AER

History of Supplement Safety Regulations

Among the significant recent amendments to the Food, Drug and Cosmetic Act (FD&C), relative to the dietary supplement industry, were the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the Dietary Supplement and Non-Prescription Drug Consumer Act of 2006, also known as the adverse event report (AER) law. A late addition to DSHEA gave a sliver of premarket oversight to FDA in the form of mandatory new dietary ingredient (NDI) notifications. More than a decade later, Congress and industry teamed up to address post-market safety of supplements with a law requiring submission of serious AERs to FDA.

One of the common misconceptions is dietary supplements are not regulated, and scrutiny of this industry have focused on safety. Regulation of dietary supplement safety can be found in the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the Dietary Supplement and Non-Prescription Drug Consumer Act of 2006, also known as the adverse event report (AER) law.

Much of DSHEA was hashed out between industry and FDA via various U.S. Congressman, including Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) and Rep. Henry Waxman (D-California). The crux of the battle was industry’s refusal to accept FDA’s desire to regulate supplement ingredients as food additives, while the agency wanted more authority to ensure the quality and safety of supplements. After lengthy negotiation and compromise, DSHEA established a primarily post-market regulatory structure for dietary supplements, but one section required some level of premarket notification to FDA, new dietary ingredient (NDI) notification.

More than a decade after DSHEA passed, Congress and industry teamed up to address post-market safety of supplements with a law requiring submission of serious AERs to FDA. The agency was lamenting the difficulty it experienced with ephedra, which it ending up banning for safety reasons. Companies were not required to submit AERs to FDA, and the current federal system for collecting and analyzing safety data, including AERs, was woefully outdated an ineffective. In a span of a few years starting in 2003, FDA launched an improved AER management system and worked with Congress and industry to pass the AER bill in late 2006.

The history of these two safety regulations is an interesting mix of passion and compromise:

Which safety regulation surfaced at the last minute, after almost a year of behind-the-scenes negotiation?

What does Thanksgiving have to do with NDIs?

Why did the industry agree to mandatory serious AER submissions?

Did the industry foresee future problems with FDA over NDIs?

The special report, “History of NDIs, AERS," will shed some light on the events, people, organizations and legislative circumstances that influenced the NDI and AER bills and their passage.

Hide comments

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish