A proposal that would have drastically limited access to food supplements to consumers in the US state of Arizona has been changed after the intervention of the Natural Products Association (NPA) and the American Herbal Products Association (AHPA).
The proposal under consideration by the Arizona Board of Pharmacy would have required companies to obtain a permit to market nutritional supplements like a “drug” and be subject to some of the requirements for nonprescription drugs in that state.
Unlike nonprescription drugs, natural supplement products are regulated as foods and are regulated differently by the US Food and Drug Administration (FDA).
“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.
“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.”
During a December 5, 2018 meeting the Arizona Board of Pharmacy 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 say they support “prompt and consistent enforcement by these Federal agencies against marketers who make unlawful disease claims”.
Arizona’s proposal to dramatically tighten regulation of food supplements came to light in September 2018 when specialist attorney Marc Ullman was preparing legal paperwork on behalf of a client in the natural products industry. In an interview, says that it quickly became “obvious that the state was looking at regulation of supplements in a different way than DSHEA [Dietary Supplement Health and Education Act of 1994] envisioned”, describing Arizona’s proposal as a “potentially enormous problem” for the supplements industry. He added: “The permitting would have required supplement companies to comply with, among other things, drug GMPs [good manufacturing practices].”