oil or pills (15.9 percent), and ginseng (14.1 percent).
Dietary Supplement Legal Definition
Dietary supplements were defined in a law passed by Congress in 1994 called the Dietary Supplement Health and Education Act (DSHEA). It was sponsored by Utah legislators and signed by Bill Clinton. According to DSHEA, a dietary supplement is a product that:
Supplement manufacturers and resellers must be careful to only say their products “support” or “help” disease conditions or they could face a cease and desist order and fines. The terms “diagnose,” “prevent” or “cure” must be avoided as use of these terms requires FDA phased drug trial approval. For the specific rules and regulations governing dietary supplement labeling and allowable claims CLICK HERE.
Legal Regulation of the Dietary Supplement Industry
The Federal Government regulates dietary supplements through the U.S. Food and Drug Administration (FDA). The regulations for dietary supplements are not the same as those for prescription or over-the-counter drugs. In general, the regulations for dietary supplements are less strict.
Also, once a dietary supplement is on the market, the FDA monitors product information, such as label claims and package inserts. The Federal Trade Commission (FTC) is also involved regulating product advertising to help assure that all information be truthful and not misleading.
cGMP (Good Manufacturing Practices Standards)
Quality cGMP certified manufacturers start by using the best ingredient suppliers. All good suppliers provide Certificates of Analysis (Cof As) showing what the ingredient is, its quantity, potency, freshness and source/origination information. cGMP standards do not apply to ingredient suppliers yet, they do now apply to all size of manufacturers in the USA.
The best cGMP manufacturers have and use internal testing equipment to verify for themselves the quality and toxicity of ingredient batches. Many use third party testing facilities as well.
Maintaining a paper trail in the event of FDA audits is a big part of complying with cGMP standards. There are different “scores” on cGMP compliant manufacturers. Few are rated “excellent.” Some of the more critical things impacting a cGMP rating include:
Sources of Science-Based Information for Dietary Supplements
It’s important to look for reliable sources of information on dietary supplements so you can evaluate the claims that are made about them. The most reliable information on dietary supplements is based on the results of rigorous scientific testing. We believe OWC’s “Research” library will soon emerge as the most comprehensive and trusted “go-to” source for state-of-the-art information on nutritional ingredients and supplements in the world.
To get reliable information on a particular dietary supplement:
Safety Considerations of Dietary Supplements
If you are thinking about or are using a dietary supplement, here are some points to keep in mind.
Tell your health care providers about any complementary and alternative practices you use, including dietary supplements. Give them a full picture of what you do to manage your health. This will help ensure coordinated and safe care. (For tips about talking with your health care providers about complementary and alternative medicine (CAM), see NCCAM’s Time to Talk campaign at nccam.nih.gov/timetotalk.) It is especially important to talk to your health care provider if you are
If you are taking a dietary supplement, read the label instructions. Talk to your health care provider if you have any questions, particularly about the best dosage for you to take. If you experience any side effects that concern you, stop taking the dietary supplement, and contact your health care provider.
If you can afford it, we absolutely recommend you find a naturopathic doctor or other nutrition expert to consult with and have them if possible collaborate with your conventional medicine doctors. Conventional medicine doctors must practice within “Standards of Care” which may preclude them from supporting or bringing alternative therapies to your attention. [Click Here] for more on this in an article discussing cancer care controversy.
Also consider the possibility that what’s on the label may not be what’s in the bottle. All manufacturers are not alike. We suggest NOT buying products that are produced anywhere else except in a cGMP certified facility. Or simply shop in OWC’s Shop for the best of the best high quality products available anywhere in one place.
Analyses of dietary supplements sometimes find differences between labeled and actual ingredients. For example:
For current information from the Federal Government on the safety of particular dietary supplements, check the “Dietary Supplement and Safety Information” section of the FDA Web site at www.fda.gov/Food/DietarySupplements/Alerts/ or the “Alerts and Advisories” section of the NCCAM Web site at nccam.nih.gov/news/alerts.
