FDA is changing the playing field by withdrawing its earlier Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on Drug Products Labeled as Homeopathic.
The CPG stated the conditions—including regarding ingredients, labeling, prescription status, and current good manufacturing practice—under which homeopathic drugs could lawfully be marketed.
The new guidance uses a risk-based approach to determine where FDA will prioritize enforcement and regulatory actions.
FDA announced it stance in a press release, FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.
In its press release, FDA makes clear that it regards the market for homeopathic drugs as one that “exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims.” FDA also states:
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
In the Draft Guidance on Drug Products Labeled as Homeopathic, FDA prioritizes the following categories:
- products with reported safety concerns;
- products that contain or purport to contain ingredients associated with potentially significant safety concerns;
- products for routes of administration (for example: injectable) 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; and
- products deemed adulterated.
FDA’s draft guidance follows on the heels of FTC’s new enforcement policy, which was tough on homeopathic products, and stated that FTC would hold efficacy and safety claims for over-the-counter homeopathic drugs to the same standard as other products making similar health claims. . See our earlier post:
The Federal Trade Commission (FTC) has slammed homeopathic drugs with a guidance document on substantiation. This is perhaps the biggest regulatory backlash against homeopathic medicine since [...]
Unlike the former CPG, which articulated the basis on which homeopathic drugs could be legally marketed, the draft guidance focus on the fact that homeopathic products, according to the FDA spokesperson quoted, “’ have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality.’” The emphasis is on protecting the public and on articulated the particular categories that are likely to trigger enforcement.
Because of FDA’s jurisdiction over drugs in interstate commerce, distributors as well as manufacturers must add caution in the new regulatory environment of even more heightened scrutiny. Distributors of homeopathic products should also understand the new FDA guidance document, and not simply rely on manufacturers. While FDA classically does not have enforcement authority over the practice of medicine—as this is left to the states—FDA’s enforcement state could potentially affect state enforcement agencies looking at healthcare practices, too.
We also predict that FDA is likely to initiate a wave of enforcement actions against selected targets that falls within one of the above six, risk-based categories, as a warning that the new enforcement policy is real.
If you have questions regarding FDA law and policy with regard to homeopathic drug products, contact our FDA legal and regulatory lawyers now.