After Years of Diluted Enforcement, FDA is Giving Homeopathic Products a Closer Examination

Since 1988, FDA has allowed the marketing of homeopathic drug products for over-the-counter (OTC) use without new drug approval or compliance with an OTC monograph and without adherence to many of the OTC drug labeling requirements.  On March 27, 2015, FDA signaled that it may be reconsidering this policy.  FDA has scheduled a public hearing for April 20 and 21, 2015, entitled “Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century.”  This announcement comes on the heels of a March 19, 2015, consumer warning about potential health risks of OTC asthma products labeled as homeopathic and a March 2015 information paper issued by the Australian National Health and Medical Research Council concluding that “there are no health conditions for which there is reliable evidence that homeopathy is effective.”

We also note that class action activity has picked up in this area as well.  In one recent case, there was a $5 million settlement by Boiron Inc., not including costs of relabeling and legal fees, with a commitment to a label disclaimer stating uses have not been evaluated by FDA and providing an explanation of dilution.  Gallucci v. Boiron, Inc., 3:11-cv-02039-JAH-NLS (S.D.Cal.).  This settlement was affirmed by the 9th Circuit on February 24, 2015.  A number of other cases are also currently pending, including an action against Whole Foods alleging that its 365-brand cough syrup and remedies are so diluted that they have no effect on the human body and don’t effectively treat flu-like symptoms in adults and children.  Herazo v. Whole Foods Market, 0:14-cv-61909 (S.D. Fla.) (Aug. 21, 2014).

The practice of homeopathy is based on the belief that disease symptoms can be cured by small doses of substances that produce similar symptoms in healthy people.  In 1988, FDA issued a compliance policy guide (CPG) that delineated the conditions under which homeopathic drugs may ordinarily be marketed in the United States.  Conditions Under Which Homeopathic Drugs May Be Marketed, Compliance Policy Guide § 400.400.  Although FDA takes the position that the new drug definition and the requirement for new drug approval apply to homeopathic drugs, it has exercised its discretion not to enforce these provisions and certain labeling requirements against homeopathic drugs recognized in the Homeopathic Pharmacopeia of the United States (HPUS) and meeting other conditions set forth in the CPG.  The Federal Food, Drug, and Cosmetic Act (FFDCA) recognizes as drug products substances listed in the HPUS and specifies that homeopathic drugs generally must meet the standards for strength, quality, and purity set forth in the HPUS. FFDCA §§ 201(g)(1), 501(b).  Sen. Royal Copeland of New York, a homeopathic physician, was responsible for the inclusion, and legitimization, of homeopathic remedies in the FFDCA when it became law in 1938.

Under FDA’s CPG, a homeopathic drug must be labeled for homeopathic use and contain only active ingredients listed in the HPUS at potencies specified in terms of dilution (e.g., 1X (1/10 dilution), 2X (1/100 dilution), etc.) and diluents commonly used in homeopathic pharmaceutics, such as water and alcohol.  Homeopathic products marketed OTC must be intended solely for “self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment.”  Although FDA has not expressly exempted homeopathic drugs from the Drug Facts labeling requirements, it nevertheless stated that homeopathic products “ordinarily will not be recommended for regulatory action if the product is a homeopathic drug as described in [the CPG] and the product follows the labeling and all other recommendations outlined in that guidance document.”  64 Fed. Reg. 13254, 13258 (Mar. 17, 1999).  FDA has issued a number of warning letters over the years citing OTC products marketed as homeopathic that fail to meet the CPG’s requirements (e.g., marketed for indications that are not self-limiting disease conditions amenable to self-diagnosis or containing non-homeopathic ingredients).

In 1972, FDA excluded homeopathic drugs from the OTC Review “[b]ecause of the uniqueness of homeopathic medicine,” indicating that it would “review them as a separate category at a later time after the present OTC drug review is complete.”  37 Fed. Reg. 9464 (May 11, 1972).  This has not yet occurred, and, in the 17 years since the CPG was first issued, the popularity of homeopathic products, which had once served the needs of a relatively small niche of licensed practitioners, has increased exponentially.  Indeed, in its public meeting notice, FDA observed that recent estimates indicate the adults are spending upwards of $2.9 billion on the purchase of homeopathic products annually. Whether this recent announcement will reignite what has been characterized as a “war between conventional and alternative medicine” will be disclosed in the record of this proceeding.  N. Robins, Copeland’s Cure: Homeopathy and the War Between Conventional and Alternative Medicine (Deckle Edge, 2005).

The Agency’s recent public meeting announcement expressed concern about the safety of drug products labeled as homeopathic.  It is seeking comment, both in oral presentations and written submissions, on the following topics:

  • What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?
  • What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?
  • Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.
  • Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
  • Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?
  • A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?
  • Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?
  • Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?

Written comments can be filed electronically at (FDA-2015-N-0540) until June 22, 2015.*  To make an oral presentation during the hearing, you must register with FDA by April 13, 2015.

* The comment period to this docket has been extended to August 21, 2015

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