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FDA Guidance and Opioid Cessation Unapproved Drugs

  • Debra Topham
  • Feb 1, 2018
  • 2 min read


This week Hyman, Phelps, McNamara PC, in their FDA Law Blog, summarizes two recent FDA events, and provides some insights into their impact. I’ll provide a top line summary.  But you should read the the full articles if you want to understand the background.


  • Essentially the FDA has issued guidance documents.

  • Guidance is supposed to be just that guidance and not legally binding.

  • However guidance has been cited as a reason in FDA Warning Letters, which makes guidance, tacitly, an enforceable regulation.

  • Now theres some push back, the DOJ announced that it will prohibit DOJ from using its civil enforcement authority to convert other agency guidance documents into binding rules.

  • That’s huge!!!   In short this suggests, that an agency can’t use a guidance document to create a new enforceable regulation!


  • The FDA and the Federal Trade Commission (FTC)  jointly posted warning letters to 11 marketers and distributors of opioid cessation products.

  • Releasing double-digit letters together emphasizes their seriousness of the issue.

  • The FDA rules are clear, dietary supplements and homeopathic remedies, cannot make drug claims.

  • A drug claim treats a disease. Per 21 CFR 109.93(g) a “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.”

  • Opioid addiction is a  disease; and prevents the body from functioning properly (i.e. addiction is not normal)

  • As such the 11 companies, are selling unapproved drugs. They have 15 days to respond.


As always please consult your attorney; this information is not intended as legal advice. Knowledge Bank is not a law firm nor do we provide legal advice.

Picture – Justice Department

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