Hi-Tech Lawsuit Calls FDA DMAA Enforcement “Bullying Tactics”

Hi-Tech Pharmaceuticals files a lawsuit in federal court after receiving an administrative detention order from FDA to stop distributing its DMAA-containing products. The firm argues FDA should conduct a rulemaking to propose banning DMAA rather than ordering firms to stop using it.

Hi-Tech Pharmaceuticals Inc. argues that FDA must follow the rulemaking process if it intends to ban the use of DMAA in dietary supplements, saying the agency used a “campaign of intimidation” to force firms to cease manufacturing products with the ingredient.

Hi-Tech is litigating to stop FDA’s enforcement against products containing dimethylamylamine, or DMAA, an ingredient used primarily in strength training that the agency has linked to cardiovascular problems. The firm filed a lawsuit Nov. 5 in the U.S. District Court for the District of Columbia after FDA imposed an administrative detention order on Nov. 1 to stop distributing its products.

While numerous firms have marketed DMAA-containing products, Hi-Tech appears to be alone in fighting FDA in court over the ingredient.

Hi-Tech contends the agency should conduct a rulemaking to propose banning DMAA rather than ordering firms to stop using it, alleging that FDA’s efforts to ban its use exceed agency authority and violate the Administrative Procedures Act.

The firm also argues that DMAA qualifies for use in supplements as a natural constituent of the geranium plant, and is a dietary ingredient that was in use prior to the Dietary Supplement Health and Education Act grandfather date of October 1994. FDA rejects the contention, arguing that DMAA is not a dietary ingredient, and thus not eligible for use in supplements.

Using the rulemaking process to effect the ban of an ingredient likely would take years.

Hi-Tech is intent on stopping FDA’s “bullying tactics,” the firm said in a Nov. 14 release announcing the suit. FDA sent warning letters to some manufacturers, but the agency exercised an administrative detention order against Hi-Tech without notice, the firm noted.

“Something People Shouldn’t Eat”

U.S. Marshals Service officers on Nov. 12 seized more than $2 million worth of finished DMAA products and raw materials from Hi-Tech’s Norcross, Ga., manufacturing facility. FDA requested the seizure after filing a complaint in U.S. District Court for the Northern District of Georgia alleging the products are adulterated because they contain DMAA, which the agency has deemed unsafe.

The agency’s action stems from an October inspection of the Norcross plant where FDA found bulk DMAA raw ingredients and 11 products labeled as containing the ingredient or its chemical equivalent.

FDA’s supplement program head defended the agency’s actions at Virgo’s SupplySide West expo and conference in Las Vegas.

Hi-Tech “supposed that we had to send them a warning letter first. We don’t,” said Division of Dietary Supplement Programs Director Daniel Fabricant Nov. 14. “We have given prior notice on how we feel about” DMAA in supplements.

“It is not an ingredient that should be out there. Unfortunately, some people want to keep fighting on this. … While that is a waste of our resources, it is worthwhile to do what we can to get this out of commerce,” Fabricant added.

In alleging FDA failed to follow regulatory procedures before banning DMAA, Hi-Tech says “there has been no public discussion or comment regarding the scientific evidence regarding DMAA and its safety.

At SSW, Fabricant said FDA’s determination that DMAA is not a dietary ingredient trumps any argument that the agency should propose a rule to ban its use in supplements. Rulemaking is “an interesting idea,” but DMAA “is not a dietary ingredient, so I don’t know what we should ban it as – something people shouldn’t eat?”

The agency initiated its DMAA enforcement in April 2012 with warning letters to 10 companies marketing products containing the compound. The agency also has posted consumer alerts stating DMAA can elevate blood pressure and lead to cardiovascular problems (Also see "FDA Using “All Available Tools” To Remove DMAA From Market" - Pink Sheet, 15 Apr, 2013.).

Hi-Tech Flying Solo

Hi-Tech appears to be alone in suing to stop the agency, as other companies that previously marketed DMAA supplements already halted distribution, most without contesting FDA’s warnings.

“It’s not insignificant that the entire industry has virtually abandoned DMAA but for a few folks like Hi-Tech,” said attorney Jonathan Emord, president of Clifton, Va.-based Emord & Associates.

Most other DMAA product firms probably conferred with legal counsel and were told, “this was one not worth fighting over,” said Emord, who represented firms that sought to contest FDA’s 2004 ban on using ephedra in supplements.

“I think the better part of valor is not to fight on this one,” he said. The suit is “an unlikely case to win” and could put Hi-Tech in a precarious position.”

Emord pointed out another strike against the argument for using DMAA in supplements: its history as a drug compound that Eli Lilly & Co. patented more than 50 years and later marketed as a nasal decongestant before withdrawing it in 1983 due to significant side effects including headaches and increased blood pressure.

DMAA is a vasoconstrictor and bronchodilator in its physical effects, which “are definitely deemed by FDA to be drug effects,” Emord said.

If a court finds DMAA is a drug and products containing it are misbranded and sold as unapproved drugs, the ruling could lay the foundation for criminal prosecution. “So you could actually be inviting your own demise by going forward with a case like this,” Emord said.

Hi-Tech and founder and CEO Jared Wheat are not strangers to conflict with FDA. Wheat and three employees in 2008 pleaded guilty to charges including conspiracy to import and distribute adulterated, mislabeled and unapproved new drugs and committing mail and wire fraud associated with the firm's counterfeit Rx drug operation. Wheat was ordered to 50 months in prison and a $3 million fine (Also see "Hi-Tech Prosecution Offers FDA Model For Pursuing Bad Actors – Lawyer" - Pink Sheet, 25 Aug, 2008.).

[USPlabs LLC] also tried to convince FDA of DMAA’s safety, but stopped short of filing litigation. The Dallas firm in April 2013 said it would stop using DMAA in its products as FDA concluded DMAA is not a dietary ingredient and would be rejected as the subject of a new dietary ingredient notification (Also see "FDA Ushers Out Known DMAA, Closes Dietary Ingredient Door" - Pink Sheet, 22 Apr, 2013.).

In July, USPlabs destroyed DMAA-containing supplements worth more than $8 million, but attracted additional enforcement action after reformulating its OxyElite Pro supplements with aegeline. FDA notified the company Nov. 6 that the supplements have been linked to liver illnesses in multiple states. FDA sent USPlabs an Oct. 11 warning letter that the OxyElite Pro and its Versa-1 supplements are adulterated because they contain aegeline, which lacks a history of use or other evidence of safety (Also see "DMAA Product OxyElite Pro Named Potential Link In Acute Hepatitis Cases" - Pink Sheet, 9 Oct, 2013.).