Ullman, Trade Associations Score Big Win in Arizona

January 2, 2019 | Compliance Investigations & White Collar

On behalf of a client, Marc Ullman helped secure a decision by the Arizona State Board of Pharmacy to withdraw its attempt to regulate the dietary supplement industry at the state level.

The matter arose when the client, a dietary supplement distributor, received the Board’s demand that it register with the state as a Non-Resident Non-Prescription drug distributor or risk significant fines being levied against its retail customers.

Upon reviewing the Board’s application, Ullman realized that compliance with the relevant state regulations for non-prescription drug distributors would force the client out of compliance with federal regulations governing dietary supplements and could potentially create a risk of non-compliance with Federal Trade Commission requirements for product substantiation.

Working with the American Herbal Products Association (AHPA) and the Natural Products Association (NPA), and testifying before the Board on two occasions, Ullman played a major role in persuading the Board to withdraw its regulations that conflict with federal law.

This decision solved a number of serious questions relating to the conflict between federal and state regulation of dietary supplements. Left unresolved, the questions could have led to complex litigation implicating the Commerce and Supremacy Clauses of the U.S. Constitution.

The Board plans on publishing public notice of its intent to withdraw these regulations in early 2019.  Rivkin, AHPA and NPA plan on submitting comments in support of the action. The regulations’ removal should follow thereafter.

Natural Products Insider reported on this decision on December 20, 2018. To read the article, click here.

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