On April 20, 2015 the Food and Drug Administration (FDA) heard testimony regarding homeopathic drugs and the Agency’s role in the regulation thereof. These two-day long hearings come after the FDA received over 1,500 public comments about the possibility of regulating homeopathic drugs in a manner consistent with over-the-counter (OTC) drugs. A primer for the public hearing can be found in the federal register, here.
Homeopathy began in the 18th century, based off of teachings from a German scientist, Samuel Hahnemann. The main concept in homeopathy is that, “like cures like” (similia similibus curentur) meaning that disease causing substances can also be used to cure those same diseases, if the substances are greatly diluted.
The FDA is considering whether homeopathic drugs should be treated like OTC drugs and undergo clinical trials to be proven safe and effective, as well as obtain approval for labeling. The new calls for regulation are in response to the current boom of the homeopathic industry in recent years. The last time that homeopathic drugs were examined by the FDA was in 1988. In 1988, homeopathic products were only a multimillion-dollar industry in the United States. According to the Center for Disease Control and Prevention, sales of homeopathic products reached nearly $3 billion in 2007. Due to the increased sales volume of homeopathic products and concern in recent years, the FDA believes that it now has more information to work with in order to make a decision.
Currently, homeopathic drugs are subject to various FDA administered laws and regulations. In particular, homeopathic drug manufacturers must also comply with certain FDA regulatory requirements, explained here in the compliance policy guide and explaining the conditions under which homeopathic drugs may be marketed. Further, manufacturers must also comply with the Food, Drug, and Cosmetic Act. Accordingly, industry advocates argue that the current regulatory scheme is more than adequate to ensure that consumers who choose homeopathic products receive safe and effective products.
Currently, the FDA is gathering information about homeopathic drugs in order to determine if they should be regulated like other over the counter medicines, like aspirin or decongestants and require approval for marketing. Because the state of laws and regulations applicable to homeopathic drugs may be changing very soon, any person or company in this industry should be on alert for changing requirements for their products. It is important to consult with an expert before any new policy comes into effect to ensure full compliance with new laws and regulations.
We offer comprehensive FDA compliance assistance, including label reviews and reviews of health claims to help our clients ensure that their products are in full compliance with FDA regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com.