Terra Sigillata

Be Careful Making “Drug” Claims…

Posted by Abel Pharmboy on October 16, 2007
(2)
More »

These aren’t the 1920s. If you want to get your remedy approved as a drug, you’ve got to abide by the rules everyone else plays by. From the FDA press release:

At FDA’s request, U.S. marshals have seized about $71,000 worth of products from Florida-based FulLife Natural Options Inc. after the agency determined that FulLife violated food and drug law by promoting certain products for use in treating serious conditions such as diabetes and high blood pressure. Because of the claims, FDA considers the products — Charantea Ampalaya Capsules and Charantea Ampalaya Tea — to be unapproved drugs.

Cluestick to unscrupulous manufacturers who make it bad for the reputable folks: stay away from chronic and potentially fatal diseases…and re-read the label claims section of DSHEA.

(2)
More »

Comments

  1. #1 syncopee
    October 16, 2007

    I don’t get it. These companies have virtually unregulated free reign in the supplement market with minimal overhead costs relative to a pharma co. Why would they jeopardize profits by making direct disease treatment claims?

  2. #2 DuWayne
    October 16, 2007

    This dovetails nicely with the article I emailed you.

    I live in Portland, at the heart of CAM country. I am working on an article that I hope to get published in a local paper here, that is sure to draw serious fire from CAM practitioners and instructors. Thanks for providing so much great info to help me get my ducks in a row on this topic.