Arizona pharmacy board backs down on plan to regulate supplements like OTC drugs
AHPA and NPA challenged a recent policy shift by the Arizona Board of Pharmacy that requires companies to obtain a permit to market nutritional supplements in the state. The permitting process subjects companies to some of the same requirements for nonprescription drugs in the state.
AHPA and NPA countered that dietary supplements have an excellent record of safety as a category, making an additional permitting process like Arizona’s unnecessary. And in any case, the supplements are already subject to regulation by the US Food and Drug Administration.
In the early fall, the board started communicating a position that companies selling dietary supplements in Arizona would be required to register as either a resident or nonresident "wholesaler of nonprescription drugs" if any of their supplement products provide DSHEA-authorized statements of nutritional support.
Policy apparently applied to all companies doing business in state
This new interpretation of the Arizona Pharmacy Act would apparently apply to all companies doing business in the state, whether located in Arizona or elsewhere.
If applied consistently, this interpretation could also require each supplement manufacturer to register as a “drug manufacturer,” and every retailer in Arizona that sells supplements to register as a “nonprescription drug retailer.”
During a meeting on Dec. 5, the state board began the process to eliminate the language from the Arizona Administrative Code and restricting the Arizona Board of Pharmacy’s jurisdiction over dietary supplements. Disease claims made by dietary supplement products will remain under the jurisdiction of the FDA and the FTC, and both NPA and AHPA support prompt and consistent enforcement by these Federal agencies against marketers who make unlawful disease claims.
“The state permit requirements as originally proposed would have been inconsistent with longstanding and extensive Federal dietary supplement regulations and would have put companies selling supplements in Arizona in an unreasonable position," said AHPA President Michael McGuffin. "AHPA thanks the Board for recognizing that supplements that make claims that are lawful under Federal regulation are not nonprescription drugs and cannot be regulated as drugs in Arizona.
“Natural products and supplements are safe and under strict regulation by the federal government, and because of that the U.S. enjoys the safest food supply in the world. Supplements are not drugs and should not be regulated like drugs, because it would raise costs and block access to the products consumers want. We commend the Arizona Board of Pharmacy and other officials for working with us to help Arizonans,” said Daniel Fabricant, President and CEO of NPA.
Changes to the Arizona Administrative code require a period of public notice and NPA and AHPA both said they plan to submit comments as part of that process.
