Thursday, January 13, 2005

01/13/05 - Structure and Function Claims Review


Happy new year! It’s time for your annual Nutrient Claims check-up!

The FDA continues to increase enforcement of its regulation of Dietary Supplements. In a recent Warning Letter to one vitamin company, for example, it found that the following statements were “drug claims:” "Nature’s answer to prescription medication" and "Nature’s alternative to prescription medication." The FDA also cited phrases such as, “seems effective in . . . reducing depression . . . ." In another recent warning letter, the FDA complained against the phrase, “the number one remedy against obesity.”

In yet another warning letter, Neutraceutica was told that its claim, “possibility of cancer and other diseases may be eliminated in the first days of the use” was an unproven drug claim. This is one time when I find myself agreeing with the FDA.

Staying up to date with changes in the law is also important. For example, a little known clause in the Farm Security and Rural Investment Act amended the Food and Drug Act to provide that the term “ginseng” can be used only for derivatives of the genus Panax, not the genus Eleutherococcus (though both are commonly known as “ginseng”).

What changes have you made in your web site during the past year that may put you at risk? If you have added new claims, have you notified the FDA of the new structure and function claims?

Now’s the time (while I’m snowed in here in the hills of Sussex NJ) for us to catch up on these necessary aspects of your legal needs. Please give me a call at 973-300-1519 so we can discuss your needs. These issues can be critical – and expensive -- for your company, if not addressed in a timely manner. That’s why I’ve sent you this email to remind you it is time for your annual FDA/FTC compliance check-up.

Ralph Fucetola JD

PS – if you need help in creatively constructing structure and function claims, let me know. In the first example above, “the number one remedy against obesity” the company could have stated, “a leading supplement to support normal weight…” As always, clients on regular retainers are guaranteed no increase in fee rates and may qualify for the Vitamin Lawyer Oversight Seal (see for details).