On October 24, 2019, the U.S. Food and Drug Administration (FDA) announced a revised enforcement program for homeopathic drug products due to what FDA described as “the recent growth of safety concerns,” including serious adverse events associated with homeopathic drug products and serious violations of cGMP requirements.
1
The announcement was accompanied by: (1) a
Federal Register notice
withdrawing Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed” and (2) the issuance of a revised Draft Guidance, “
Drug Products Labeled as Homeopathic – Guidance for FDA Staff and Industry
” (October 2019; originally published in December 2017) (“Draft Guidance”).
We summarized the original draft guidance in a
December 2017
post and provided additional insight into the enforcement policies of FDA and the Federal Trade Commission (FTC) in a
March 2017
blog post. This Alert summarizes FDA’s most recent actions.
Withdrawal of CPG 400.400
FDA issued CPG 400.400 in 1988 to describe its enforcement policy regarding homeopathic drugs. “
Conditions Under Which Homeopathic Drugs May be Marketed
.” The CPG described the conditions under which homeopathic drug products without premarket approval may be marketed, including conditions regarding ingredients, labeling, prescription status, and current good manufacturing practice. However, based on the passage of time, the growth of the industry, and highly publicized incidents involving homeopathic drug products, FDA decided to revisit this approach.
In 2017, with the issuance of a draft guidance, FDA stated its intention to withdraw CPG 400.400 when it issued a final guidance on drug products labeled as homeopathic. However, with the October 2019 Federal Register notice, FDA announced the withdrawal of the CPG in advance of a final guidance. In justifying its decision to immediately withdraw CPG 400.400, FDA stated that it encountered “multiple situations in which homeopathic drug products posed a significant risk to patients” even though the products, as labeled, appeared to meet the conditions of CPG 400.400.
2
FDA noted that CPG 400.400 does not address important considerations “such as the product’s intended use, dosage form, frequency of use, manufacturing quality, intended patient population, and the quantity and combination of ingredients.”
3
Accordingly, FDA concluded, “[b]ecause CPG 400.400 is inconsistent with the Agency’s risk-based approach to enforcement generally, it does not accurately reflect the Agency’s current thinking.”
4
In announcing this withdrawal and the Agency’s intention to apply a risk-based approach to prioritizing regulatory and enforcement action, FDA reiterated that homeopathic drug products remain subject to the same regulatory requirements as other drugs, including those related to approval, adulteration, and misbranding.
Issuance of a Revised Draft Guidance on Drug Products Labeled as Homeopathic
FDA’s revised Draft Guidance largely tracks the substance of the December 2017 version. Notable revisions include the addition of a definition for “homeopathic drug product” for purposes of the Draft Guidance, additional explanation of some of the safety issues that led to the development of the Draft Guidance, and clarification of FDA’s intent to use risk-based factors to prioritize its enforcement approach to the manufacturing, distribution, and marketing of homeopathic drug products.
The Draft Guidance states that the Agency anticipates that many homeopathic drug products will fall outside the categories of drug products that FDA intends to prioritize for enforcement action and elaborates on the previously described six categories of products that potentially pose higher risks to public health:
- Products with reports of injury that, after evaluation, raise potential safety concerns;
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns;5
- 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 or conditions;
- Products for vulnerable populations (e.g., infants, children, and the elderly); and
- Products with significant quality issues.
Pending issuance of the final guidance, FDA states that it intends to use the risk-based enforcement approach described in the Draft Guidance.
Recent Enforcement Activity and Next Steps
FDA’s enforcement surrounding homeopathic drug products remains active. To date, in 2019 alone FDA has issued more than 10 warning letters to companies for violations concerning the manufacturing and/or labeling of homeopathic drug products.
6
In light of the withdrawal of CPG 400.400 and the issuance of the revised Draft Guidance enumerating FDA’s enforcement priorities, companies selling homeopathic drug products would be well advised to implement the following practices:
- 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 drug products only for conditions which qualified experts would agree are amenable to self-diagnosis;
- Seek expert advice and review of advertising claims to make sure they meet FTC substantiation standards; and
- Consider the increased risks associated with marketing homeopathic drug products to vulnerable populations or in forms other than topical or oral, and whether supporting data and/or labeling statements are adequate to mitigate such risk.
FDA is accepting comments to the revised Draft Guidance through January 23, 2020.
- Press Release, U.S. Food & Drug Admin., “Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products” (Oct. 24, 2019) (“Press Release”).
- Id.
- 84 Fed. Reg. 57439, 57440 (Oct. 25, 2019).
- Concurrent with the withdrawal of the CPG and issuance of the revised Draft Guidance, FDA denied the Citizen Petition submitted by Americans for Homeopathy Choice in 2018 which requested, among other things, that FDA either retain CPG 400.400 or convert it to a regulation and withdraw the original draft guidance. See U.S. Food & Drug Admin., Response Letter to Americans for Homeopathy Choice Citizen Petition (Oct. 24, 2019).
- Examples include: (1) infectious agents with potential to become pathogenic, (2) controlled substances, (3) multiple ingredients that together may raise safety concerns, and (4) ingredients that pose potential toxic effects, particularly when such ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C) or are not adequately controlled in the manufacturing process.
- Press Release.
