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.
- Guidance on Guidance
- 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!
- Joint Action by FDA and FTC Against Companies Marketing Unapproved Opioid Cessation Products
- 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