On January 24, 2018, FDA and the Federal Trade Commission (FTC) posted joint warning letters to 11 marketers and distributors of opioid cessation products, alleging that those products were unapproved new drugs that violated the Federal Food, Drug, and Cosmetic Act (FDC Act) and made unsubstantiated, deceptive claims in violation of the FTC Act. Nine of the letters went to dietary supplement marketers, and two to marketers of homeopathic products. The FTC issued four additional warning letters to unidentified marketers of similar products, although it is not clear why those particular marketers (who apparently were not simultaneously targeted by FDA) were permitted to remain anonymous. While it is certainly not unprecedented for the FTC and FDA to issue joint warning letters, the large number of letters bespeaks the importance of this issue to both agencies.
At the end of 2017, an industry coalition of industry trade associations already reminded the industry and consumers that dietary supplement marketers cannot claim that their products treat opioid addiction or withdrawal symptoms. Under the FDC Act, such claims cause the products to be unapproved drugs. Moreover, FDA has taken the position that opioid addiction is a condition that is not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner and, thus, opioid cessation products cannot be sold over-the-counter. They are regulated as prescription drugs.
As noted above, two of the warning letters, the letter to King Bio, Inc. and the letter to GUNA, Inc., target products labeled as “homeopathic” drugs. Many drug products labeled as homeopathic are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide (CPG), which FDA acknowledges in the letters. However, as FDA explains, this does not mean that any product meeting the CPG conditions can be marketed without approval, because “the enforcement policies set forth in the CPG are not unlimited.” Rather, the CPG “delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” See FDA, Warning Letters to King Bio, Inc. and GUNA, Inc. (Jan. 11, 2018). There are special circumstances that supersede that policy, and the nationwide opioid crisis is one of those special circumstances.
As to the FTC Act violations, the letters note that the claims must be supported by competent and reliable scientific evidence at the time the claims are made. The FTC points to previous FTC enforcement actions challenging claims for the treatment of opiate addiction and withdrawal symptoms FTC v. Sunrise Nutraceuticals, LLC, and FTC v. Catlin Enterprises, Inc., as examples of the possible consequences of making unsupported claims.
FDA and the FTC have requested responses from all the companies within 15 working days.