The Food and Drug Administration (FDA) recently proposed a new risk-based enforcement approach to homeopathic products. What is homeopathy, you ask? According to the National Center for Complementary and Integrative Health, homeopathy is based on “like cures like”—the idea that a disease can be cured by a substance that produces similar symptoms in healthy people. Homeopathic products use “natural” ingredients such as plants, minerals and animal derivatives.
Some homeopathic products such as Zicam or Cold-eeze to treat cold symptoms are sold in regular pharmacies next to the aspirin and antacids, while others are a bit more niche. But what was for a time a fairly small community has now grown into a $3 billion industry.
The homeopathic community has faced increasing scrutiny in recent years due at least in part to a lack of clinical evidence to back up many product’s claims. In addition, there have been reports of serious adverse events with a handful of homeopathic products including a brand of teething tablets for children that were tied to seizures and even death.
Similar to dietary supplements, the FDA does not review the safety or efficacy of homeopathic products before they are sold. The majority of homeopathic products do not have serious health concerns so the FDA’s approach allows the agency to target products that pose the greatest safety risks, particularly products marketed for children and for the treatment of serious diseases such as cancer or Alzheimer’s.
In our current environment of frozen and/or diminishing federal resources, this framework is an incredibly important tool for the FDA to address new and growing industries. The agency can conduct oversight and weed out bad actors without undertaking the review of every single product.
FDA’s recent proposal could also help the industry gain more credibility and alleviate consumer concerns. By cooperating and continuing to develop their relationship with the FDA, the homeopathic industry may even be able to convert some of it’s critics.
It is unclear at this point to what extent – if any – the homeopathic industry was aware of or involved in the development of this proposal, but it is a good lesson for nascent industries broadly about the value of engaging with regulatory bodies sooner rather than later. With innovation moving so quickly it is incumbent upon new businesses to educate government stakeholders on the work they are doing so that when (not if) there is a shift to a more pro-regulation environment they aren’t left out of the conversation.
What do you think about the FDA’s approach? What other things do businesses need to consider in this context? Let us know at firstname.lastname@example.org.