By Celeste D. Wheeler
FDA’s recent aggressive enforcement action against homeopathic teething tablets and gels brings into sharp focus the dilemma facing manufacturers of homeopathic drugs, i.e. how can a claim be made based on traditional principles of homeopathy in an environment where the only legally acceptable substantiation is based on allopathic standards? This update briefly (1) describes the simmering tension between the U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) following the FTC’s November 2016 announcement that it would hold advertisements for homeopathic drugs to the same scientific substantiation standards it applies to claims for other healthcare products and (2) offers suggestions for navigating homeopathy’s uncertain future in light of a recent FDA announcement that it plans to release guidance on homeopathic drug products later this year.
I. The Homeopathic Teething Product Controversy
In September 2016, homeopathic medicine received considerable unfavorable media attention when FDA issued a press release warning against the use of homeopathic teething tablets and gels, including products distributed by CVS and Hyland’s. The release warned that “[h]omeopathic teething tablets and gels have not been evaluated or approved by FDA for safety or efficacy” and that the agency was “not aware of any proven health benefit of the products.” This was not the first time that homeopathic teething products had become the focus of agency attention. In 2010, following an FDA inspection identifying some manufacturing issues, Hyland’s voluntarily recalled its homeopathic teething products and reformulated its product to include less of the active ingredient, belladonna.
This time, however, FDA took the unusual step of issuing a public warning against all use of this class of homeopathic products after receiving reports alleging serious adverse events in infants and children administered the medicine. In response, Hyland’s chose to discontinue sales of its homeopathic teething medicines in the United States because it did not want to put consumers “in a position of having to choose who to trust in the face of contradictory information.” However, the company did not immediately recall its products, stating instead that it remained confident in their safety and noting that the company had not been presented with any data or information contradicting its data. In October 2016, the company reiterated its request for the data supporting the FDA warning.
In January 2017, FDA announced that its laboratory analysis of the Hyland’s products found inconsistent levels of belladonna, which FDA described as a “toxic substance” which presented an unnecessary risk, On April 7, 2017, FDA requested an immediate recall of any remaining Hyland’s teething products in the marketplace, perhaps signaling that FDA intended to initiate a seizure action if Hyland’s failed to comply. Hyland’s finally capitulated, and on April 13, 2017, issued a product recall. Although this particular controversy has been resolved for now, FDA’s relentless enforcement actions, including the issuance of request for a recall, suggest that FDA is increasingly concerned about the safety of homeopathic products and will aggressively pursue those homeopathic products it views as threatening public safety.
II. FDA Regulatory Approach to Homeopathic Drugs
In its September 2016 teething product warning, FDA advised consumers that it had not evaluated or approved the homeopathic teething products for safety or efficacy, however, this is true of all homeopathic drugs. Homeopathy can be traced to the late 1700s and Dr. Samuel Hahnemann. The basic principle of homeopathy is that symptoms of disease can be cured by administering very dilute doses of substances that cause similar symptoms in healthy people. Senator Royal Copeland of New York, a homeopathic physician, is largely credited with the inclusion of homeopathic products in the definition for drugs during the drafting of the Federal, Food, Drug, and Cosmetic Act (FFDCA). As a result of Copeland’s efforts, the term “drug” includes “articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them.” Homeopathic products must satisfy standards for strength, quality, and purity established by the Homeopathic Pharmacopeia.
Homeopathic drugs must comply with basic labeling requirements for drugs such as directions for use, statement of ingredients, and, for OTC products, indications for use. Current good manufacturing practice regulations, with limited exceptions for expiration dating requirements in 21 CFR 211.137 and testing and release for distribution requirements in 21 CFR 211.165, also apply to homeopathic drugs. However, FDA Compliance Policy Guide 400.400, Conditions Under Which Homeopathic Drugs May be Marketed (the “CPG”), makes clear that as long as an ingredient is officially recognized in the Homeopathic Pharmacopeia of the United States (“HPUS”), an addendum to it, or its supplement, it can be included in a homeopathic product without providing FDA with documentation or other scientific support regarding its use. Homeopathic products “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) may be marketed OTC.” Accordingly, unlike other drugs, homeopathic products are neither approved under a new drug application nor formally subject to an OTC drug monograph.
