A federal judge in Santa Ana, California, recently dismissed a lawsuit against a manufacturer of dietary supplements whose ingredients were flagged by FDA in warning letters.
The March 3 suit was filed in the U.S. District Court for the Central District of California on behalf of three individuals who purchased products containing three ingredients allegedly not safe for human consumption: 1-3-dimethylamylamine (DMAA), DMHA (1,5-Dimethylhexylamine) and methylsynephrine. In the complaint against Hi-Tech Pharmaceuticals Inc., the plaintiffs alleged negligent and intentional misrepresentations, as well as violations of California’s Consumer Legal Remedies Act, False Advertising Law and Unfair Competition Law.
U.S. District Judge David Carter dismissed the complaint after agreeing with Norcross, Georgia-based Hi-Tech that warning letters do not constitute final agency action. The judge warned if he moved forward with an analysis of whether the ingredients constitute dietary supplements, another court considering the legal status of DMHA, for example, could reach a different conclusion than him.
Carter found FDA was in the best position to determine whether the ingredients constituted dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
“Accordingly, the Court finds that the determination of DMAA, DMHA and methylsynephrine as dietary supplements under DSHEA requires both the expertise of the FDA and uniformity in administration,” Carter concluded in his July 29 order, which granted Hi-Tech’s motion to dismiss the complaint based on the doctrine known as primary jurisdiction.
Jack Wenik, an attorney in Newark, New Jersey, defending Hi-Tech, had no comment about the decision. Abbas Kazerounian, a lawyer in Costa Mesa, California, representing the plaintiffs, said, “We have deep respect for Judge Carter and [are] studying his order in detail while discussing all options with our client.”
All three ingredients highlighted in the complaint have garnered the attention of FDA in warning letters, and two of them have been the subject of litigation in recent years between Hi-Tech and FDA.
FDA has described DMAA as an “amphetamine derivative” that can raise blood pressure and lead to cardiovascular problems such as shortness of breath, tightening in the chest and heart attack.
Last year, in a 2-to-1 decision, a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit affirmed a 2017 district court summary judgment order, which held DMAA is not a dietary ingredient under DSHEA.
“DMAA is not an ‘herb or other botanical,’” District Judge Robert Hinkle wrote in the 11th Circuit’s decision. “It is not a ‘constituent’ of an herb or other botanical. And it is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use.”
The appeals court on April 8 denied Hi-Tech’s request for a rehearing before the entire panel. Jared Wheat, CEO of Norcross, Georgia-based Hi-Tech, said the company “absolutely” plans to file a petition for certiorari with the U.S. Supreme Court. According to Wenik, a member of the law firm Epstein Becker & Green P.C., the petition is not due until Sept. 8.
On April 10, 2019, FDA sent a warning letter to Hi-Tech and several others over the sale of DMHA. On a webpage linking to the warning letters, FDA alleged DMHA is “adulterated” because it’s a new dietary ingredient (NDI) that has not met requirements to be lawfully marketed in supplements.
DMHA may also be an unapproved food additive if it does not qualify as a dietary ingredient, according to the warning letters.
“DMHA it is not generally recognized as safe [GRAS] under its conditions of use in your dietary supplement products,” an FDA official, William Correll, wrote to Wheat in the letter. “If DMHA is not a dietary ingredient under section 201(ff)(1) of the [Federal Food, Drug and Cosmetic] Act, dietary supplements containing DMHA would be adulterated under section 402(a)(2)(C)(i) of the Act because they would contain an unsafe food additive.”
In a May 1, 2019 letter to Correll, Wheat attached a copy of a lawsuit filed in Washington, D.C., that same day against FDA, which alleged the agency was responsible for an “arbitrary and capricious” enforcement action against DMHA.
Referencing an expert report he enclosed, Wheat stated in his letter, “DMHA is a dietary ingredient as defined by DSHEA because it is a constituent of several plants, each of which have long been part of the human diet.”
The expert’s report further concluded “DMHA is safe as its effects have been studied and are well-known, and it does not have a history of AERs [adverse event reports] resulting from its use,” Wheat wrote.
Recently, U.S. District Judge Reggie Walton dismissed the lawsuit against FDA. In a June 29 order, he found he lacked “subject matter jurisdiction over the plaintiffs’ claims” since FDA’s “warning letter is not a final agency action subject to judicial review.”
In an interview, Wheat said he hasn’t heard from FDA regarding DMHA since the warning letter was sent to him.
FDA in 2016 wrote seven warning letters regarding methylsynephrine, also known as oxilofrine. According to FDA, methylsynephrine does not qualify as a dietary ingredient, and labeling it as such causes products marketed as dietary supplements to be misbranded.
“Additionally, methylsynephrine is not approved as a food additive or prior sanctioned for use in dietary supplements,” Correll wrote in the letters. “Further, FDA's review of this substance does not identify a basis to conclude that the substance is GRAS for use in food. If you contend that this substance is GRAS for use in food, please provide your basis for concluding that methylsynephrine is GRAS for use in dietary supplements, including supporting data or other documentation.”
FDA verified in an email that its positions have not changed regarding DMAA, DMHA and methylsynephrine.
Hi-Tech did not receive a warning letter regarding methylsynephrine. Wheat said in an email he “strongly disagree[s] with FDA’s position” because the ingredient “is in various plants.”