by Joel Rothman | Dec 13, 2008 | NutriSupLaw
Although Section 403(y) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 343(y), does not require a dietary supplement label to include anything other than a domestic address or phone number for the responsible person, the FDA recommends that the...
by Joel Rothman | Sep 5, 2008 | NutriSupLaw
CFSAN issued this press release recently that announces the publication in the Federal Register of a notice (73 FR 43937; July 29, 2008) requesting comment on Section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Here is FDA’s summary...
by Joel Rothman | Jun 10, 2008 | NutriSupLaw
The American Herbal Products Association (AHPA) has requested that FDA clarify its policy on products combining over-the-counter drugs and dietary supplement ingredients. To read the letter from AHPA to FDA, click here. According to this article in Natural Products...
by Joel Rothman | Apr 26, 2008 | NutriSupLaw
Your editor, dietary supplement regulatory attorney Joel Rothman, and seasoned supplement industry regulatory consultant Vincent Annunziata, in cooperation with the law firm of Seiden, Alder, Matthewman & Bloch, P.A., have announced the formation of a new FDA...
by Joel Rothman | Apr 26, 2008 | NutriSupLaw
Your editor here at Nutrisuplaw.com and regulatory consultant Vincent Annunziata are quoted in a new article in ICIS Chemical Business on the new cGMP regulations for dietary supplement companies. To read the article, click here.