III. Recent FDA and FTC Discussions of Homeopathy
In April 2015, FDA held a public hearing to obtain stakeholder input on “current enforcement policies related to drug products labeled as homeopathic in an effort to better promote and protect the public health.” FTC submitted comments which were highly critical of FDA’s current regulatory approach. FTC’s comments began by explaining that FDA and FTC have worked collaboratively to regulate OTC products over the past 40 years pursuant to a 1971 Memorandum of Understanding under which FDA focuses on product labeling and FTC focuses on advertising. FTC noted that “[w]ith the exception of OTC homeopathic drugs [as] discussed [in FTC’s comments], the regulatory approach of the two agencies has been remarkably consistent.”
In September 2015, FTC held its own Homeopathic Medicine & Advertising Workshop to discuss the regulation of this class of products. The workshop was followed by the issuance of a stern November 2016 report in which FTC warned that marketers of homeopathic products “must either have adequate substantiation for their efficacy claims or effectively communicate the lack of scientific evidence backing them and that their claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” Thus, the FTC has been fairly open in its criticism of FDA’s current approach, and most industry commenters described the FTC report as the opening warning shot in FTC’s battle against homeopathic drugs. To date, however, FTC has not made public any specific new actions against homeopathic manufacturers. Of additional concern to industry, in early 2017, without offering an explanation, FDA quietly added “Drug Products Labeled as Homeopathic” to its guidance document regulatory agenda for 2017.
IV. Possible Implications of Recent Scrutiny of Homeopathic Market
FDA’s decision to add homeopathic drugs to its regulatory agenda without an explanation regarding the scope of the expected guidance left industry wondering whether FDA plans to respond to FTC’s announced enforcement policy by undertaking a wholesale revision of its approach to the regulation of homeopathic products. Indeed, the Federal Register notice announcing the April 2015 FDA hearing on homeopathic medicine noted that FDA had merely deferred review of homeopathic medicines in 1972 when it initiated proceedings to determine which OTC drugs were safe and effective. The notice further commented that at the time that the CPG was first issued, homeopathy was only a multimillion dollar industry, whereas sales had soared to an estimated $2.9 billion by 2007. Accordingly, it is possible that FDA plans to announce a revised compliance policy pending an attempt to initiate a more formal review.
On the other hand, despite the urgency conveyed in the FTC November 2016 staff report, both FTC and FDA already have tools at their disposal to regulate homeopathic products when public safety is an issue, and they have not hesitated to use those tools in the past. For example, in 2009, FDA and FTC collaborated to issue warning letters to manufacturers of products designed to treat swine flu. The letters warned that while the products at issue were homeopathic, the CPG merely “delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” FDA noted that the CPG contains the qualifying word “ordinarily” and that there are circumstances in which a product that otherwise qualifies for leniency under the CPG may become subject to enforcement action. Additionally, in 2011 when FDA and FTC encountered “unapproved ‘homeopathic’ HCG drug products” marketed for rapid weight loss when they did not contain an ingredient recognized in the HPUS, its addendum, or its supplements, FDA and FTC issued joint warnings that the products did not comply with the CPG or with the Federal Trade Commission Act which requires that claims be supported by competent and reliable scientific evidence. Finally, on occasion FDA has issued warning letters to companies when homeopathic products are being marketed OTC for conditions it believes are not amenable to self-diagnosis as well as for violations of good manufacturing practices.
