by Stacy L. Ehrlich and Celeste D. Wheeler
On December 18, 2017, the U.S. Food and Drug Administration (FDA) issued its long-awaited Draft Guidance for Industry: Drug Products Labeled as Homeopathic (December 2017). As discussed in our March 2017 blog post, after FDA quietly added homeopathic drugs to its regulatory agenda without an explanation, the homeopathic industry was left wondering whether FDA planned to undertake a wholesale revision of its historical approach to the regulation of homeopathic drugs. The new draft guidance indicates that, while FDA is still not requiring all homeopathic drugs to be approved, it is certainly taking a new look at the category. Once the final guidance is issued, FDA plans to withdraw Compliance Policy Guide (CPG) 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (May 31, 1988), the document which has long guided manufacturers and distributors of drugs labeled as homeopathic. FDA’s past hands-off approach, which was recently brought into question by a few highly publicized incidents and by the Federal Trade Commission’s critique of FDA’s approach, was widely anticipated to be high on FDA’s priority list for reconsideration.
The draft guidance, which outlines FDA’s planned risk-based enforcement approach to the regulation of homeopathic drugs, states that any product that is being marketed illegally – which from FDA’s perspective could be any homeopathic drug that lacks approval – is subject to enforcement action at any time without notice. FDA plans to prioritize enforcement action against homeopathic drugs in the following categories:
- Products with reported safety concerns;
- Products that contain or claim to contain ingredients associated with potentially significant safety concerns;
- Products for routes of administration other than oral and topical;
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
- Products for vulnerable populations (e.g., infants, children, etc.); and
- Products that are adulterated under section 501 of the Federal Food, Drug, and Cosmetic Act, i.e., products that do not meet standards of quality, strength or purity as required under the law, or for which there are significant violations of current good manufacturing practice (cGMP) requirements.
There are also a few other key points relating to FDA’s regulation of homeopathic products that are worth noting. First, FDA’s draft guidance states clearly that “[t]here are no drug products labeled as homeopathic that are approved by FDA.” Draft Guidance at 2. Despite the proliferation of homeopathic drugs in the marketplace over the past two decades, FDA notes that it has not reviewed any homeopathic drugs under the OTC drug program because the Agency placed them in a separate category in the early 1970’s and deferred its consideration of them. Second, FDA makes clear that its new approach is driven by concerns about what is in the best interest of the public. FDA’s concurrent press release indicates that the Agency’s new approach is in direct response to highly publicized controversies such as the Hyland’s homeopathic teething tablet and gel incident in which Hyland’s, a homeopathic manufacturer, did not immediately recall its teething products in response to FDA concerns about adverse reports. Finally, in contrast to recent media reports over the weekend that the Centers for Disease Control is no longer permitted to use certain terms, including “evidence-based,” in documents being prepared for next year’s budget, the draft guidance emphasizes that “[t]he FDA’s evidence-based systems for the review of drugs under new drug applications (NDAs), biologics license applications (BLAs), and the OTC Drug Review play an essential role in ensuring that drugs are both safe and effective.” Id. at 2 (emphasis added).
Next Steps for Homeopathic Manufacturers
In a press conference held shortly after release of the draft guidance, FDA assured the public that it does not intend to remove all homeopathic drugs from the market or insist that all homeopathic products undergo the standard rigorous drug approval process. Instead, the revised policy is designed to target homeopathic drugs that pose safety risks. Thus, manufacturers should continue to follow the suggestions outlined in our earlier discussion of these issues:
- Ensure that products comply with applicable cGMP regulations;
- Include only active ingredients recognized in the Homeopathic Pharmacopeia of the United States and its addenda and supplements;
- Market OTC products only for conditions which qualified experts would agree are amenable to self-diagnosis; and
- Seek expert advice and review of advertising claims.
Additionally, in light of FDA’s new draft guidance, manufacturers should consider the increased risks associated with marketing homeopathic drugs for vulnerable populations such as children, the elderly, and pregnant women, or in forms other than topical or oral, and whether supporting data and/or labeling statements are adequate to mitigate those risks. Finally, if FDA expresses concerns about a given homeopathic drug or category of homeopathic drugs, manufacturers should take immediate action to address those concerns.
Comments on the draft guidance are due by 90 days after publication in the Federal Register (March 20, 2018).
 See Comments of the Staff of the Federal Trade Commission, Docket No. FDA-2015-N-0540-8620, available at https://www.ftc.gov/system/files/documents/advocacy_documents/ftc-staff-comment-food-drug-administration-regarding-current-use-human-drug-biological-products/150821fdahomeopathic.pdf and Staff Report on the Homeopathic Medicine & Advertising Workshop, Federal Trade Commission (November 2016), available at https://www.ftc.gov/system/files/documents/reports/federal-trade-commission-staff-report-homeopathic-medicine-advertising-workshop/p114505_otc_homeopathic_medicine_and_advertising_workshop_report.pdf.