Did You Purchase Axona Or Glucorein?

MIAMI, FL, March 27, 2014

The FDA has asserted that Axona and Glucorein are falsely advertised as "medical foods" when in fact they should be considered prescription drugs. Both drugs have been misbranded by their makers, deceptively leading consumers to believe that the products are something they are not.

In a letter dated December 26, 2013, the FDA warned Accera, Inc. that the labeling of its Axona product was false and misleading. According to Accera, Axona is intended for the "management of the metabolic processes associated with mild to moderate Alzheimer's disease," but according to the FDA, mild to moderate Alzheimer's disease has no distinct nutritional requirements that would warrant a product labeled as a medical food for its treatment or control.

In a similar letter sent to NVN Therapeutics, also dated December 26, 2013, the FDA warned NVN that the labeling of its product, Glucorein, was false and misleading. Glucorein is advertised for the treatment of Polycystic Ovary Syndrome (PCOS). But, like Alzheimer's, PCOS has no unique nutritional requirements for those diagnosed.

According to the FDA, both Axona and Glucorein are misbranded health products. Both are "new drugs" according to the 2013 warning letters and both have been illegally marketed without receiving prior approval by the FDA. The FDA requires evidence of a drug's safety and effectiveness be presented when considering whether a new drug should be approved. Neither Axona nor Glucorein have been approved for use as a drug.

What Is A Medical Food?

A medical food is not the same thing as a dietary restriction or suggested meal plan. Using a product properly marketed as a medical food is not the same as taken in an appropriate amount of fruits and vegetables to maintain a healthy diet. A medical food is taken at the direction of a treating physician to treat or manage a serious health problem, like Alzheimer's disease or PCOS.

The full definition of medical food can be found in the Orphan Drug Act. [See 21 U.S.C. Sections 360ee(b)(3) or 21 C.F.R. 101.9(j)(8)]. In short, a medical food is:

- Intended for oral consumption
- Not naturally occurring; it is a specially-formulated and/or processed product
- Responsive to the unique medical needs of a specific disease or medical condition
- For use only under the supervision of a health care professional, although they do not require a prescription

The FDA has taken a very narrow view of what actually qualifies as a medical food, perhaps because there is no pre-approval process for these products before they are marketed to consumers. Often, the first correspondence that a company will receive related to a misbranded medical food is the enforcement letter from the FDA alerting the company that its product is falsely labeled.

What Does This Mean To You If You Have Taken Glucorein Or Axona?

If you or a loved one purchased Glucorein or Axona, you may have a legal claim against NVN Therapeutics or Accera, Inc.Falsely advertising a product as something it is not (a medical food) or selling a product for an unapproved use (as a new drug) may give rise to compensation for those who purchased the product based on the misleading or deceptive advertising.

If you suffer from PCOS and have tried Glucorein or if you or a loved one has used Axona to control mild to moderate Alzheimer's, contact the South Florida law firm of Freidin, Dobrinsky, Brown & Rosenblum today to discuss whether you have a false advertising claim against the companies involved. With offices in Miami, Ft. Lauderdale and Fort Myers, the firm offers a free consultation to anyone with questions about Axona or Glucorein.

We can provide transportation to our offices, and we are willing to meet with you at any location.

About The Firm:

The South Florida trial lawyers of Freidin, Dobrinsky, Brown & Rosenblum P.A. have been helping individuals secure compensation after the negligence, recklessness or bad acts of another forces them to deal with serious personal injury. After more than 300 jury trials and a history of successful personal injury lawsuits, Freidin, Dobrinsky, Brown & Rosenblum P.A. focuses on providing quality legal services to each and every individual and family we work with.