All of this leaves the homeopathic industry facing a number of unresolved questions. The addition of homeopathic products to FDA’s guidance agenda could mean that FDA merely intends to grant renewed focus to ensuring that homeopathic products comply with the regulations which already apply to them. Another complicating factor is whether the new Trump administration’s focus on deregulation, as announced in the January 30, 2017 Executive Order 13771, will derail any additional regulatory scrutiny of homeopathic drugs. Interestingly, although the Department of Commerce recently issued a request for information about the impact of federal regulations on domestic manufacturing and asked for input on reducing regulatory compliance burdens, no one from the homeopathic industry offered comments.
IV. What Should Homeopathic Manufacturers Do Now?
So how should manufacturers proceed in light of this uncertainty? The Hyland’s example as well as recent warning letters indicate that manufacturers should, at a minimum:
- Ensure that products comply with all applicable cGMP regulations. Notably, in the Hyland’s example above, the most recent FDA announcement focused on the fact that the agency found inconsistent levels of belladonna in its laboratory analysis of the teething products.
- Include in homeopathic products only those active ingredients officially recognized in the HPUS and its addenda and supplements. Manufacturers who include ingredients not officially recognized in the HPUS are more likely to become targets of enforcement action.
- Market OTC products only for those conditions which qualified experts would agree are truly amenable to self-diagnosis.
- Seek expert advice and review of all advertising claims to ensure that they meet FTC standards
We will continue to monitor this issue and will post an update once FDA releases the homeopathic guidance later this year.
 See October 23, 2010 Press Release, https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/ucm230769.htm; Frequently Asked Questions, https://www.hylands.com/faq-about-discontinuation-teething-tablets-and-gel.
 Frequently Asked Questions, https://www.hylands.com/faq-about-discontinuation-teething-tablets-and-gel.
 October 12, 2016 Press Release, available at https://www.hylands.com/media/press-release/hylands-affirms-safety-its-Bowie, MD products-still-awaiting-data-behind-fda-warning.
 FDA Compliance Policy Guide Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed, at 1, available at https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm.
 Junod, Suzanne. An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation. Food Drug Law Journal 2000; 55:161-83.
 See 21 U.S.C. 351.
 CPG at 4.
 80 Fed. Reg. 16327 (March 27, 2015); see also Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter Century, available at https://www.fda.gov/Drugs/NewsEvents/ucm430539.htm.
Comments of the Staff of the Federal Trade Commission, Docket No., FDA-2015-N-0540-8620, at 3, 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.
 Staff Report on the Homeopathic Medicine & Advertising Workshop, Federal Trade Commission (November 2016) at 23-24, 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.
New & Revised Draft Guidances CDER Is Planning to Publish in Calendar Year 2017, available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm417290.pdf.
 80 Fed. Reg. 16327, 16328 (Mar. 27, 2015) (citing 37 Fed Reg. 9464, 9466 (May 11, 1972), in which FDA stated that “[b]ecause of the uniqueness of homeopathic medicine, the Commissioner has declined to exclude homeopathic drugs from this OTC drug review and to review them as a separate category at a later time after the OTC drug review is complete.”)
See 2010 Warning Letters: May 21, 2010 Warning Letter to Feel Good Natural Health, April 12, 2010 Warning Letter to E-Holistic, June 8, 2010 Warning Letter to Homeopathy for Health, April 13, 2010 Warning Letter to Shreeji Homeo Clinic, and May 21, 2010 Warning Letter to Zone of Natural Remedies.
 See e.g. November 28, 2011 Warning Letter to Creative Bioscience. FTC eventually filed a complaint against one such manufacturer, HCG Platinum, and obtained a permanent injunction.
 See e.g., December 1, 2016 Warning Letter to Aurora Health & Nutrition.
 See July 26, 2012 Warning Letter to A Nelson & Co.
 See Impact of Federal Regulations on Domestic Manufacturing, No. 170302221-7221-01 (Mar. 7, 2017), available at https://www.regulations.gov/docketBrowser?rpp=25&po=0&dct=PS&D=DOC-2017-0001&refD=DOC-2017-0001-0001.