Over the summer, attorney Marc Ullman began reviewing paperwork on behalf of a client in the dietary supplement industry who was going through a permit and registration process with the Arizona State Board of Pharmacy.
“When we finally had an opportunity to look at the forms, it was 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,” revealed Ullman, of counsel to Rivkin Radler LLP, in an interview.
At that point, the lawyer said he identified “a potentially enormous problem” that could have ramifications for the dietary supplement industry in Arizona far beyond just his client.
“The permitting would have required supplement companies to comply with, among other things, drug GMPs [good manufacturing practices],” he said.
Ullman and industry trade groups expressed concerns that Arizona officials were seeking to impose burdensome requirements on dietary supplement companies that conflicted with federal regulations.
“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," Michael McGuffin, president of the American Herbal Products Association (AHPA), who wrote a letter in September to the Arizona State Board of Pharmacy, said Wednesday in a statement.
During a Dec. 6 public meeting, the Arizona State Board of Pharmacy made the decision to eliminate a longstanding regulation over dietary supplements, addressing the industry’s concerns. Kam Gandhi, PharmD, executive director of the pharmacy board, suggested during the meeting that it’s “almost redundant” for his board to oversee supplements since FDA regulates them.
“The governor’s office is fully in support of us deregulating that,” he said during the meeting.
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.”
In a follow-up interview, Gandhi said the pharmacy board moved to “redline” or repeal the regulation— R4-23-801, incorporated in Arizona's administrative code—so it “no longer has jurisdiction over dietary supplements,” with a limited exception.
“First of all, we’re one of the few states that did regulate dietary supplements and OTCs (over the counter drugs),” he said. “FDA has that covered, so we didn’t feel that we needed to be redundant, and we’ll let the FDA manage that part of the equation.”
‘FDA has more than adequate authority’
Speaking briefly in person during the Dec. 6 hearing, the leader of the Natural Products Association (NPA), Daniel Fabricant, Ph.D., commended “Gandhi’s decision to move ahead with deregulating.”
“FDA has more than adequate authority” over supplements, said Fabricant, who also pointed out FTC regulates advertising claims. “If there are specific problems with companies, please let us know. We also have self-regulatory issues we turn over to FDA (and) FTC frequently.”
Ingrid Lebert, senior director of government relations with the Council for Responsible Nutrition (CRN), said she was in regular contact with Gandhi via email and learned before the Dec. 6 meeting that the dispute was going to be successfully resolved.
CRN worked to verify the pharmacy board understood “how dietary supplements fall under the purview of FDA and FTC and how it doesn’t relate to OTC or OTC requirements,” she said in an interview.
Lebert added, “We support the Arizona Board of Pharmacy’s decision to remove language that might provide some dissonance between federal law and state law and everything in between.”
The Himalaya Drug Company
McGuffin’s letter to the Arizona State Board of Pharmacy suggested The Himalaya Drug Company triggered the dispute over the state’s regulation of dietary supplements.
“AHPA understands that Himalaya Drug Company submitted an application to the board for a permit as a nonresident wholesaler of nonprescription drugs and has now requested this application be withdrawn as erroneously submitted,” McGuffin wrote. “AHPA agrees that this application should not have been submitted, since Himalaya does not, in fact, distribute any nonprescription drugs as defined under federal or Arizona state laws, and therefore requests the board accept Himalaya’s request to withdraw its application.”
Ullman represented The Himalaya Drug Company, a marketer of Ayurvedic herbal dietary supplements.
In an emailed statement provided by Ullman, the company expressed gratitude to AHPA and NPA “for their assistance in dealing with and resolving the challenge to the dietary supplement trade presented by the Arizona Board of Pharmacy’s interpretation of state law in a manner that directly contradicted the protections provided by DSHEA.”
The two trade organizations, in working closely with Ullman, demonstrated FDA “already fully regulated” the company’s products, the statement added, “and there was no need” for the board to intervene.
“We greatly appreciate the board’s decision to rescind its regulations governing dietary supplements in recognition of FDA’s authority,” The Himalaya Drug Company concluded.
Dispute over medical claims
When asked what started the conversation in recent months over dietary supplements, Gandhi suggested his staff had identified medical claims on products.
“We inspect retailers and anybody that’s selling anything that’s deemed OTC or prescription drugs,” he said. “When my inspector’s out there reviewing what’s on the shelf, and she identifies a dietary supplement that has a medical claim like ‘helps your immune system’ … there’s an inference to a medical claim.”
He added, “We would contact … whoever’s making this thing and say, ‘Hey, you need to be permitted by us because you have an inference of a medical claim.’ That’s where the conversation started.”
Ullman said Arizona didn’t recognize dietary supplement claims authorized by federal law and treated them as drug claims.
“And that’s where the conflict of DSHEA came in,” he explained.
Repeal of regulation
In the interview, Gandhi said he anticipated the dietary supplement regulation will be repealed within the next three to four months. First, there will be an opportunity for public comment after a docket is opened with the Arizona Secretary of State, which he suggested could occur in about a month. Proposed rules are published in the Administrative Register, which is published by the Secretary of State’s Administrative Rules Division.
If the public doesn’t oppose the language, it moves to the Arizona Governor’s Regulatory Review Council, and once approved by that entity, the new rule gets published within weeks, Gandhi said.
AHPA, CRN and NPA all intend to file comments.
Gandhi cited a narrow exception to his proposal. Manufacturers of dietary supplements requesting a “certificate of free sale” to sell products internationally would be subject to inspection for GMPs and need to be permitted as a manufacturer.
“We don’t certify the product,” he explained. “We certify the process as [following] good manufacturing practices.”
When advised by a reporter that FDA may issue certificates of free sale, Gandhi said he understood companies are requesting such a document from the pharmacy board. (FDA stated in a guidance document that it issues export certificates, including a certificate of free sale, which is "for food, including dietary supplements, and cosmetic products that may be legally marketed in the United States").
“If they want to go to the FDA and get a certificate of free sale, they don’t have to be permitted by us,” Gandhi responded.
Gratitude to trade groups
Finally, Ullman said he was grateful to AHPA and NPA for their assistance, and that without it, the intended result likely would have come at a steep cost: “hundreds of thousands of dollars on very complex federal litigation” over such legal issues as federal preemption of state law.
“Supplements are not drugs and should not be regulated like drugs,” Fabricant said this week in a statement in a joint press release issued by AHPA and NPA, “because it would raise costs and block access to the products consumers want.”