Registration requirement for dietary supplements in Arizona causes stir

The Arizona State Board of Pharmacy has begun interpreting its authority in a way that implies practically every manufacturer and marketer of dietary supplements in the state must register as a nonprescription drug facility, the American Herbal Products Association (AHPA) said this week.

“If the board is successful and persistent in this approach,” the trade organization cautioned Wednesday in an emailed update, “it could significantly disrupt dietary supplement business in the state.”

According to a position conveyed by the state pharmacy board, companies selling dietary supplements in Arizona must register as either a resident or nonresident “wholesaler of nonprescription drugs” if any of their supplements provide statements of nutritional support authorized by the Dietary Supplement Health and Education Act of 1994 (DSHEA), AHPA said.

“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,” the update continued. “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.’”

In an interview, Kam Gandhi, PharmD, executive director of the Arizona State Board of Pharmacy, said concerns expressed by individuals selling dietary supplements relate to a rule on the books for years: R4-23-801, incorporated in Arizona's administrative code.

“A lot of folks that really didn’t realize this was in existence are frustrated,” Gandhi acknowledged. “But folks [who] have been compliant, it hasn’t been an issue.”

The rule, which took effect in 2003, asserts the following: “A person who sells, distributes, or provides a product that is labeled as a dietary supplement and is labeled or marketed as a treatment for any deficiency disease, for the correction of any symptom of disease, or for the prevention, mitigation, or cure of any disease, either by direct statement or by inference, is selling, distributing, or providing a drug and is subject to the requirements of A.R.S. [Arizona Revised Statute] Title 32, Chapter 18 and 4 A.A.C. 23.”

The state statute above—otherwise known as the Arizona Pharmacy Act—governs such matters as the state pharmacy board, as well as licensure and permits related to drugs.

Per DSHEA, marketers of dietary supplements cannot claim to cure, diagnose, mitigate, treat or prevent a disease, although the law did authorize statements claiming a benefit related to a nutrient deficiency disease.

“If you are a dietary supplement and you have claims saying, ‘Hey, this cures a cold’ or ‘this helps healing,’ ‘this helps stress’—the medical condition—if you combine a dietary supplement [with] a claim, then you’re going to be deemed as … an OTC (over the counter) drug,” Gandhi said.

It is possible disagreements could arise over whether statements made by supplement companies meet the criteria in Arizona’s rule or fall outside it.

Asked for other examples that would meet the criteria in Arizona’s rule, Gandhi mentioned supplements marketed to help a person relax, assist with aches and pains, and help with such cognitive function as memory loss and memory gain.

Under DSHEA, companies are authorized to make a claim for a dietary supplement, provided certain conditions are satisfied, if “the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.”

Asked by a reporter whether he viewed a conflict between the state pharmacy board’s interpretation of state law and federal law, Gandhi responded: “That’s going to be up to the board’s determination.”

Per federal law, companies that manufacture, pack, label or hold (except retail) dietary supplement products, AHPA noted, must register as food facilities with FDA. Federal law, however, doesn’t impose specific permitting requirements on dietary supplements. Marketers, for example, don’t need a permit from FDA before selling their products in interstate commerce.

Gandhi cited an argument he’s heard that “the federal government is OK with us being a dietary supplement, and they don’t require us to be permitted, so why do you?”

But earlier in the interview, he said the states are free to impose stricter requirements than under federal law. “Federal [law] is the baseline, and if the state wants to have a stricter law as far as needing somebody permitted, that’s the state’s jurisdiction to do so,” he said.

Gandhi said there are dietary supplement companies registered with the state pharmacy board, though he could not immediately specify the number.

The state pharmacy board is scheduled to further discuss the issues above during a public meeting on Dec. 5. According to its website, the board's mission is to protect "the health, safety and welfare of the citizens of Arizona by regulating the practice of pharmacy and the manufacturing, distribution, sale and storage of prescription medications and devices and non-prescription medications."

Asked if the state pharmacy board is moving to be more vigorous in its enforcement of its rule, Gandhi said, “My board is looking to be fair with everybody.”

In a letter dated Sept. 24, AHPA challenged the state pharmacy board’s interpretation of the Arizona Pharmacy Act. The trade association said a registration requirement would impose substantial new burdens on the dietary supplement industry and create obligations that companies based outside Arizona couldn’t meet, including a requirement to hold an equivalent nonprescription drug wholesale license or permit in the jurisdiction where the business resides.

“These requirements set up an impossible situation for dietary supplement companies located outside of Arizona,” AHPA President Michael McGuffin wrote in the letter addressed to board members of the Arizona State Board of Pharmacy. “Because these products are not nonprescription drugs, there is no reason for these firms to possess a license or permit issued by the state in which they reside that is equivalent to Arizona’s nonprescription drug permit, and to the best of AHPA’s knowledge, there is no other state that issues such a license or permit.”