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OTC supplement worked like prescription drug because it was prescription drug

By Rebecca Tushnet

Jackson v. Balanced Health Products, Inc., 2009 WL 1625944 (N.D. Cal.)

Grady Jackson and Kelley Alexander brought a consumer class action against dietary supplement retailer defendants the Vitamin Shoppe and GNC, among others, who moved to dismiss. The case is about StarCaps, promoted by defendant BHP and its principal, Nikki Haskell. Haskell promoted StarCaps as an ?all natural? OTC diet pill with garlic and papaya extract as its main active ingredients. Each bottle comes with a pamphlet promising: ?This all natural dietary supplement detoxes your system by metabolizing protein and eliminating bloat. It's safe, fast and effective, and it contains no ephedra. Lose between 10 and 125 pounds and keep it off!?

In late 2007, The Journal of Analytical Toxicology ran an article, ?Detection of Bumetanide in an Over-the-Counter Supplement.? The Center for Human Toxicology used high performance liquid chromotography revealing that all the StarCaps it tested contained near-therapeutic doses of Bumetanide, a prescription drug that is banned by the NFL. Bumetanide is prescribed to treat edema, but it can also mask steriod use.

Plaintiff Grady Jackson is an NFL player who began taking StarCaps in 2008 to help him lose weight. He tested positive for Bumetanide and was suspended. He?s appealing the suspension. When Jackson?s positive drug test became public, BHP issued a statement that it had temporarily suspended shipments of StarCaps to retailers. But retailers kept selling StarCaps until BHP issued a voluntary recall.

The other named plaintiff is a California resident who bought StarCaps for over four years because it was represented as an all-natural dietary supplement.

The retail defendants claim to have quality control standards to monitor supplements from the vendors it uses.

The plaintiffs sued for unfair competition, false advertising, and other torts.

The court began by discussing preemption. There?s no express preemption of false advertising claims about dietary supplements, but there?s also no private right of action for violations of the FDCA. Defendants argued that plaintiffs were trying to sue for violations of the FDCA, and that the premise of the complaint is that the supplement was was (1) improperly labeled and (2) sold OTC but contained a prescription-only drug, both of which constitute misbranding under the FDCA.

Here, the claims were based on false advertising and mislabeling under the Sherman Law; they didn?t depend on FDCA violations. There was no preemption, though some of the non-false advertising claims were dismissed on other grounds.

Full post as published by 43(B)log on June 21, 2009 (boomark / email).