ANH-USA Files Emord-Drafted Analysis with FDA that Reveals Cockeyed Assumptions Behind Proposed New Supplement GuidanceAugust 23, 2011
The FDA says all new supplements since 1994 must be approved, but this will result in only 55 new applications. Huh? Experts predict as many as 125,000, and sale of these supplements will be illegal while the FDA decides what to do with them all.
Our analysis was created in response to an FDA statement in the Federal Register which grossly underestimated the burden of the proposed new guidance. It was drafted by renowned constitutional law attorney Jonathan Emord, with economic analysis by Dr. Joanna Shepherd Bailey, Associate Professor of Law at Emory University. Here are some additional findings:
- The FDA’s new guidance can be expected to cause major disruption in the dietary supplement industry, forcing significant numbers of products off the market, losing over $1 billion in revenue, and forcing over 100,000 Americans to lose their jobs.
- Rather than the 20 employee hours the FDA says are needed to do an NDI submission, our analysis shows it will cost between 100 and 350 hours of employee time. This will place the total cost to prepare these supplement approval applications (“notifications”) at between $845 million and $6.1 billion in employee wages.
- Animal and human product safety studies will cost between $450,000 and $6.6 million per notification, for a total cost to industry of between $2 billion and $165 billion.
- Where will industry be expected to get this money except from price increases? Supplements are already expensive. Millions more Americans won’t be able to afford them—just what the FDA and the drug industry would seem to want. It is a one-two thrust: Fail to approve many supplements, then make the rest too expensive for the average consumer.
- The federal government will lose between $1.84 billion to $3.54 billion in federal tax revenues; state and local governments will lose between $1.64 billion and $3.07 billion in taxes.
- Natural health is a huge growth industry. It is an area in which America has a competitive advantage. It can save billions in medical costs. But the federal government in the form of the FDA seems to want to shut it down. It is up to us, citizens and consumers, to tell them no.
Save the Date!
We are organizing a Call-In Lobbying Day on Thursday, September 8. This will be a coordinated effort and we are asking each of you—members, grassroots activists, readers, and friends—to set some time aside on that day to phone your senators and representatives and voice your opposition to the NDI (dietary supplement) guidance. We will have full details for you soon, including contact information and clear talking points so you can make your phone calls with confidence.