Hi-Tech Pharmaceuticals Sues The FDA For "Bullying Tactics"

ATLANTA, Nov. 18, 2013 /PRNewswire/ -- Hi-Tech Pharmaceuticals sued the FDA November 5th, 2013 in Federal Court- Case 1:13-cv-01747, claiming the agency bypassed standard rule-making procedures in favor of a bullying campaign to try to force companies to destroy their products containing 1,3 dimethylamylamine, or DMAA. "DMAA has existed in the food supply for many years," the complaint states. "Hi-Tech has sold over a million bottles of dietary supplement products containing this ingredient without any adverse event reports."

Hi-Tech calls DMAA a natural constituent of the geranium plant. It claims that geraniums are used in salads and its oil as a flavoring. "No less than four published, peer-reviewed scientific studies have confirmed the presence of DMAA in the geranium plant. Large, established reputable laboratories such as Cantox Health Sciences International have confirmed the presence of DMAA in the geranium plant," the complaint states.

Hi-Tech claims the FDA's efforts to eradicate DMAA from the market exceeds its authority and violates the Administrative Procedures Act. "Under the pretext that DMAA-containing products pose a danger to consumers, the FDA has engaged in a campaign of intimidation against dietary supplement companies like Hi-Tech who include this ingredient in their products," Hi-Tech says in its lawsuit. "For some companies this has taken the form of warning letters and pressure by the FDA to remove and destroy DMAA containing products. In the case of Hi-Tech, the FDA has issued an administrative detention order against numerous proprietary dietary supplement products without notice, essentially removing millions of dollars in goods from the marketplace."

Hi-Tech adds: "By its own admission, the FDA has declined to engage in the rule making process necessary to formally ban DMAA. Thus there has been no public discussion or comment regarding the scientific evidence regarding DMAA and its safety." Hi-Tech says it wants the "FDA's campaign of intimidation" stopped by the court, and that "if the agency has scientific evidence which brings the safety of DMAA into question, that it disclose same and engage in the formal rule making process to ban the ingredient."

The FDA has rested its very, very shaky case on a false premise, or misguided hope, that DMAA is not found in geranium since they first sent out the original warning letters in April 2012, and that synthetic analogues of naturally occurring consumables would never qualify as a dietary ingredient. This willful misinterpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) comes directly from the FDA's NDI Draft Guidance.

For the FDA to assert that no synthesized natural compound could ever be a dietary supplement is tantamount to saying that the vast majority of all dietary supplement products on the market today are adulterated. FDA has a long history of recognizing that synthetic ingredients identical to natural ingredients should be treated the same. FDA's nutritional labeling regulation states that a food is deemed misbranded if its labeling states or implies "That a natural vitamin in food is superior to an added or synthetic vitamin. 21C.F.R. § 101.9(k)(4). This prohibition dates back to the late 1960s, when the agency vigorously defended its position on this issue during two years of public hearings on special dietary food regulations.These hearings took place between 1968 and 1970. See 38 Fed. Reg. 2143,2147, 2150 (January 19,1973). At the end of the rulemaking process, FDA concluded that "There is no nutritional difference between a vitamin provided by a synthetic source and the same vitamin provided by a natural source…."

As recently as the late 1990s, FDA reaffirmed the validity of the prohibition on distinguishing between natural and synthetic ingredients, stating that it is "aware of nothing that establishes that a claim between the difference between the natural and synthetic version of the same form of a nutrient is not misleading."62 Fed. Reg. 49826, 49841 (September 23, 1997). Denying the validity of synthetic botanical extracts would suggest FDA now views a material distinction between synthetic and natural versions of the identical ingredients. This approach towards DMAA is arbitrary and intellectually dishonest in light of the agency's consistent historical policy.

Several concrete examples illustrate that FDA recognizes the equivalence of naturally extracted sources and synthetic counterparts of dietary ingredients. FDA has affirmed as GRAS both natural and synthetic riboflavin,21C.F.R. § 184.1695(a). vitamin A,21C.F.R. § 184.1930(a).and vitamin D 21C.F.R. § 184.1950(a). FDA approved the food additive Vitamin D3 in both natural and synthetic forms.21C.F.R. § 172.380(a). FDA has previously acknowledged the breadth of Section 201(ff)(1)(E) in the preamble to its regulation on requirements for nutrient content claims, health claims, and statements of nutritional support for dietary supplements. 62 Fed. Reg. 49859, 49860 (September 23, 1997). There, the agency stated in a Federal Register preamble-which constitutes a formal agency advisory opinion- 21C.F.R. § 10.85(d)(1). That a substance such as CoQ10-which occurs naturally in tobacco, soybean oil, olive oil, and parsley is also commonly synthesized- falls within the broad range of dietary ingredients that Congress contemplated. Id.(quoting from the legislative history of "other nutritional substances"—a precursor to "dietary ingredients"—statements that numerous ingredients not traditionally or historically viewed as food substances would be included, such as primerose oil, black currant seed oil, etc.

