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March 4, 2010
5 Min Read
This year will mark the 13th consecutive spring that I have attended the NPA's Natural Products Lobby Day and spent a full day learning about the issues confronting the dietary supplement industry as well as positive programs we are seeking to support in Washington, DC. I have always found the time I have spent meeting with and lobbying my Senators and Member of the House of Representatives incredibly enjoyable and stimulating. On several occasions this event has coincided with serious challenges facing the industry, not the least involved issues surrounding ephedra and proposed legislation that would have rolled back much of DSHEA.
This year, however, I believe the confluence of three significant trends makes participation "in lobby day" particularly important.
Meanwhile, FDA has continued to refuse to announce whether it believes that certain parts of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (that's three years ago) that are designed to prevent the addition of "drugs" to food apply to dietary supplements. Because FDA has suggested that it believes that the word "drug" in FDAAA has an incredibly broad meaning, even in the absence of any indication that Congress intended this part of the law to apply to supplements, FDA sought public comment on the subject in July of 2008. The comment period closed in October of that year. Some 28 months later, FDA has yet to speak on this issue other than to continue to suggest that FDAAA may threaten the viability of numerous supplement ingredients.
FDA: On Dec. 4, 2009, FDA announced the availability of a new draft guidance, "Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements From Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods." This document announced FDA's intention to, among other things, significantly restrict the category of liquid products that could be marketed as dietary supplements by declaring that any product utilizing packaging that resembles a conventional beverage could not be sold as a supplement.
The Mass Media: Hardly a day passes without a major mass media outlet "reporting" that dietary supplements are "unregulated", "virtually unregulated" or "lightly regulated". In particular, influential publications such as The New York Times, The Chicago Tribune and The Los Angeles Times frequently run articles discussing supplement-drug interaction, steroid adulteration, and supplement recalls attributing, these problems not to lax enforcement of existing laws, but to the supposed absence of regulations created by DSHEA. So far the supplement industry has been remarkably "Teflon" to any effect from these stories, but sooner or later the drumbeat of "unregulated" will almost certainly have an impact.
Congress: It's been 16 years since the passage of DSHEA. Many members of Congress and virtually all of the staffers who were there in 1994 are long gone. Support for the notion that consumers should have free access to dietary supplements in order to assist in taking control of their own health decisions cannot be taken for granted. Instead we are confronted with a Congress containing a large number of skeptics who identify dietary supplements with bogus weight loss pills, contaminated "male enhancement products" and steroids.
Against this background on February 3, 2010, Senator (and former Presidential Candidate) John McCain (R-AZ) introduced The Dietary Supplement Safety Act of 2010 ("DSSA"). According to Senator McCain, the bill was introduced in order to address the "problem" of steroid contaminated supplements and is designed to ensure that "Americans… know the exact ingredients of any dietary supplement they use and the FDA must have the tools necessary to ensure the safety of dietary supplements". Unfortunately, in crafting this proposed legislation, Senator McCain ignored the fact that the current law already makes it illegal to sell steroids masquerading as dietary supplements as well as requiring all ingredients to be listed on product labels. Instead he attempted to address his concerns by proposing that DSHEA be essentially repealed and that only those dietary supplements on an affirmative "approved list" developed by FDA be sold without undergoing review under FDA's New Dietary Ingredient review process. (Anyone who has attempted to deal with NDI issues understands exactly what a quagmire this is). Senator McCain is supported in his efforts by the United States Anti-Doping Agency, Major League Baseball, The National Football League and numerous other sports associations that would prefer to talk about DHSEA and supplements instead of athletes who cheat. While Senator McCain has committed to Senator Orrin Hatch (R-UT) that he will be modifying his position on several of these issues, he has not revealed exactly what modifications he would be open to and has not given any indication that he has any plans on withdrawing this bill. If passed, the DSSA would significantly restrict the category of products that could be legally marketed as dietary supplements.
So, as we get ready to go to Washington for Natural Products Day the supplement industry confronts (1) a regulator actively seeking to narrow the category of products that can be legally sold as dietary supplements, (2) a steady message from the mass media that the supplement industry is "out of control" and "unregulated" and (3) legislation sponsored by a powerful Senator and supported by Major League Baseball that would essentially repeal DSEHA and "reregulate" supplements.
On March 23, you need to be at Natural Products Day and tell your representative and Senators that the supplement industry is regulated, sells products that provide numerous health benefits, employs thousands of people and supports their families, and that all we really want is for FDA to do its job and enforce a good law called DSHEA that is already on the books.
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