- SPECIAL FOCUS: The FDA and Zicam
- July 15, 2009
- Law Firm: Manatt, Phelps & Phillips, LLP - Los Angeles Office
Recently, Zicam hit the news in a big way when the FDA warned consumers not to take certain products. This week our newsletter editors interview Manatt partner and FDA specialist Ivan Wasserman on what happened and what it means from a marketing standpoint.
Editors: What is the problem with Zicam?
Wasserman: There have been many reports that people who used the Intra-Nasal forms of Zicam lost their sense of smell. For some, the loss is apparently permanent.
Editors: What did the FDA do?
Wasserman: The FDA did two things. First, it issued a public notice warning consumers not to use these Zicam products. Second, it sent a Warning Letter to Matrixx Initiatives, Inc., the company that markets the products, informing the company that the products, which are homeopathic, are unapproved new drugs and therefore cannot be marketed. The FDA also expressed concern that Matrixx had apparently not told the FDA about hundreds of reports of loss of smell that it had received.
Editors: What is a “homeopathic” product?
Wasserman: Homeopathy is a type of medical practice that has been around for hundreds of years. It is based on the theory of “like treats like.” If a patient has a particular condition, the patient is given a homeopathic drug which contains a minute amount of a substance that is thought to cause that same condition when taken in larger amounts.
Editors: How are homeopathic products regulated by the FDA?
Wasserman: They are regulated as drugs. However, under a long-standing enforcement policy, the FDA generally does not require them to be approved prior to marketing. In the Warning Letter to Matrixx, the FDA took the position that if a homeopathic product presents a safety risk, the enforcement policy does not apply, and the product must go through the FDA drug approval process.
Editors: What is the takeaway from this for marketers?
Wasserman: There are several important lessons here. First, with this action and the recent Hydroxycut recall, it seems that the FDA is increasingly willing to take action when it perceives a potential safety issue with a product. It is therefore more important then ever to ensure the safety of your products. Second, and related to that, it is important to have procedures in place to monitor consumer complaints and know when such complaints must be submitted to the FDA. Third, while the Zicam case is not about advertising claims, it is important to know that just because a homeopathic product does not need to be approved by the FDA, claims for the product are subject to FTC enforcement and therefore must be supported by competent and reliable scientific evidence.