Attorney Robert Tauler can understand the challenges the FDA faces in holding distributors accountable for products marketed as dietary supplements but contaminated with undeclared prescription drugs.
His law firm, Tauler Smith LLP, has estimated that there are 10,000 variant names of similar male enhancement products that contain adulterants. They have names like Black Mamba Premium, Rhino 8 Platinum 8000, and Stiff Nights.
“We obviously haven’t tested the 10,000,” Tauler admitted in a phone interview, “but it’s pretty obvious from the scam what’s going on.”
Speaking from his office in Los Angeles, the trial attorney reviewed a sample of a Rhino product he obtained while highlighting an issue the FDA is facing: even after the public health agency targeted a potentially dangerous product, such as Rhino 8 Platinum 8000, a product from an FDA lab found to contain the active ingredient in the prescription drug Viagra – a similar one with a slightly different name variation is emerging in the US market.
FDA disclosed last week that since 2007, it has identified more than 25 marketed products with variations of the name “Rhino” that contained one or more hidden drug ingredients. The FDA has warned consumers to avoid male enhancement products named Rhino which contain hidden medicinal ingredients and are associated with an increasing number of reported health problems.
The products, the FDA explained, contain undeclared ingredients that are the same or structurally similar to the active ingredients found in prescription drugs approved by the FDA and used to treat erectile dysfunction, including sildenafil and / or tadalafil, the active ingredients of Viagra and Cialis. , respectively.
The FDA has reported that Rhino products continue to be sold at gas stations and convenience stores and on websites such as Amazon and eBay. The agency also identified the products in international mailings.
Retailers in legal sights
One of Tauler’s clients developed a strategy to combat the potential danger to consumers: sue convenience stores that sell male enhancement products that contain drugs and marketed as supplements.
Enter Outlaw Laboratory LP, a food supplement manufacturer in Texas whose male enhancement products allegedly contain only natural ingredients, such as yohimbe extract, Xanthoparmelia scarbosa extract and gamma amino butyric acid (GABA).
The company has filed lawsuits in Arizona, California, Georgia, Michigan, Nevada and Texas under Lanham Law, a federal law that creates a cause of action for unfair competition. In a lawsuit filed in Arizona, for example, Outlaw Laboratory accused defendants of “false and misleading statements and advertisements” that present “extreme risks to the health of consumers in at least two ways,” including failing to disclose Rhino products containing sildenafil.
“The proliferation of mislabeled male enhancement pills has grown in the shadow of intermittent enforcement of nutritional supplement laws,” the lawsuit proclaimed. “In this regard, the FDA has issued several public notices regarding the use of sildenafil in over-the-counter” male enhancement “supplements, but [FDA] took action in only a few cases. Supplier defendants and retail defendants have taken full advantage of this regulatory landscape, making significant profits by selling unsafe products while openly engaging in illicit activities. ”
Retailers, Tauler noted in the interview, buy male enhancement products for $ 1 to $ 2 each and sell them for $ 9 to $ 10 each.
“Under Lanham Law, retailers are responsible for what they sell because they disseminate false statements, and the law provides that they take… some liability,” said the lawyer.
Commenting on male enhancement products contaminated with undeclared drugs, he said, “Retailers will tell you ‘We had no idea this was the case’ and in some cases they can be serious about it. perspective. And some may not be sophisticated enough to critically examine the… evidence of fraud in these transactions that might worry a more sophisticated storefront.
Outlaw Laboratory has also sued distributors in California and Nevada, Tauler revealed, although he described many of them as “very devious” and difficult to locate.
“They don’t often have brick and mortar outlets,” he said. “They’re distributed through a network of what they call ‘resellers’ who go to convenience stores across the United States and deliver these products.
“Often the invoices, which we were able to obtain thanks to our efforts, do not bear the name of any entity,” the lawyer continued. “When they do, these entities are often not registered with the Secretary of State. “
Most transactions between retailers and wholesalers are cash transactions.
“In many cases… due to the nature of the business, it is very difficult to link a particular distributor to a particular retailer,” Tauler concluded.
Stand up to continue
Complaints against convenience stores are in the early stages of litigation. On November 28, Atlanta-based U.S. District Judge Amy Totenberg dismissed a motion to dismiss filed by a defendant, ABCDP Inc., in one of those lawsuits.
Company lawyers, who decided to dismiss an amended complaint on the basis of legal theory that Outlaw Laboratory lacked “standing” to bring the case, did not respond to a request for comment. .
The fact that Outlaw Laboratory “and ABCDP are not direct competitors (i.e., they are not both manufacturers of male enhancement products) does not, at this point, mean insufficient pleading, ”Totenberg wrote in his 21-page order.
However, she cautioned that Outlaw Laboratory would have to prove one piece of its record – “immediate causation,” that the retailer’s conduct caused immediate damage to the plaintiff’s commercial reputation or business interest – once the parties have completed the discovery in the lawsuit.
The court ruling “confirms that false advertising of illicit male enhancement pills in convenience stores falls within the scope of Lanham Law,” Tauler said in an emailed statement.
The ruling, he added, allows Outlaw Laboratory to continue its legal action “and will have a broad impact outside of the case as it will be a compelling authority for judges in other federal districts who have cases. similar to the study ”.
Filling the FDA Application Gap
In the interview, Tauler responded to criticism that the FDA was not doing enough to crack down on contaminated products, such as Rhino male enhancement products fraudulently marketed as dietary supplements.
“The FDA has a lot on its plate,” he said. “Sure, they could do more, but there are other crises going on, like the opioid crisis that deserve their attention.”
He argued that the FDA faces similar constraints targeting issues in the sports supplement industry. Tauler’s law firm has sued sports nutrition companies for selling selective androgen receptor modulators (SARMs), which the FDA says do not belong in dietary supplements and are potentially dangerous ingredients.
“The federal government,” Tauler said, “is simply not in a position to develop expertise for these niche markets.”
In its press release regarding Rhino products, the FDA advised consumers to be wary of products promoted for sexual enhancement, weight loss, bodybuilding, and / or pain relief.
“The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market,” the press release said. “However, it is not possible for the agency to test and identify all contaminated products.”