Virginia (202) 466-6937 | Arizona (602) 388-8899

The Uncoupling of Injury from Adulteration

The pyridoxamine example, well explained by Bethany in her blog post, proves the inherent pitfalls in 21 USC 321(ff)(3)(A)-(B).  As we have seen, the new interpretation given by FDA to the term “New Dietary Ingredient,” the FDA’s redefinition of adulteration standards through its Good Manufacturing Practice Guidelines, and the changes effected by the Food Safety […]

The Pyridoxamine Trap

When evaluating whether an ingredient can be used in a dietary supplement, one must assess not only whether the ingredient is a new dietary ingredient (“NDI”), i.e., “a dietary ingredient that was not marketed in the United States before October 15, 1994,”  21 U.S.C.  § 350b(d), but also whether prior to its sale as a dietary […]

FDA to Supplement Manufacturers: Confirm Safety of Direct Food Additive or GRAS NDIs

FDA recommends that dietary supplement manufacturers and distributors voluntarily consult with it concerning the safety of supplements containing high amounts of new dietary ingredients (“NDIs”) that are approved direct food additives or GRAS. An NDI notification must be submitted to FDA at least 75 days before selling a dietary supplement if the dietary supplement contains […]

ANH Comment: FDA NDI Guidance Imposes Substantial Economic Burdens

On Tuesday, August 2, 2011, Emord & Associates filed comments with the FDA and Office of Management and Budget (OMB) concerning the FDA’s proposed collection of information through 75-day New Dietary Ingredient notifications.  We previously reported on the FDA’s proposed New Dietary Ingredient (NDI) guidance here and here. Federal agencies frequently collect information from private […]

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Virginia (Firm HQ)

11808 Wolf Run Lane
Clifton, VA 20124
Telephone: (202) 466-6937
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2730 S. Val. Vista Dr.
Bldg. 6, Ste 133
Gilbert, AZ 85295
Telephone: (602) 388-8899
Telecopier: (602) 393-4361