Dietary Supplements Research at the National Institutes of Health
NCCAM, which is part of the NIH, is the Federal Government’s lead agency for studying all types of CAM. As part of that role, the Center sponsors a wide array of research to see how dietary supplements might affect the body and tests their use in clinical trials. In fiscal year 2007, NCCAM supported more than 200 research projects studying dietary supplements, including herbs and botanicals.
Also within NIH, the ODS focuses specifically on dietary supplements, seeking to strengthen knowledge by supporting and evaluating research, disseminating results, and educating the public.
NCCAM and ODS collaborate to fund dietary supplement research centers focused on botanicals, known collectively as the NIH Botanical Research Centers Program. Scientists at the centers conduct basic research and other studies on botanicals and help to select products to be tested in clinical trials. The centers are advancing the scientific base of knowledge about botanicals, making it possible to better evaluate their safety and effectiveness.
NCCAM also sponsors a number of Centers of Excellence for Research on CAM, including centers studying antioxidant therapies, botanicals for autoimmune and inflammatory diseases, grape-derived polyphenols for Alzheimer’s disease, and botanicals for pancreatic diseases and for colorectal cancer.
Selected References
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For More Information:
NCCAM Clearinghouse
The NCCAM Clearinghouse provides information on CAM and NCCAM, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.
Toll-free in the U.S.: 1-888-644-6226
TTY (for deaf and hard-of-hearing callers): 1-866-464-3615
Web site: nccam.nih.gov
E-mail: info@nccam.nih.gov
Office of Dietary Supplements (ODS)
ODS seeks to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, supporting research, sharing research results, and educating the public. Its resources include publications (such as What Dietary Supplements Are You Taking?), fact sheets on a variety of specific supplement ingredients (such as vitamin D and black cohosh), and the International Bibliographic Information on Dietary Supplements (IBIDS) database.
Web site: www.ods.od.nih.gov
E-mail: ods@nih.gov
U.S. Food and Drug Administration (FDA)
The FDA oversees the safety of many products, such as foods, medicines, dietary supplements, medical devices, and cosmetics. Its series of consumer updates includes the publication FDA 101: Dietary Supplements.
Web site: www.fda.gov
Toll-free in the U.S.: 1-888-463-6332
Center for Food Safety and Applied Nutrition (CFSAN)
CFSAN oversees the safety and labeling of supplements, foods, and cosmetics. Online resources for consumers include “Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information” and dietary supplement safety alerts.
Web site: www.fda.gov/AboutFDA/CentersOffices/CFSAN/
Toll-free in the U.S.: 1-888-723-3366
MedWatch
MedWatch, the FDA’s safety information and adverse event reporting program, allows consumers and health care providers to file reports on serious problems suspected with dietary supplements.
Web site: www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
Toll-free in the U.S.: 1-888-463-6332
Federal Trade Commission (FTC)
The FTC is the Federal agency charged with protecting the public against unfair and deceptive business practices. A key area of its work is the regulation of advertising (except for prescription drugs and medical devices).
Web site: ftc.gov
Toll-free in the U.S.: 1-877-382-4357
PubMed®
A service of the National Library of Medicine (NLM), PubMed® contains publication information and (in most cases) brief summaries of articles from scientific and medical journals. CAM on PubMed®, developed jointly by NCCAM and NLM, is a subset of the PubMed® system and focuses on the topic of CAM.
Web site: www.ncbi.nlm.nih.gov/sites/entrez
CAM on PubMed®: nccam.nih.gov/research/camonpubmed/
National Library of Medicine’s MedlinePlus and
Dietary Supplements Labels Database
To provide resources that help answer health questions, MedlinePlus brings together authoritative information from the National Institutes of Health as well as other Government agencies and health-related organizations.
Web site: www.medlineplus.gov
The Dietary Supplements Labels Database provides information about ingredients in more than 2,000 selected brands of dietary supplements, including vitamins, minerals, herbs or other botanicals, amino acids, and other specialty supplements.
Web site: dietarysupplements.nlm.nih.gov/dietary
This information is not intended to substitute for the medical expertise and advice of your primary health care provider. We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by OWC.
Visit “Heart Disease” in our Research library for examples of other good supplement information sources.
(c) Thomas “Tom” Cifelli, Executive Editor, August 26, 2010.