Hi-Tech is determined to force FDA to follow the law and stop its "Bullying Tactics". If FDA is allowed to run amok and continue to "Bully" ingredients that they do not like off the market, then the dietary supplement industry will cease to be able to give consumers ingredients they desire, such as DMAA, that has been proven safe and effective.

CONTACT: Jared Wheat, 888-855-7919 x301

APRIL 2015 Update:

A federal judge in Georgia denied a request by the U.S. government to dismiss a lawsuit filed by Hi-Tech Pharmaceuticals Inc., a dietary supplement manufacturer that contends FDA unlawfully detained millions of dollars in products that contained a controversial substance.

While supplement companies seldom contest FDA’s enforcement decisions, Hi-Tech hasn’t been reluctant to challenge federal authorities. On Wednesday, FDA demanded that Hi-Tech (and four other companies) cease distributing supplements containing a substance known as BMPEA because the products are misbranded, an allegation Hi-Tech vigorously denied.

The ongoing DMAA dispute before U.S. District Judge Willis B. Hunt, Jr. puts the spotlight on competing forces: FDA’s duty to protect the public health and centuries-old requirements to afford companies due process of law before taking property.

Georgia-based Hi-Tech is immersed in a 17-month-long court battle with FDA on whether the public health agency, in its efforts to remove 1, 3 dimethylamylamine (DMAA) from the U.S. market, improperly skirted the 21-year-old law governing the multibillion-dollar supplement industry.

Through an administrative detention order, Hi-Tech has complained, FDA effectively removed its products from the market without going through a rulemaking or making any factual findings. Lawyers for the company argued FDA couldn’t ban DMAA unless it engaged in the rulemaking procedure. FDA has only done so once under the 1994 Dietary Supplement Health and Education Act (DSHEA), when it excluded from the market ephedra-containing supplements more than a decade ago.

August 2015 Update:

“ORDER: the Government’s motion to strike, ^[37], is DENIED. The Government’s motion to dismiss, ^[43], is DENIED without prejudice. Hi-Tech’s motion to stay, ^[46], is GRANTED. The parties are DIRECTED to confer and to present to this Court, within two weeks, a proposed scheduling order that provides a timetable for further discovery and the filing of the Government’s motion for summary judgment and the subsequent pleadings discussed above.

Signed by Judge Willis B. Hunt, Jr., on 4/21/15. (jta)”

This order, written by Judge Willis B. Hunt, Jr., DENIES all motions of the US Government to strike and dismiss this case. He states that “it is clear that certain evidentiary issues need to be developed”, and then orders the two parties to set a timetable for discovery and to begin filing motions for the court case.

In short: this case is going to court, get ready to play ball!

What’s next?

We expect this suit to go into 2016 and beyond, and will post any updates when possible. Make no mistake: simply having the court case not get thrown out is a major victory, and signals that the judge sees at least some kind of merit to Hi-Tech’s arguments.

Until more happens, we fully expect Hi-Tech to continue to sell their DMAA-based supplements, until “Final Agency Action” is declared, as will likely be decided by this court case.

Remember where the burden of proof lies

A major thing not discussed here at length is the burden of proof. As DSHEA is written, the burden is currently on the FDA to prove that a compliant supplement is dangerous or adulterated (Section 402 (21 U.S.C. 342)).^[10] On occasion, the FDA (and often the FTC) seemingly try to circumvent this law through various means, such as those discussed in Hi-Tech’s original lawsuit against them. That is why the court system exists – to solve, rule, and judge how the law is to be applied.

The FDA says “No, you prove it.” USP says “Here’s proof. You prove that it isn’t.” Then the FDA says “That proof isn’t good enough. Here’s some other geranium plants that don’t have it.”

This can go on forever.^[7]

Hi-Tech’s legal team has already won some major decisions – we can’t believe it’s easy to get a judge to publicly slap such a large government agency, as was the case in Document 4. In that regard, we consider it to be progress.

Interesting strategic differences

So far, we’ve noticed that Hi-Tech’s lawyers and the Judge both write their arguments and statements in clear and concise English that nearly any high school graduate can understand. The US Government’s lawyers, however, are writing their arguments in extremely difficult-to-understand, bureaucratic-driven verbiage. It is basically incomprehensible for an untrained eye.

Perhaps this is how all of the US Government Agency’s legal writing sounds, but it doesn’t seem like this particular judge cares too much for it.

For whatever reason, we get the impression that the FDA did not want to take this to court. That’s often the case for anyone, mind you – court cases are expensive and time-consuming. But with this judge, Hi-Tech Pharma will apparently get at least some chance at a fair fight, and that’s about all anyone in the industry can ask for.

Got your popcorn ready?

Hi-Tech doesn’t seem to pick many fights that they can’t win. This is not the first time they’ve stood up for the industry and proper enforcement of DSHEA. No doubt, they’re a polarizing company, but being polarizing doesn’t mean that you don’t deserve your day in court just like anybody else.

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