Dietary Supplement Use & Legal Regulation in the USA by Thomas Cifelli

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:

• decide what’s safe and effective
• decide which products are the highest quality (in terms of both formulation and ingredient quality)
• decide which products are best for their individual needs.
  

Key Points To Know

• Federal regulations for dietary supplements are very different from those for prescription and over-the-counter drugs. For example, dietary supplements do not need prior approval before being marketed. On the other hand, drugs need to go through expensive time consuming phased trials before they can be sold.
• The focus of supplement regulation is on quality controls in the manufacturing process, on required label disclosures and on marketing claims. Most compliance issues center around labeling deficiencies and over-zealous marketing claims. In May 2010 the US government GAO issued a report on deceptive marketing practices by herbal supplement marketers and manufacturers highlighting the importance of dealing with a trustworthy source of information and products such as Online Wellness Community. CLICK HERE for a summary of this interesting GAO report. Increased enforcement of manufacturing standards (Good Manufacturing Practicies aka cGMPs) is expected now that cGMP standards have been phased in for all sizes of manufacturers.
• Because it is nearly impossible to get meaningful patent protection on nutritional supplement product formulations and delivery systems, there is no incentive for anyone to spend the time and money required to “prove” by medical drug standards a direct targeted health benefit from dietary supplement formulations.
• Nearly all studies done target a single nutrient over a short time span despite it being widely agreed that nutrient and food ingredients seem to work best in combination with regular prolonged use as you will learn by studying the material in our “Research” library. Rather than negative complications from prolonged use as is common with drugs, regular prolonged use of quality therapeutic dose levels of nutrient arrays are believed to have compounded beneficial effects.
• Many of the studies on natural nutrients are designed for failure … consider a recent pharmaceutical backed study on the effectiveness of Omega 3 intake. It involved people 60 to 80 years of age in Europe with heart disease taking margarine with Omega added and margarine without. The levels were very low and the delivery system unhealthy (margarine use) so the conclusion of no definite heart disease benefit is not useful or reliable. Unfortunately there are many financially interested and powerful parties out there who would not benefit by people staying healthier longer with reduced drug and surgery use. So these kind of ridiculous studies giving supplements a bad rap continue to be promoted and published.
• Even FDA certified (cGMP) manufacturing plants have many discretionary measures and certifications they can obtain to assure super quality … these include supply chain quality assurance programs and independent testing procedures of both raw materials and finished products.

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).

• In an earlier national survey covering all types of dietary supplements, approximately 52 percent of adult respondents said they had used some type of supplement in the last 30 days – most commonly multi-vitamins & mineral products. As more consumers become aware they can incorporate advanced meal replacement supplement products in their diet without increasing their food budget, the daily use of dietary super food supplements should approach 100% amongst educated consumers.

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:

• Is intended to supplement the diet;
• Contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and certain other substances) or their constituents;
• Is intended to be taken by mouth, in forms such as tablet, capsule, powder, softgel, gelcap, or liquid.
• Is labeled as being a dietary supplement. Some raw food powder products, including some of our favorites MRPs and superfoods in our OWC Shop, are considered food by the manufacturers and are not labeled as dietary supplements. This seems to be a growing grey area. Our preference is to comply with food and supplement labeling standards even though this discloses more information making formulations easier for competitors to attempt to “copy.”

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.

• A manufacturer does not have to prove the safety and effectiveness of a dietary supplement before it is marketed. A manufacturer is permitted to say that a dietary supplement addresses a nutrient deficiency, supports health, or is linked to a particular body function (e.g., immunity), if there is research to support the claim. Such a claim must be followed by the words “This statement has not been evaluated by the U.S. Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.”
• Manufacturers are expected to follow certain “good manufacturing practices” (GMPs) to ensure that dietary supplements are processed consistently and meet quality standards. Requirements for GMPs went into effect in 2008 for large manufacturers and are being phased in for small manufacturers through 2010. OWC executives have personal relationships with some leading cGMP plants, have even worked for and consulted to some, and were involved in formulating very advanced daily supplements with Board Certified Anti-Aging medical doctors. So we have significant related expertise amongst our team.
• Once a dietary supplement is on the market, the FDA monitors safety. If it finds a product to be unsafe, it can take action against the manufacturer and/or distributor, and may issue a warning or require that the product be removed from the marketplace.
• The FTC has advertising and marketing regulations impacting supplements and functional food products as well.

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:

• Material receiving areas and procedures,
• Material testing facilities and procedures,
• Equipment cleaning and testing procedures,
• Clean room features and separation of processes to prevent contamination,
• Air and temperature control technologies,
• Water filtration technologies,
• Employee safety and cleanliness procedures,
• Other process control procedures,
• How often they test batches for nutritional consistency,
• Maintenance of specification sheets and C of As,
• Frequency of heavy metal analysis,
• Storage and shipping procedures on finished product.

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:

• Ask your health care providers. Even if they do not know about a specific dietary supplement, they may be able to access the latest medical guidance about its uses and risks (although we must caution you conventional medicine sources are behind the science and seem to be in many cases closed minded on this issue for a variety of reasons).
• Look for scientific research findings on the dietary supplement. The National Center for Complementary and Alternative Medicine (NCCAM) and the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), as well as other Federal agencies, have free publications, clearinghouses, and information on their Web sites.
• Most importantly, use OWC’s keyword site search tool at the top of the site and explore our “Research” pages.

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

• Thinking about replacing your regular medication with one or more dietary supplements.
• Taking any medications (whether prescription or over-the-counter), as some dietary supplements have been found to interact with medications.
• Planning to have surgery. Certain dietary supplements may increase the risk of bleeding or affect the response to anesthesia.
• Pregnant or nursing a baby, or are considering giving a child a dietary supplement. Most dietary supplements have not been tested in pregnant women, nursing mothers, or children.

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:

• An herbal supplement may not contain the correct plant species or may not contain a quality potent bio-available source of that ingredient (there is a huge variance in costs of ingredients between differing supply sources and the old adage you get what you pay for applies here as well).
• The amount of the active ingredient may be lower or higher than the label states. That means you may be taking less—or more—of the dietary supplement than you realize.
• The dietary supplement may be contaminated with other herbs, pesticides, or metals, or even adulterated with unlabeled ingredients such as prescription drugs.
• Many of the products in box retail stores, while priced low compared to some perhaps even some of those in our member store, are not worth spending any money on for one or more of the above factors.

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

• Barnes PM, Bloom B, Nahin R. Complementary and alternative medicine use among adults and children: United States, 2007. CDC National Health Statistics Report #12. 2008.
• Dietary Supplement Health and Education Act of 1994. U.S. Food and Drug Administration Web site. Accessed athttp://www.fda.gov/RegulatoryInformation/Legislation/ on May 12, 2008.
• Dietary supplements: background information. Office of Dietary Supplements Web site. Accessed at ods.od.nih.gov/factsheets/DietarySupplements_pf.asp on November 18, 2008.
• Dietary supplements: overview. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition Web site. Accessed atwww.fda.gov/Food/DietarySupplements/ on May 12, 2008.
• Natural Medicines Comprehensive Database. Product monographs. Accessed at www.naturaldatabase.com on May 13, 2008.
• Radimer K, Bindewald B, Hughes J, et al. Dietary supplement use by US adults: data from the National Health and Nutrition Examination Survey, 1999–2000.American Journal of Epidemiology. 2004;160(4):339–349.

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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.