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

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Mon, Jun 04, 2018
Length
60 minutes
Product Description

Mandatory Recall Under the Food Safety Act Authority


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.

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 industry veteran Casper Uldricks 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.

Session Highlights

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.

Who Should Attend

  • Regulatory affairs directors
  • Recall managers
  • Marketing directors
  • FDA consultants
  • Importers of dietary supplements
  • In-house legal counsel

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Casper E. Uldriks

 Casper (Cap) Uldriks brings over 32 years of experience from the FDA.  He specializes in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He...   More Info
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