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NPA says that FDA’s stated goal to crack down on high-risk drugs labeled as homeopathic products is unnecessary given existing regulatory requirements and that the agency should go through formal rulemaking, not draft guidance, if it wishes to enact stricter regulations for homeopathics.
In comments submitted on March 20, 2018, to FDA regarding the agency’s December 2017 draft guidance on homeopathic products, the Natural Products Association (NPA; Washington, DC) argued that the guidance will reduce consumer choice in homeopathic products, raise prices on those products, and thus, hurt small businesses. NPA said that FDA’s stated goal in the draft guidance to crack down on high-risk drugs labeled as homeopathic products is unnecessary given existing regulatory requirements and that the agency should go through formal rulemaking, not draft guidance, if it wishes to enact stricter regulations for homeopathics.
Homeopathy refers to an alternative system of medicine developed in the late 1700s that had, until recently, enjoyed relative quiet on the regulatory front. Since 1938, Congress has stated that homeopathic remedies should be regulated by FDA in the same manner as non-prescription, over-the-counter (OTC) drugs. In 1988, FDA announced a new Compliance Policy Guide (CPG 400.400) for homeopathic drugs, titled “Conditions Under Which Homeopathic Drugs May Be Marketed,” which provides guidance on the regulation of OTC and prescription homeopathic drugs and describes “those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” The guide details provisions regarding labeling, packaging, ingredients, and good manufacturing practices for homeopathic products, with specific requirements delineated for prescription and OTC homeopathic drugs. This CPG is the outline by which FDA currently regulates homeopathic products.
Homeopathic products have become increasingly popular in recent years, and, per FDA’s draft guidance, are frequently mass manufactured and widely marketed as OTC. The growing popularity of these products has sparked the agency into taking a closer look at how these products are enforced. In September 2016, FDA issued a press release advising consumers to discontinue using homeopathic teething tablets and gels-an indication that the agency was stepping up enforcement in the homeopathic market.
The FTC has likewise begun to clamp down on regulation of homeopathic products. In November 2016, FTC released two guidance documents on how homeopathic products are marketed and advertised that substantially affected the way marketers could make product-benefit claims.
In December 2017, FDA released its draft guidance on homeopathic products. The new guidance, FDA said, was issued to provide notice that the agency will be taking a “risk-based approach” to prioritizing enforcement and regulatory actions involving homeopathic products.
Specifically, FDA said that it intends to prioritize enforcement involving drug products labeled as homeopathic and marketed without the required FDA approval including those that contain or claim to contain ingredients associated with safety concerns (including controlled substances or infectious agents, among others); products administered by means other than topical and oral; products intended for use for prevention or treatment of serious diseases and health conditions; products for vulnerable populations; and products deemed adulterated under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA also noted that in concurrence with the new draft guidance, it would be revoking the existing Compliance Policy Guide 400.400.
NPA’s comments are the latest in an ongoing conversation about how this new guidance affects the homeopathic category. In comments submitted to FDA, NPA asserted that FDA’s existing regulations for homeopathic products, as set forth under the CPG 400.400, are sufficient, and that there is no need for changes suggested in the guidance document.
Currently, said NPA, FDA already has the tools to remove harmful products, including homeopathic products, from store shelves. In addition, NPA said, FDA can take various administrative actions-for example, warning letters, seizures, and injunctions-against companies who introduce misbranded or adulterated homeopathics to the market. Further, FDA “can enlist states with embargo authorities. Claims that go beyond those permitted for conditions that are amenable to self-diagnosis and treatment by individuals who are not medical practitioners, FDA can charge them as unapproved new drugs and for committing a prohibited act through introduction or delivery of a misbranded or adulterated product into interstate commerce.” The FTC, meanwhile, has the authority to go after homeopathic products if it finds that the claims are unsubstantiated by scientific evidence.
Moreover, NPA said that most homeopathic products on the market today are adequately labeled, are safe and efficacious, and are backed by clinical research. In addition, the majority of OTC homeopathic drugs are in compliance with FDA and the Homeopathic Pharmacopoeia of the United States (HPUS) requirements, NPA said.
Because of this, NPA said, new or additional regulations are not required. Thus, in its comments, NPA asks that FDA use its existing enforcement authority to oversee the homeopathic drug category, and warned that the agency’s proposed changes could potentially create a three-year backlog of new products that have established records of safe use.
NPA also indicated that an attempt by FDA to implement changes to how homeopathic products are regulated via draft guidance would be an overreach of the agency’s authority. Said NPA: “Should this guidance be referenced by the agency in future enforcement activities, to effectively narrow the scope of a regulatory category in effect since 1972 such an event would appear to be at odds with the Administrative Procedures Act (APA), and more importantly the agency’s transparency initiative.”
Under the APA, NPA writes, notice-and-comment rulemaking is required whenever a federal agency wants to act in a way that “materially established burdens and benefits…which one would believe would accurately describe any enforcement activities against products which are currently meeting all regulatory requirements necessary to be lawfully marketed as homeopathic drugs but are determined to be unapproved drugs by the agency solely on the basis of not having the new homeopathic disclaimer statement or how the product is labeled or packaged.”
Daniel Fabricant, PhD, president, CEO, NPA, explained how the new guidance would impact consumers, manufacturers, and business, in a press statement from NPA: “This is another example of the FDA trying to make unnecessary changes to a process that has protected consumers for decades. Unfortunately, the end result is going to be less choices for consumers, higher prices, and more burdens on small businesses for no apparent health benefits. The FDA’s current enforcement policies are appropriate and sufficient to protect consumers, protect public health, and to ensure access to a wide array of homeopathic ingredients and products.”
Fabricant continued: “Where does the money come from to require companies to make new label changes on homeopathics and for the FDA to begin new enforcement, based upon new thinking in guidance? The FDA’s proposal to amend a process that has kept consumers safe for more than 25 years would create a three-year backlog for new products and ingredients, limiting access to safe and effective products consumers use and trust.” He added that, in the past, federal regulatory bodies have taken appropriate enforcement measures against adulterated and misbranded homeopathic products, “and we fully support future enforcement action under current law.”
In its comments to FDA, NPA reiterated its interest in partnering with FDA to improve the way the agency applies enforcement discretion, including developing guidelines for claims used to market OTC homeopathic products. NPA’s full comments can be viewed here.