REGION — What are you getting in the many food supplements available today; who is overseeing their contents and how well the public is being protected?

As widely reported (see e.g. our editorial of February 12), the New York Attorney General’s office in February ordered four major retailers—Walmart, Target, Walgreens and GNC—to stop selling “adulterated” and “mislabeled” herbal supplements that independent lab tests showed do not contain ingredients as stated on the labels. Published reports charged that “Seventy-nine percent of them either didn’t contain the stated ingredient(s), or were contaminated by other filler materials such as rice and wheat to which some people might be allergic.”

According to the online publication The Hill, immediately following the New York announcement several U.S Senators, said to have long advocated for “stronger public protection against food supplements,” called for a nationwide investigation by the U.S. Food and Drug Administration (FDA). (See: tinyurl.com/lltntqy).

In October of 2012, the FDA issued a six-page warning letter to the manufacturer of Prevagen, Quincy Bioscience, of Madison, WI. Prevagen is a popular and widely marketed food supplement, which claims to safely enhance memory (tinyurl.com/c85yojz).

Among numerous charges, FDA contended that Quincy synthesized a protein originally found in jellyfish, apoaequorin, which is the basis of Prevagen, rather than taking the natural substance. With synthesizing, FDA found that the product becomes a drug subject to the various trials that all new drugs must complete before marketing. FDA found that Quincy is in violation of the federal Food, Drug and Cosmetic Act, since Prevagen has not undergone this testing.

Further, Prevagen advertised then and continues to claim that the product is safe to use, but FDA wrote that Quincy “failed to report to FDA adverse events like seizures, strokes and worsening symptoms of multiple sclerosis that had been reported to your firm as being associated with use of Prevagen products.”

FDA also listed other health issues including “heart arrhythmias, chest pain, vertigo, tremors and syncope (fainting).”

FDA also claimed a violation in Quincy’s publication of user testimonials related to dementia and Alzheimer’s disease. FDA considers this as “a claim about disease treatment or prevention,” which is prohibited without FDA approval.

A December, 2013 story in the Madison newspaper Isthmus continued the story (tinyurl.com/mj676j7.)

The story’s lead reported that the company has “all but settled its problems with” FDA.

Quincy President Mark Underwood confirmed some of the “reporting issues” FDA spoke of, but went on to say, “We’ve been able to satisfy all of their requests.”

However, he denied any connection between his product and the reported health issues, saying that Prevagen’s target market is aging and older people who often have unrelated medical issues.

The story also reported that after 14 months, FDA still said the case remained open and declined to clarify that position.

Underwood said then that of 72 warnings issued in October of 2012, only 16 have since been closed.

Last month, then 29 months after the warning letter was issued, an FDA, spokesman in Washington, DC essentially gave The River Reporter the same comment, that the case is open and that all of the warning letter’s claims remain valid.

TRR also contacted Underwood, who expressed surprise about the FDA comment and said Quincy had considered the issue closed and that Quincy “has not been apprised,” of their continuing concern.

Echoing his remarks to the Isthmus, he went on to claim that only 5% of FDA warning letter cases ever result in a closure letter, formally ending the case.

Given his claim that FDA and his company resolved their issues, Underwood was asked if his company has suffered damage from the continuing lack of closure. While he said it was likely, he would not comment on any legal action that his company was considering against FDA.

Two and half years have passed since FDA cited health dangers related to this product. In that time thousands of people, often desperate for help with memory issues, have continued to buy Prevagen—most of them unaware of FDA’s apparently continuing legal and health concerns about it.

TRR asked members of Congressional oversight committees why after all this time, Prevagen’s saturation TV advertising is still allowed to simply call the product “safe.”

Is the FDA delay—29 months—in disposing of this issue without further public notification, warning, or clarification of the issue acceptable?

What level of oversight for FDA does Congress maintain, and is Congress doing its job?

Neither Sen. Bill Nelson (D-Fla.) who chaired the Senate’s Sub-Committee on Consumer Protection, Product Safety and Insurance until January of this year, nor Rep. Eliot Engel (D-NY-16) of Bronx and Westchester counties), a senior member of the House Sub-Committee on Health, have replied to our questions.