viernes, 11 de marzo de 2016

FDA Law Blog: Attorney General Lynch Delivers a Public Service Announcement About DOJ’s Enforcement Actions for Unsafe Dietary Supplements

FDA Law Blog: Attorney General Lynch Delivers a Public Service Announcement About DOJ’s Enforcement Actions for Unsafe Dietary Supplements

Posted: 09 Mar 2016 11:30 PM PST
By Jenifer R. Stach & Wes Siegner –

If you weren’t aware that the Department of Justice (DOJ) has unsafe dietary supplements on its list of enforcement priorities, you should take notice.

On Tuesday March 8th, 2016 as part of National Consumer Protection Week, United States Attorney General Loretta E. Lynch delivered a message in a recorded video emphasizing DOJ’s efforts to protect consumers from unsafe dietary supplements. Given the thousands of consumer products regulated by several branches of the federal government; including the Food and Drug Administration, Federal Trade Commission, Consumer Product Safety Commission, and the National Highway Traffic Safety Administration, it is worthy of notice whenever the Attorney General chooses to focus on any particular category of products.     

Attorney General Lynch’s message reinforces the November 2015 announcement that after a year-long effort, DOJ had engaged in over 100 criminal and civil cases against dietary supplement manufacturers and marketers. Since Congress passed the Dietary Supplement Health and Education Act of 1994 ("DSHEA"), FDA has been criticized for its loose regulation of unsafe, and in certain cases allegedly dangerous ingredients found in dietary supplements.  Attorney General Lynch acknowledges that, “[w]hat many Americans don’t know is that dietary supplements are not subject to testing by the Food and Drug Administration before they reach store shelves – meaning that every day, millions of Americans are ingesting substances whose safety and efficacy are not guaranteed.”  In the video message, she discusses products that purport to provide results they can’t possibly deliver, which is an abuse of consumer trust.  She also discusses dietary supplements that contain harmful ingredients.  Under the FDCA, the basis for such enforcement action is that the products are adulterated, misbranded, or both.  

In one example, Attorney General Lynch highlights recent criminal charges brought against USPlabs executives.  In concluding the video, Attorney General Lynch states that, “bad actors” will be held accountable for their actions.  This is consistent with the September 2015 “Yates memo” (see our blog post here) in which DOJ announced that they intended to hold individuals liable for misdemeanor and felony situations. While Attorney General Lynch emphasizes the importance of DOJ enforcement action, she also sends the message that consumers must take steps to protect themselves.  She directs consumers to consult with a health care provider, check the FDA and FTC websites for dietary supplement information, and use tools developed by the Department of Defense and the U.S. Anti-Doping Agency, including a smartphone app to make informed decisions before taking dietary supplements.  

If the Yates memo was a preview, it has become evident that DOJ is taking action on this policy in the realm of the dietary supplement as well as the food industry (see our blog post here). As we note future DOJ enforcement action, we will be certain to keep you posted.

Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation.  Information on the conference is available here.

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