Sunday, July 21st, 2019

FDA: Massive Attack on Supplements

Published on August 19, 2016 by   ·   No Comments

leaf-supplements-web

 

The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news. Highest-level Action Alert!

We normally publish our newsletter on Tuesday, but are sending out this issue today because of its urgency.

What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately.

Over the last few years, one of the biggest issues facing the supplement industry has been the confusion over how to comply with the new dietary ingredient (NDI) provisions contained in the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA), the main law governing supplements. For the layman, “new dietary ingredient” is usually just government jargon for “new supplement.”

Under DSHEA, any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product.

In 2011, the FDA released a draft guidance setting forth the agency’s thinking on how companies should comply with DSHEA’s NDI requirements: how and when a NDI notification should be submitted, what information should be included, what is or is not considered an NDI, etc.

The 2011 draft guidance was a massive broadside aimed at crippling—if not eliminating—the supplement industry. An economic analysis at the time by an Emory University professor estimated that the FDA’s outrageous interpretation of the DSHEA-mandated NDI notification language would have meant:

  • the elimination of tens of thousands of supplements from the market;
  • an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
  • the loss of between 55,270 and 104,475 jobs in the supplement industry.

ANH-USA and others submitted detailed comments to the FDA concerning its deeply flawed guidance document, and ANH-USA members flooded the agency with comments. After a major backlash of 146,000 pages of comments, Congressman Peter Roskam (R-IL)stepped in and said the FDA had reversed the intent of DSHEA, which was meant to expand, not restrict, consumer access to supplements.

ANH-USA and our partners were then able to persuade Congress to add language to an appropriations bill urging the FDA to go back to the drawing board, and the agency eventually agreed. We have been waiting for the agency’s updated draft ever since.

We need to keep in mind some history about this and in particular why DSHEA was passed in the first place. In 1992, the FDA published its Task Force Report on Dietary Supplements. It included the statement that dietary supplements represented adisincentive for patented drug research.”

This report, plus the news that the clinic of Dr. Jonathan Wright had been raided at gunpoint (later referred to as “The Great B Vitamin Bust”), sent shockwaves through every integrative doctor’s office and every health food store in America.

Read More HERE

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