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Congressmen Commend FDA’s Increased Priority of Dietary Supplement Activities

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by Ginger Schlueter -

Three members of Congress this week commended FDA for elevating the Dietary Supplement Program from a “division” to an “office” and for FDA’s inspection of, and enforcement against, dietary supplement manufacturers producing products with potentially harmful ingredients.

Because of the high number of Americans who consume at least one dietary supplement per day—approximately half of the population—the lawmakers praised FDA for having documentation of products contaminated with unsafe ingredients. These products violate the 1994 Dietary Supplement Health and Education Act (DSHEA), and, of course, pose potential risks to consumers.

FDA has indicated it conducts approximately 500 yearly inspections and issues about 70-80 warning letters on cGMP (current Good Manufacturing Practices) violations, Reps. Andy Harris, M.D. (R-Maryland), Derek Kilmer (D-Washington) and David Young (R-Iowa) noted in the Dec. 12 letter to FDA Commissioner Scott Gottlieb, M.D. The congressmen encouraged FDA to continue to invest resources into such activities, in addition to their continued collaboration alongside the U.S. Department of Justice to remove illegal dietary supplements from the market.

The letter requested FDA provide Congress with an assessment of the most significant threats, identifying products marketed as dietary supplements that could cause potential harm, and how FDA would use additional funds from Congress. This was in addition to a status update that would include the number of:

  • FDA enforcement actions brought against dietary supplement manufacturers and marketers;
  • cGMP inspections conducted;
  • Full-time employees dedicated to dietary supplement inspections;
  • Reported serious adverse events; and
  • Funds currently allocated to such activities since elevated to an office.

During 2017, the Council for Responsible Nutrition (CRN) met with members of Congress to discuss and explain why FDA needed more funding. The main objectives were to get support for greater enforcement and inspection of the dietary industry by ensuring FDA has sufficient money for regulatory efforts. CRN was met with a lot of interest, but under the current Trump administration, due to budget cuts, there was no more money to distribute.

“This letter is a great example that there are key members in Congress that heard what we were talking about, and a good sign, since Congress wants more information from the FDA,” said CRN's Mike Greene, senior vice president of government relations, in a phone interview.

FDA will be responding “directly to the Congressmen,” Marianna Naum, an FDA spokeswoman, said.

Ultimately, the “letter was a wonderful surprise and it’s great to hear that we were heard,” concluded Greene.

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