A Georgia-based company that produces dietary supplements containing the ingredient 1,3 Dimethylamylamine (DMAA) has filed an action for declaratory and injunctive relief against the U.S. Food and Drug Administration (FDA) alleging that the agency "has engaged in a campaign of intimidation against dietary supplement companies" that include the ingredient in their products and has done so without notice or engaging in proper rulemaking procedures to formally ban DMAA. Hi-Tech Pharms., Inc. v. Hamburg, No. 13-1747 (U.S. Dist. Ct., D.D.C., filed November 5, 2013).
The complaint notes that FDA had issued an administrative detention order against the company’s goods, and, according to FDA, a week later U.S. marshals seized 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods containing DMAA with an estimated value of $2 million from the company’s Norcross facility.
While FDA contends that DMAA is "an unapproved food additive that is deemed unsafe under the law," the company alleges that the ingredient "has existed in the food supply for many years" and that it "has sold over a million bottles of dietary supplement products containing this ingredient without any adverse effects." Seeking to enjoin "FDA’s campaign of intimidation," the company calls for the agency to disclose "scientific evidence which brings the safety of DMAA into question . . . and engage in the formal rule making process to ban the ingredient." Hi-Tech Pharmaceuticals alleges that FDA has the burden of proving that a dietary supplement is adulterated and has failed to do so. Rather, "[i]n issuing warning letters, detention orders and seizure orders against DMAA, the Defendants have ignored the express intent of Congress and simply relied upon an unfounded presumption that a safe level could not be determined." Accordingly, the company contends that the agency has violated the Administrative Procedure Act, Dietary Supplement Health and Education Act and the company’s Fifth Amendment due process rights. See FDA News Release, November 18, 2013.