This private blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
12 March 2021 — The Federal Appeals Court that serves the West Coast made a decision that supports commercial freedom of speech regarding dietary supplements. Reuters reports:
A class action lawsuit accusing big box retailer Target Corp and nutritional supplement makers International Vitamin Corp and Perrigo Co of falsely marketing biotin, a nutritional supplement, as promoting healthy hair and skin is preempted by federal law, a federal appeals court has ruled.
A unanimous panel of the 9th U.S. Circuit Court of Appeals held …that the claims made on the supplement’s label were protected by the federal Food, Drug and Cosmetic Act (FDCA) as general claims about the structure and function of biotin, and that the product included appropriate disclaimers, affirming a lower court order dismissing the case.
What this means is that States like California cannot impose stricter “false advertising” rules than the Federal Government imposes. It means there is a national standard for claims. When general structure and function claims are made — with appropriate disclaimers — Federal law protects the claims.
Isn’t it time for us to review your claims and make sure your disclaimers are in order? Just email me: firstname.lastname@example.org with “Review” in the subject line. Ten percent off my regular rates if you email your questions.
While claims are the key for marketing natural products, including dietary supplements, careful consideration of claims is not enough to keep you in business.
Your processing system must be “in order” and, as FDA says, you “must be in a state of control” at all times.
My SPI System allows you to meet the state-of-the-market requirements for transparency and traceability. Please check out my www.SystemsProcessingIntegration.com web site and let’s talk about what parts of the SPI System you can start to implement first.