Homeopathic Product Disease Claims
Measles claims attract scrutiny
Homeopathic products continue to be targeted by FDA. In this group of five warning letters FDA reinforced their position that homeopathics are drugs and must follow drug rules, including FDA approval.
From warning letter. “(the products) are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.”
A common thread in these letters are claims about measles prevention and support. FDA takes these types of claims seriously as they want to avoid consumers foregoing conventional treatment for potentially unproven therapy. FDA has issued numerous homeopathic-related warning letters over the past few years and they primarily focus on serious disease claims or potentially dangerous products such as opthalimic (eye) products. Check out some of my previous WLW posts on these topics.
Some of the companies in these warning letters are distributors. FDA has cited product distributors like Amazon and Walmart in the past but recently they’ve also focused on smaller distributors. This reinforces the lesson that all companies are responsible for the products they distribute, especially if they handle the product.
Here is the Homeopathic Drug Products: Guidance. This guidance, together with the warning letter comments, offers insight into FDA’s current thinking on homeopathic enforcement priorities and its use of “enforcement discretion.”
Read the five warning letters here:
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