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Thursday, March 28, 2024 | Back issues
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Vitamin Shopped Cleared on Spiked Supplement

CHICAGO (CN) - The Vitamin Shoppe is not liable for selling diet supplements containing DMAA since there is no proof the maker knew that the performance-enhancing substance was dangerous, a federal judge ruled.

DMAA (dimethylamyllamine) is a synthetic compound and popular bodybuilding supplement, but the World Anti-Doping Agency bans it as a performance-enhancing substance.

In March 2012, the Vitamin Shoppe sold Rochelle Ibarolla a weight-loss supplement called Lipo-6 Hers Ultra Concentrate, which did not indicate DMAA as an ingredient.

One month later, the FDA warned the supplement's maker, Nutrex Research, that "there is no history of use or other evidence of safety establishing that [DMAA] will reasonably be expected to be safe as a dietary ingredient." It declared six Nutrex products containing DMAA to be adulterated, including Lipo-6 Hers Ultra Concentrate.

Ibarolla filed a federal class action, seeking damages for fraud, unjust enrichment and violation of consumer protection statutes. She has since amended the claims.

U.S. District Judge Marvin Aspen found, however, that "plaintiff has not pled facts from which we can infer defendants' knowledge of the product's alleged dangers at the time plaintiff made the purchase."

"In our order dismissing the original complaint, we explained that we could only infer defendants knew about the dangers of DMAA after Nutrex received the Warning Letter from the FDA," he wrote. "The same conclusion applies here. ... An absence of knowledge regarding a product's safety does not imply actual knowledge of a product's dangers."

While Ibarolla claims that Nutrex had a duty to investigate the safety of its products, this "does not mean defendants actually fulfilled their duty," according to the ruling.

"In fact, the FDA's reasons for sending the Warning Letter to Nutrex suggest precisely the opposite: 'Because the required notification has not been submitted, your products are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a),'" Aspen wrote. "In light of Nutrex's failure to meet these FDA requirements, which prompted the Warning Letter in the first place, the requirements themselves provide no basis for inferring that Nutrex investigated the dangers of DMAA prior to receiving the letter."

Ibarolla also accused Nutrex of concealing other ingredients in its products that are harmful if consumed in large quantities or in combination, but she did not specify the level at which these ingredients are dangerous.

"There are many substances that are severely harmful at certain levels of exposure, but acceptably safe in smaller quantities," Aspen wrote. "Almonds, spinach, and lima beans all contain the potentially fatal chemical cyanide, for instance, but grocery stores that fail to warn their customers of that fact are not liable for fraud, because under normal conditions those foods are perfectly safe."

"Plaintiff argues that she cannot possibly know the quantities of the ingredients in the product, because Nutrex 'refers to the formulation as a 'proprietary blend,'" he added. "We are mindful of the fact that 'in fraud cases, there is an exception to the particularity requirement when the facts on which the allegations are based are in the defendant's control.' Accordingly, we do not require plaintiff to allege the actual composition of the product. But even under this more relaxed standard, plaintiff must still provide some factual basis for her allegation."

In dismissing the claims against Vitamin Shoppe, Aspen said, "clearly, Nutrex could not have informed Vitamin Shoppe of any dangers that it was unaware of itself."

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