By Josh Long, Legal and Regulatory Editor

WASHINGTON Quincy Bioscience recently announced being included in the Inc. 500 list of fastest-growing companies in the U.S. and celebrating the fifth anniversary of a brain vitamin that is said to improve short-term memory.

But the biotechnology company could find it challenging to maintain its robust growth. In a warning letter sent to Quincy Bioscience, FDA raises a number of red flags that could foreshadow serious enforcement action, some industry lawyers who do not represent the company said.   

The company's brain vitamin, "Prevagen", is touted as a supplement that "can provide a healthier brain, sharper mind, and clearer thinking." Quincy Bioscience asserts a three-month study of participants over the age of 40 who were suffering from memory problems showed significant improvements in such areas as learning, short-term memory and word recall. The company also features video testimonials on its website from consumers who tout the benefits of Prevagen, which is sold at major U.S. retailers including CVS Pharmacy and Walgreens.

"I went through chemotherapy this past year, which can really fry your brain. But I would recommend it [Prevagen] to people because I went to my oncologist with it and said, 'is it OK if I take this,?'" Sue Baumer said in a testimonial. "And he's real not into nutrition, you know how they are, those Western doctors. But he said, this looks OK. Fine, yeah, go ahead. It can't hurt you."

That testimonial may be misleading.

Quincy Bioscience Fails to Report Adverse Effects

Reports of chest pain, tremors, fainting and much worse symptoms have been associated with the vitamin. In a recent warning letter, the FDA pointed out Quincy Bioscience neglected to tell it about "adverse events like seizures, strokes, and worsening symptoms of multiple sclerosis that had been reported to your firm as being associated with the use of Prevagen products."

In fact, of more than 1,000 incidents and product complaints reported to Quincy Bioscience between May 2008 and December 1, 2011, the Madison, Wis.-based biotechnology company had only investigated or reported two events at the time government regulators inspected its facility at the end of the year, according to the warning letter.

Some of these incidents led to hospitalization, and while FDA's inspection was in progress, Quincy Bioscience reported additional "serious adverse events" to FDA, the agency disclosed. Early this year in a response to FDA, Quincy Bioscience released reports on "adverse events" that it "determined to be serious" as well as a revised procedure for documenting and judging the severity of the incidents plus paperwork in connection with employee retraining, wrote an FDA official in Minneapolis.

Still, the company indicates on the "FAQs" page of Prevagen's website there are no adverse side effects. "Prevagen has been independently tested and shown to be non-toxic and well tolerated." The same page also declares there are "no known interactions" when asked whether Prevagen is safe to take with other medications, although the website recommends a consultation with a doctor before taking it.

Marc Ullman, a food and dietary supplement lawyer in New York, said FDA has discretion to bring a criminal action for failure to report "serious adverse events". Justin Prochnow, a Colorado-based food and dietary supplement attorney, said the omission constitutes a "prohibited act" under federal law and includes maximum penalties of up to $1,000 per act or up to one year behind bars.

"FDA has used such failures in the past when seeking an injunction to shut a company down," noted a veteran food and dietary supplement attorney in Washington, D.C. who didn't want to be identified.

The reporting requirements became effective about four years ago under the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Among other things, the statute defines a "serious adverse event" to include "inpatient hospitalization", "a life-threatening experience" and "a persistent or significant disability or incapacity".

What FDA didn't make explicit in the warning letter is the number of "serious adverse events" that Quincy Bioscience failed to disclose. "If someone reports they got dizzy, that's an adverse event but it wouldn't fall under the requirements of serious adverse event reporting," Prochnow said.

Mark Y. Underwood, the president of Quincy Bioscience, on Tuesday declined to comment on FDA's warning letter. "Right now we are still working on our response to the Agency so I am not free to comment publicly," he stated.

Company Faces More Hurdles

The Madison, Wis.-based company has plenty to account for. Although Prevagen products are labeled as dietary supplements rather than drugs, FDA has accused Quincy Bioscience of promoting the products for conditions that make them drugs under federal law. To make matters more complicated for Quincy Bioscience, FDA contends Prevagen isn't a dietary supplement even if it wasn't intended to cure, mitigate, treat or prevent a disease. That's because the government has found the product no longer contains a dietary ingredient since a protein known as apoaequorin is produced synthetically rather than extracted from jellyfish.

"Apoaequorin synthetically produced from (b)(4) is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, apoaequorin synthetically produced from (b)(4) is not a concentrate, metabolite, constituent, or extract of any dietary ingredient, nor is it a combination of dietary ingredients," FDA explained in the warning letter. "Therefore, the synthetically produced apoaequorin used in your Prevagen products is not a dietary ingredient as defined" under federal law.

The company, Ullman said, "may have in effect frozen themselves out of the supplement market."

Quincy Bioscience has even more explaining to do. On a website www.hopetrials.com, Quincy Bioscience has described clinical trials that were conducted to study apoaequorin for use in treating or preventing diseases, according to FDA. That wouldn't be a problem except for one fact: doing so without an investigational drug application or so-called INE violates federal law, the agency said. And despite promising corrective action earlier this year, the agency wrote that Quincy Bioscience continues to use apoaquorin in clinical trials without the proper application.

Another 2011 inspection of the company's facilities in Middleton, Wis. discovered a number of violations of current good manufacturing practice regulations. FDA acknowledged Quincy Bioscience has taken some remedial action but the agency indicated its response was inadequate because FDA has determined the Prevagen products are drugs rather than dietary supplements.

On its website, Quincy Bioscience asserts its "Quality Assurance Department is fully compliant with current Good Manufacturing Practice (cGMP) standards as defined in federal code by 21 CFR 111." FDA obviously has adopted a different position.