This message is sent to you by FDA Newswatch

FDA Precedent: Procedural Steps to Issue a Mandatory Recall of Herbal Drug

Thursday, 24 January 2019 10:00 AM PST, 01:00 PM EST

Training Duration = 60 Minutes                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

The FDA set a precedent of issuing a mandatory recall under the Food Safety Act authority. The FDA applied, in part, a statutory authority for foods to a drug substance.

Perhaps, the scope of the FDA's mandatory recall for food finds a back door for ordering drugs off of the market. Was the product really a dietary supplement, as claimed by the distributor or did the FDA deem the dietary supplement as a drug?

This raises issues of a product falling under a food classification and a drug metabolic action. There are lessons emerging from this for drug marketers, re-labelers, and manufacturers. How does this precedent change your view of recall management now that foods, drugs, and devices all face the possibility of a mandatory recall in one way or the other?

The FDA's action here is a two-for-one hit and in the interest of public health, which seems to be a fortuitous move in protecting the public health. It draws attention to the agency's mandatory recall authority under the Food Safety Act and illustrates how dietary supplements can veil the fact that they can be dangerous. Public policy seems to be as much a part of the considerations in this case as are the dangers of Salmonella poisoning.

Learning Objectives:

This instructive program will discuss:

  • How can a food mandatory recall authority be used against a drug?
  • Association with opioid usage that bolsters an enforcement precedent
  • Basis for recall due to Salmonella contamination
  • Procedural steps to issue a mandatory recall (voluntary vs. mandatory)
  • Subsequent enforcement or legal actions for a precedent setting mandatory recall
  • Questions going forward about where this recall could lead

Why Should You Attend:

The Food Safety Act authority covers dietary supplements, and in this case, Salmonella was an easy justification. However, it sets up a fusion of food mandatory recall authority with drug substances. For foods, it is an explicit authority; however, it is not so clear for drugs. Join this session, where speaker will set forth the facts that led to the surprising use of a mandatory recall, and how it crosses over into the world of drugs.

The confusing administrative use of the FDA's recall authority requires some assessment to see how product jurisdiction is implicitly vague. Are there other "urgent" public health circumstances that will follow this unforeseen regulatory bridge over to drugs? The door is open for even more enforcement surprises for food firms and drug firms.

Instructor Profile

Mr. Casper Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs.

He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.

Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.