FDA officials agree with the homeopathic industry on its products’ strong safety record, but the agency might not be convinced that the drug category’s history is enough to justify continuing its current policy that defers regulation largely to the industry.

At the opening of a two-day public hearing on April 20 for comment on FDA’s homeopathic product oversight, Center for Drug Evaluation and Research Director Janet Woodcock said the current regulatory framework limits the agency’s direct enforcement on homeopathics to post-market surveillance.

FDA has the same regulatory authority over homeopathic products it does for other forms of Rx and OTC drugs under a 1988 Compliance Policy Guide that recognizes an ingredient’s inclusion in the Homeopathic Pharmacopeia of the United States’ monograph as pre-market approval. The CPG does not exempt homeopathics from quality standards or from good manufacturing practices requirements, but shifts oversight of those to HPUS.

“FDA has clear regulatory authority over these products, however under our Compliance Policy Guide, we basically are mainly looking at instances where there are reports of harm or other reports when we regulate these products,” Woodcock said at FDA’s White Oak headquarters campus in Silver Spring, Md.

Woodcock said OTC access to the products is the source of some of FDA’s concern. She noted, as CDER did in its Federal Register notice announcing the hearing, that sales of homeopathics have grown substantially since FDA in 1972, at the start of its OTC drug review, deferred consideration of a separate regulatory framework for homeopathic ingredients.

“The majority of drug products that are labeled as homeopathic are marketed and sold directly to the consumer through magazines, the internet and in both big box retailers and traditional pharmacy retail outlets,” she said.

“This public hearing we hope will allow FDA to obtain information about these products and better protect public health, which is what we do, our mission,” the CDER director added.

Questions from members of the hearing panel, including Theresa Michele, director of CDER’s Division of Nonprescription Drug Products, Elaine Lippman, regulatory counsel in the center’s Office of Regulatory Policy, and Robert Nelson, deputy director and senior pediatric ethicist in the commissioner’s Office of Pediatric Therapeutics, for stakeholders most commonly addressed clinical trials for homeopathic ingredients, product labeling and whether the products should be available on the same retail shelves as conventional OTC drugs.

Safety Speaks For Itself

Each industry stakeholder – representing manufacturers, research and professional organizations and trade groups – speaking at the hearing emphasized the safety of Rx and OTC homeopathic drugs, though several said they support requiring additional information on product labels to better identify ingredients.

Stakeholders acknowledged that a component of the products’ safety is that an ingredient might have no efficacy on a consumer.

Marcel Fraix, a homeopathy physician and faculty member at the Western University of Health Sciences’ College of Osteopathic Medicine, said his patients understand the ingredients might not have an effect.

“The biggest risk patients understand is that it may not do anything at all, if you want to call that a risk,” he said during the first day of presentations.

While FDA officials express concern about whether consumers understand what homeopathics are and are adequately informed by labeling, they might want to consider how much consumers know about conventional OTC drugs, suggested M’Lou Arnett, CEO of [Matrixx Initiatives Inc.]

Asked by a panel member about the adequacy of homeopathics’ labeling, Arnett said, “I don’t know that the consumer is really that focused on how it purports to work or not.”

She offered an example of OTC H2 antagonists and proton-pump inhibitors indicated for indigestion and heartburn. “Consumers have indigestion so they go and see what is available to them OTC and they make a choice.”

“If it works for them, they’ll go back again. I’m pretty sure most consumers, unless they’ve had an in-depth conversation with their doctor, would not be able to tell us the difference between an H2 antagonist and a proton pump inhibitor,” Arnett said.

“The Compliance Policy Guide has served FDA and consumers well,” she said.

Bruce Shelton, a physician, homeopathy practitioner and president of the Arizona Homeopathic and Integrative Medical Association, said FDA’s consideration of potential changes has caused alarm in the industry and among consumers, but no changes are needed.

“The U.S. public health is correctly, adequately protected” under the CPG, Shelton said, adding that FDA “has substantial regulatory authority” to prevent homeopathics with Rx ingredients from being marketed OTC.

Amy Rothenberg, a member of the American Association of Naturopathic Physicians board, said considering label improvements a key issue, particularly to prevent products that contain other types of active ingredients, such as dietary supplements, from bearing a homeopathic label. Labeling “is at the heart of this whole hearing,” she said.

