FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry stakeholders regarding its current regulatory framework for homeopathic drug products, the agency has issued a draft guidance proposing a new, risk-based enforcement approach for drug products labeled as homeopathic.  Following the public hearing, FDA received more than 9,000 comments in response to its request for “broad public feedback on its enforcement policies related to drug products labeled as homeopathic.”[1]

According to FDA, after considering the information obtained from the public hearing, as well as the comments submitted to the public docket, it determined that

it is in the best interest of the public health to issue a new draft guidance that proposes a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without FDA approval.[2]

While the draft guidance provides a risk-based enforcement framework for products labeled as homeopathic, it leaves open the question as to how the agency will address the marketing of homeopathic drug products in the future considering that the draft guidance, when finalized, will withdraw FDA Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed,[3] which was issued by the agency in 1988.

In the draft guidance, the agency states that homeopathic drugs are subject to the same regulatory requirements as other drugs,[4] and as such, a homeopathic drug would be considered to be a “new drug” if “it is not generally recognized as safe and effective (GRAS/E) by qualified experts for use under the conditions prescribed, recommended, or suggested in the labeling (section 201(p) of the [Federal Food, Drug, and Cosmetic Act (FD&C Act)] (21 U.S.C. 321(p)).[5]” The FDA makes GRAS/E determinations for over-the-counter (OTC) drugs under the OTC drug review.[6] However, when establishing the OTC drug review process in 1972, FDA determined that homeopathic drug products were a separate category of products and deferred consideration. To date, the FDA has not evaluated any homeopathic drug ingredient under the OTC drug review.

As such, as noted by FDA, “absent a determination that a drug product labeled as homeopathic is not a ‘new drug’ under section 201(p), all drug products labeled as homeopathic are subject to the premarket approval requirements in section 505 of the FD&C Act . . . .” Currently, there are no homeopathic drug products that have been approved by FDA. Based on the above, FDA would not consider any homeopathic drug product (OTC or prescription) to be “legally” marketed at this time.

As stated in the draft guidance, FDA is providing notice that any product labeled as homeopathic that is being marketed illegally (e.g., not subject to a New Drug Application (NDA) or OTC Drug Review) is subject to FDA enforcement action at any time. Thus, the draft guidance is only outlining how the agency will prioritize enforcement against homeopathic drugs being marketed in the United States without the required FDA approval. This means that any product on the market may be subject to enforcement action at some point unless it obtains the necessary approval. At this time, however, FDA is not providing any guidance as to what, if anything, can be done by industry to legally market these products, short of submitting an application for approval.

The following is a listing of the categories of products that FDA intends to prioritize enforcement and regulatory actions because they potentially pose higher risk to the public health:

  • Products with reported safety concerns;
  • Products that contain or purport to contain ingredients associated with potentially significant safety concerns (e.g., belladonna);
  • Products for routes of administration other than oral and topical (e.g., injectable products);
  • Products intended to be used for the prevention or treatment of serious and/or life threating disease and conditions (e.g., cancer);
  • Products for vulnerable populations (e.g. children);
  • Products deemed adulterated under section 501 of the FD&C Act (e.g., product does not meet standards for quality, strength or purity under the law).

Under this approach, FDA recognizes that “many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers[7].” Thus, consumers should still have access to a large majority of OTC homeopathic drugs at least for the foreseeable future.

Comments to the draft guidance should be submitted to FDA on or before March 20, 2018. Any comments should be received by the deadline to ensure that they will be taken into consideration before FDA finalizes the draft guidance.

[1] See FDA’s News Release entitled “FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs,” available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm (December 18, 2017).

[2] Id.

[3] CPG 400.400 outlines conditions (e.g., labeling, prescription status, current good manufacturing practices) under which homeopathic drug products may be marketed.

[4] See Draft Guidance at 2.

[5] Id.

[6] The OTC drug review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. It is a three-phase public rulemaking process (each phase requiring a Federal Register publication) resulting in the establishment of standards (monographs or non-monographs) for an OTC therapeutic drug category. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069917.htm (last visited on December 21, 2017).

[7] See FDA’s News Release dated December 18, 2017.

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