OTC Homeopathic Market Could Shrink Under US FDA Risk-Based Oversight, Trade Groups Say

US FDA’s draft guidance for homeopathic products could result in consumer confusion, force sales of the products largely online and create a three-year backlog in review of products that have a safe track record, industry trade tells the agency. Agency plans to replace the existing compliance policy guide that largely delegated oversight to the Homeopathic Pharmacopeia of the US with risk-based enforcement by FDA.

US FDA’s draft guidance on OTC homeopathic products will confuse the industry, consumers and retailers and lead to the products being sold online only, the American Association of Homeopathy Pharmacists says in comments to the agency.

“Deleting the relative certainty in the current guidance would mean that many mass market sellers might find it difficult to decide which products they could and should sell,” said AAHP President Mark Land in comments on the draft submitted to FDA. “Reducing the sale of homeopathic drugs by established mass marketers would simply drive consumers, who clearly want these products, to online sellers who generally escape routine FDA inspection.”

AAHP's comments are on FDA’s December 2017 draft guidance creating a risk-based enforcement approach for homeopathic products similar to its oversight of conventional OTC and Rx drugs that are marketed following FDA evaluation or nonprescription products available under monographs. (Also see "US FDA Moves Homeopathic Drug Enforcement To Risk-Based Approach" - Pink Sheet, 18 Dec, 2017.)

Proposed enforcement criteria in FDA's draft guidance “are sufficiently vague that both enforcement and compliance will be compromised and become an area of uncertainty.” – American Association of Homeopathy Pharmacists President Mark Land

The draft guidance allows the products to remain available without pre-market approval but identifies problems the agency will target for enforcement. The list of problems where FDA will “prioritize enforcement and regulatory actions” includes routes of administration other than oral and topical or intended use for prevention or treatment of serious or life-threatening diseases and conditions.

The agency said when upon finalizing the guidance, it will withdraw the compliance policy guide it published in 1988 as its regulatory framework for the sector. The 1988 document defines the ingredients allowed for marketing in the US as those included in the Homeopathic Pharmacopeia of the United States’ monograph.

AAHP asks FDA to consider incorporating “some of the important” criteria of CPG not found elsewhere in agency guidance or regulations. Without those, the proposed criteria for enforcement action “are sufficiently vague that both enforcement and compliance will be compromised and become an area of uncertainty,” Land says.

AAHP: Combine CPG And Guidance

Land encourages FDA to combine the CPG with the draft guidance to allow enforcement flexibility while also providing enough detail for industry. He recommends including these components of the CPG in the guidance:

• require homeopathic active ingredients be from an approved Homeopathic Pharmacopoeia of the US monograph;
• prohibit combination of homeopathic and other active ingredients;
• list sources for traditional homeopathic use;
• identify active ingredients’ names in Latin;
• identify a product as homeopathic on principal display panel; require disclaimers on label;
• establish an FDA point of contact on homeopathic issues.

The CPG, he argues, has been an “effective enforcement tool” as evidenced by FDA asking firms to recall homeopathic drugs it considered non-compliant and issuing “numerous warning letters involving homeopathic drugs since 1990, when the 1988 guidance went into full effect.” He points out that warning letters have covered issues including labeling and good manufacturing practices.

AAHP separately changed its recommended label disclaimer in response to the Federal Trade Commission's increased scrutiny of  homeopathic ad claims (see sidebar).

NPA: Three-Year Backlog With New System

The Natural Products Association stated similar sentiments in its comments to FDA. NPA CEO and President Daniel Fabricant says FDA's current enforcement policy under the CPG is “appropriate and sufficient.”

Fabricant asks whether the agency has performed analysis to show that moving to a risk-based approach is “material” to effective oversight. He suggests FDA publish that information before publishing a final guidance.

Ending the CPG-based oversight is risky, Fabricant suggests, as it could lead to a pre-approval gatekeeper approach for homeopathic drugs. “If FDA regulates homeopathics with a pre-approval system, which has occurred in other countries, the pre-market authorization process here will be overwhelming. The United States will experience three-year backlogs for ingredients and products which have a safe track record. In turn, this will interfere with industry innovation and consumer access to those homeopathic products,” he predicted.

Without Homeopathic Definition, Imports Stall

AAHP also criticizes the draft guidance for identifying only the types of products that will attract FDA’s regulatory attention while providing little information on how companies comply. “AAHP supports a risk-based approach, but believes that the proposed guidance omits too much to be of any practical use to any party,” Land wrote.

For example, the draft guidance does not define “homeopathic,” he noted. “Since FDA said that the new policy would not affect most homeopathic products, the lack of a definition means that a marketer could label a product as homeopathic and so long as that product did not pose the kind of claimed safety risks which FDA said would attract its attention, it is unlikely that the product would be an FDA enforcement priority.”

The absence of a definition not only would confuse retailers and consumers but also create problems for importing homeopathic products to the US, AAHP contends. It suggests that FDA staff at US ports of entry, working without the CPG's specific guidance and taking a risk-based approach, likely will simply forward to agency headquarters questions about homeopathic products.

“Long experience with the Center for Drug Evaluation and Research shows that responding to internal questions about homeopathic products is a relatively low priority. While this may not create problems for a domestic homeopathic manufacturer, it creates the potential for considerable delay and expense for importers of homeopathic products, which must be cleared by FDA before they are released by US Customs and Border Patrol,” Land said.

Land also contends the draft guidance gives the impression that homeopathic products are being marketed illegally, suggesting that "was the clear message received and disseminated by the media.”

Instead, he says, FDA's failure to complete its OTC drug monograph in the "OTC Review" it started at Congress' direction in 1962 has left homeopathic regulation in limbo. The agency in 1972 deferred review of homeopathic drugs and planned to later review the products as a separate category before opting in in 1988 to publish the CPG that shifts oversight of homeopathics' quality standards and GMP requirements to HPUS.

“FDA’s failure to finish the OTC Review and to create a similar review for homeopathic drugs does not make homeopathic illegal. Using a proposed policy to give the impression that they are illegal is an abuse of agency discretion,” Land wrote.

Even excluding homeopathics, FDA has not completed its OTC monograph process as it largely has become untenable due to the notice-and-comment rulemaking required for making any change or addition. Legislation to overhaul the process, allowing FDA to make monograph decisions through administrative orders, allowing market exclusivity for some approval monograph proposals and establishing a user fee program to support the agency's work, has gained traction in Congress and has expectations to pass this year. (Also see "FDA Busy Sorting OTC Monograph Ingredients Anticipating System Overhaul " - Pink Sheet, 23 May, 2018.)

From the editors of the Tan Sheet.