“If something has a lot of different things in it … it’s not homeopathy,” Rothenberg added.

History Supports Future

Three proponents for sustaining the CPG influenced FDA’s decisions either on a separate homeopathics review or establishing the current regulatory approach in 1988.

The Homeopathic Pharmacopoeia Convention of the United States’s general counsel, Gary Yingling, was an FDA assistant counsel and was part of the agency’s 1972 decision to defer a separate review of homeopathic drug regulations.

“I never heard any question about” deferring the agency’s review of homeopathics, Yingling said during a presentation for HPCUS.

Yingling pointed out that since the Food, Drug & Cosmetic Act’s passage in 1938, as well as in earlier legislation Congress did not pass, it has identified the HPUS monograph as a reference for homeopathic products.

“There’s a long and thoughtful history on the regulation of homeopathic drugs in the United States,” he said during the second day of the hearing.

Speaking the same day was attorney Alvin Lorman, who represented the industry in discussions with FDA that led to the homeopathy CPG. Lorman said some of FDA’s concern about the product category could be a result of an erosion of the industry-agency “very cooperative working relationship” that was a hallmark of some 15 years of working under the CPG.

Restoring a high level of cooperation appears more likely as a solution for any FDA concerns about homeopathics because the agency is unlikely to launch review of the category, he added.

“The OTC drug review … is far from over and we have little reason to expect that a separate OTC review for homeopathic drugs is somewhere on the horizon,” said Lorman, whose practice is in Washington.

“The real question is how much time and energy the agency is willing to devote to examining these drugs.”

Former FDA regulatory official Daniel Michels, calling himself “the person who was there when [the CPG] happened” and making the hearing’s final presentation, described agency thinking about homeopathics predominant not only when the CPG was established but also currently.

“We didn’t know what these products were. Nobody knew, no expertise in-house,” said Michels, director of the drug center’s Office of Compliance in 1988. “We were dealing with a different world” because homeopathics did not have trial histories similar to other drug types, he said.

Like Lorman, Michels, who is retired from working as a consultant after leaving FDA, recommended agency-industry cooperation to improve regulatory practices under the current CPG. “To the extent that there are changes appropriate … let’s be careful and work together,” he said.

“It is a less than perfect document but it is the best that we could do at that time,” he said of the CPG.

Drug Oversight By FDA Needed

Proponents for homeopathic pre-market review speaking at the hearing disagree with industry stakeholders that the possibility of an ingredient having no effect is a safety characteristic and argue that with labeling requirements imposed by FDA, consumers would know more about the products.

“It is not safe to have mislabeled drug products on store shelves,” said Adriane Fugh‐Berman, a Georgetown University Medical Center professor of pharmacology and physiology.

Fugh-Berman, who also worked for National Institutes of Health’s alternative medicine office and consulted with the Federal Trade Commission on dietary supplements, suggested FDA require labeling in a nomenclature similar to formats required for other Rx and OTC drugs with information on dosing and ingredients stated in common terms.

FDA also should enforce against homeopathics making unsubstantiated drug claims, similar to its activity in the supplement industry, she added. “They’re not even regulated to the extent that dietary supplements are regulated.”

Michael DeDora, of the Center for Inquiry, which asked FDA in a 2012 citizen petition to initiate a rulemaking to require the products meet standards of effectiveness set for nonprescription pharmaceuticals, pointed out the National Center for Complementary and Integrative Health’s website states, “there’s little evidence to support homeopathy as an effective treatment for any specific condition.”

DeDora, director of the Center for Inquiry’s Office of Public Policy, also criticized the argument sometimes made that even if a homeopathic remedy is ineffective, the product will not cause harm.

“This should deeply concern the agency charged with protecting the public health especially since the problem is caused in part by [FDA’s] failure to regulate homeopathic products,” he said.

The hearing launched CDER’s review of homeopathic drug regulations separate from the agency’s ongoing OTC drug review. FDA is accepting comments through June 22, to docket FDA-2015-N-0540, and has not stated when it will decide whether changes are needed Also see "GNC, Rite Aid expansion plans" - Pink Sheet, 13 August, 2007..

(Editor’s note: Look for additional coverage from the two-day hearing in the May 4 issue of “The Tan Sheet.)

FDA Examination Of Homeopathic Regulation Looks Beyond Safety History

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