D.C. Briefing Offers Information on Supplement Labeling

Capitol Hill staffers received tips on understanding dietary supplement labels and the depth of regulation behind supplement labeling during an educational briefing held by the Congressional Dietary Supplement Caucus (DSC), in cooperation with leading trade associations representing the dietary supplement industry.

WASHINGTON—Capitol Hill staffers received tips on understanding dietary supplement labels and the depth of regulation behind supplement labeling during an educational briefing held by the Congressional Dietary Supplement Caucus (DSC), in cooperation with leading trade associations representing the dietary supplement industry.

Jamie McManus, M.D., FAAFP, shared her expertise during the briefing titled, “Understanding Dietary Supplement Labels: Basics & Background." McManus, author of “Your Personal Guide to Wellness," was a practicing family physician for 15 years, and is currently chair, Medical Affairs, Health Sciences and Education at Shaklee Corp.

The Hill staffers in attendance at the DSC briefing learned details about what information must appear on a dietary supplement label and what each item means, including: the statement of identity, net quantity of contents, supplement facts with nutrition information for each ingredient, manufacturer or distributor information, complete listing of ingredients, safety information, FDA disclaimer, claims/benefits and cautions/warnings/notices. They also learned the meanings of key terms such as: estimated average requirements (EAR), recommended dietary allowance (RDA), adequate intake (AI), daily value (DV) and tolerable upper intake level (UL)—making this DSC lunch briefing an opportunity for staffers to learn valuable information for their personal use and to help them better understand issues related to policymaking.

During the briefing, McManus explained that the Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the Federal Food, Drug and Cosmetic Act (FFDCA), created the current framework and regulations for the dietary supplement industry and gave FDA ample authority to regulate these products. According to the law, manufacturers and distributors are responsible for evaluating the safety and labeling of their products before marketing to confirm they meet all the applicable requirements under FFDCA, created to ensure safety and protect consumers. The law requires that companies must submit new dietary ingredient notifications (NDINs) prior to bringing new ingredients to the marketplace, and FDA can object to that new ingredient if the agency deems the safety data to be insufficient. Further, FDA has responsibility for taking action against any adulterated or misbranded dietary supplements in the marketplace. Additionally, dietary supplements are the only category of food that has to report serious adverse events, a requirement for supplements that the industry supports.

The regulatory language of DSHEA also acknowledges that dietary supplements are safe within a broad range of intakes, and that safety problems with supplements are relatively rare, McManus noted. She added that DSHEA was meant to protect consumer access to safe dietary supplements to promote wellness, while establishing a rational federal framework to supersede ad hoc, patchwork regulatory policy that was in place at the time.

DSC educational briefings are held throughout the year, featuring nationally recognized authors, lecturers or authorities on health and wellness who provide tips and insights for better nutrition, including how dietary supplements can contribute to a healthier lifestyle. These briefings also help to educate congressional staff about constituent access to safe and beneficial dietary supplements, and legislative and regulatory issues associated with these products. In addition, DSC members receive regular updates on any new and ongoing developments in the dietary supplement arena.

At the Council for Responsible Nutrition (CRN)’s recent “Day on the Hill" gathering, more than 70 high-level executives met at the U.S. Capitol to urge Congress to pass the Designer Anabolic Steroid Control Act (DASCA) of 2014 and oppose the Dietary Supplement Labeling Act (DSLA).

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