Is it a food or is it a drug?  The answer makes a difference because different laws apply.  And then there are dietary supplements, which come under the “food” umbrella, but have some unique rules of their own.  It can get complicated, but one thing is for sure—the proper outcome of litigation can depend on getting your dispute into the correct bucket.  That is one lesson from Kanfer v. Pharmacare US, Inc., No. 15-cv-0120, 2015 U.S. Dist. LEXIS 150105 (S.D. Cal. Nov. 4, 2015), where the district court somehow treated the product at issue as a food, and a drug, and a dietary supplement all at the same time, resulting in the court allowing the plaintiff to proceed on all counts.  The truth is that the matter should not have proceeded at all beyond the pleadings.

Here is what happened. The product at issue in Kanfer is an over-the-counter male sexual performance enhancer, a combination of herbs and spices about which the seller makes various claims.  Many of them would get trapped in your spam filters, but the gist is that the product is “designed to intensify your endurance, stamina, and sexual performance” so you can make a “long lasting impression.”  Id. at **3-4.  The list of ingredients includes a number of herbs plus “ginger, cinnamon, nutmeg, and cayenne.”  Id. at *3.  Yikes.  This sounds more like the ingredients for a warm beverage that one would sip after a chilly evening of Christmas caroling, not a performance supplement, but what do we know?

We do know that the search for products that can improve your sex life has been underway for millennia, and we also expect the industry dedicated to selling such products is substantial.  It is no doubt substantial enough to attract litigation, as in Kanfer.  The plaintiff was a fellow who purchased the product and claimed that “it did not deliver the promised benefits.”  Id. at *4.  He therefore sued on behalf of himself and a nationwide class of others who bought the product, alleging multiple warranty and consumer protection claims under California law.  Id. at *2.

Jumping ahead for a moment, we have difficulty imagining how the plaintiff intends to prove that the product “did not deliver the promised benefits” by common proof for a nationwide class of purchasers.  But we don’t need to get there in this post because the claims should have been preempted by the FDCA.  The plaintiff had three theories of liability:  First, he claimed the product was a misbranded dietary supplement because it made a “disease claim,” i.e., that the product could treat medical conditions such as erectile dysfunction and diminished libido.  Id. at *6.  Second, he claimed that the product was misbranded because it was promoted as an aphrodisiac, which the FDA has said requires approval as a new drug.  Id. at **6-7.  Third, he claimed the product’s labeling was false and misleading under California’s false advertising laws because it could not deliver the promised “aphrodisiac and sexual health benefits.”  Id. at *7.

These allegations set a pretty clear path:  This lawsuit is claiming the sale of an unapproved drug.  FDA regulations state that any product that “bears labeling claims that it will arouse or increase sexual desire, or that it will improve sexual performance, is an aphrodisiac drug” that must be approved as a new drug.  21 C.F.R. § 528.  The dietary supplement regulations jibe with this—they state that if a product makes a “disease claim,” it is subject to regulation as a drug.  21 C.F.R. § 101.93(f).  A “disease claim” is a representation that a product can “diagnose, mitigate, treat, cure, or prevent a specific disease,” which would include erectile dysfunction and libido disorders.  See 21 U.S.C. §343(r)(6).  From there it is a short step to implied preemption under Buckman and 21 U.S.C. § 337(a), which gives the FDA exclusive authority to enforce the FDCA.

Unfortunately, the district court saw it differently and allowed the plaintiff’s lawsuit to proceed.  Rather than apply the law applicable to the alleged drug product, the district court parsed each of the manufacturer’s representations and applied various laws to various representations—applying food laws to some and drug laws to others in a sort of patchwork fashion.

Here is where the analysis left the rails.  The FDCA has an express preemption provision for food labeling, which preempts any state food-labeling requirements that are “not identical to” federal requirements.  Based on this, the court reasoned that some of the plaintiff’s theories were expressly preempted because they were based on representations that were “inconsistent with what the FDA requires.”  Id. at **12-13.  But theories based on other representations (the “disease claims”) were not preempted because California’s food labeling law “incorporates and hence parallels federal law,” resulting in no preemption.  Id. at **13-14.  The same went for the plaintiff’s theory on drug misbranding, because it “paralleled” FDA’s drug regulations, and also his misleading labeling theory, because state false advertising laws are “consistent with” the FDCA’s prohibition on misleading food labeling.  Id. at **14-15.

Maybe we are underthinking this, but why is the court even talking about express preemption and “parallel” claims?  The court acknowledged that if a product makes a “disease claim,” it is regulated as a drug, yet the court cited and relied on the express preemption provision for food labeling.  Even when discussing this product’s disease claims directly, the court labored to find a “parallel” claim to avoid express preemption, when the straighter course would have been to acknowledge that the food preemption provision does not apply in the first place.

The focus should have been on implied preemption, and on that issue, the court came to the wrong result on the wrong reasoning.  As we noted above, the plaintiff’s claims are impliedly preempted because they are a private right of action to enforce the FDCA, specifically its prohibition on selling unapproved drugs.  The court got around this by citing a California Supreme Court case purportedly holding that section 337(a) does not preempt consumer food labeling claims because the “express-preemption provisions that apply to food labeling expressly allow parallel state laws.”  Id. at *17.  Without commenting on whether the California Supreme Court was right or wrong (we did that already here), its opinion does not support the district court’s result.  This is a drug case, not a food case.  And the issue here is implied preemption, not express preemption.

We have seen this before—a court importing the much-misunderstood “parallel claim” doctrine into implied preemption analysis, and we don’t like it.  Under implied preemption, the question is whether compliance with state law poses an obstacle to accomplishment and execution of the full purposes and objectives of Congress or whether it is impossible to comply with both state and federal law.  Whether state law “parallels” federal law is beside the point.  Congress gave the FDA exclusive authority to determine whether a product should be regulated as a drug, and that authority cannot co-exist with 50 states and their courts undertaking the same task.  As we have observed, imagine if state officials or courts of law came to different results for the same product, a scenario that we view as likely.  That would be an obstacle to the federal purpose of uniform federal regulation of the marketing of drugs.

The court went on to rule that the plaintiff had sufficiently stated his claims, observing that “many of the issues raised are better suited for summary judgment or class certification.”  Id. at *33.  So clearly this district court wanted this case to proceed beyond the pleadings, and maybe the court viewed the product and its promises with a jaundiced eye.  We don’t know, but regardless, we view its analysis of this product and federal preemption with a healthy dose of skepticism.