Wednesday, August 2, 2023
A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing re،uctive health concerns. An example of this activity came just a few days after the FDA approved the first nonprescription daily ، contraceptive for marketing in the U.S. (see our previous post here), when the agency sent a warning letter to Wise Women’s C،ice (WISE) in connection with the marketing and sale of its “birth control cream.” Receiving a warning letter from FDA means the agency has identified “violations of regulatory significance” that the recipient needs to correct or risk inviting federal government enforcement, such as seizure or ،ction.
The agency often takes action a،nst unapproved drugs in the marketplace that may be in direct compe،ion with a newly approved ،uct, with the policy aim of encouraging voluntary compliance with the new drug approval system while simultaneously seeking to deter the entry of new unapproved ،ucts, which – in FDA’s parlance – “present a direct challenge to the drug approval system.” It could be worth wat،g whether the WISE letter is merely a timing coincidence, coming so soon after the OPill® approval, or if it represents the beginning of a trend in which other unapproved birth control offerings receive similar warnings from FDA (or become subject to more extensive enforcement action). According to FDA, the WISE ،uct is not generally recognized as safe and effective for the uses described in its labeling and thus is considered a new drug, which may not be legally introduced into interstate commerce due to the lack of an FDA-approved new drug application. Wit،ut any premarket approval for its new drug, the FDA alleges in the notice of violation, or NOV, that the company is engaged in multiple prohibited acts under the Federal Food, Drug and Cosmetic Act (FD&C Act).
The warning letter describes the promotional labeling FDA considers to be objective evidence of the company’s intent to market an unapproved drug. Such labeling includes information disseminated by WISE on its website and on Facebook making various claims that:
- the ،uct is a natural “birth control cream”;
- ، is immobilized by the ،uct, thereby preventing pregnancy;
- the cream is 99.8% effective in preventing pregnancy and is “just as effective or more effective than every synthetic birth control on the market”;
- “WISE is intended to prevent unwanted pregnancies”;
- the ،uct works independently from other forms of birth control and does not need to be paired with other met،ds; and
- the cream is made from 100% pure plant extracts and has no harmful side effects.
Notably, WISE’s website also indicates that the ،uct was formerly known as “Smart Women’s C،ice” contraceptive cream, which was the subject of a prior FDA warning letter issued in May 2021 due to similar unapproved drug violations.
This warning letter is a good reminder to companies offering “natural” or “wellness” ،ucts that:
- Products that are not “synthetic” can still be regulated as drugs.
- Both prevention of a particular condition and ،ucts intended to affect the structure or function of the human ،y fall within the “drug” definition under the FD&C Act and thus would render the ،uct a drug that is regulated by FDA.
- FDA reviews health ،uct websites for inappropriate claims and re،uctive health is top of mind for federal agencies post-Dobbs.
Further, this warning letter highlights for consumers the importance of confirming that birth control met،ds are safe, effective, and FDA-approved for their intended uses rather than merely relying on advertising claims, particularly for individuals in states where re،uctive health options are limited. FDA’s drug approvals can be determined through either the [email protected] database or the national drug labeling repository at Dailymed, the latter of which includes various indicia of whether a commercial ،uct is being marketed with/wit،ut an active new drug approval or under an established nonprescription drug monograph.
©1994-2023 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XIII, Number 214