Prevagen Charged by FTC for Making False Claims

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Prevagen Charged by FTC for Making False Claims

The marketers of popular brain supplement, Prevagen, have been charged with making deceptive and unsubstantiated claims regarding memory and improved cognitive improvement according to Stephen Daniells of Nutra Ingredients.

Quincy Bioscience ran many national advertising campaigns claiming its Prevagen product is the answer for those looking to improve memory and cognitive function. The Federal Trade Commission (FTC) and New York State Attorney General Eric Schneiderman criticized the supplement maker for preying on older consumers looking to curb age-related memory loss.

In a statement, Quincy Bioscience responded to the complaint by alleging the FTC and NY AG are overstepping their boundaries. They also claim they have a “large body of evidence” that Prevagen improves memory. They also assert their studies were randomized, double-blind, placebo-controlled human clinical trials; which is what the Food and Drug Administration (FDA) requires.

Despite having studies available on their website, data regarding significant results were not observed during the study of healthy or mildly-impaired participants.

The FTC responded by clarifying that the clinical studies are not the issue, but that interpretation of results used do not present conclusive evidence to substantiate their marketed claims. Attorney General Eric Schneiderman takes issue with the claims that the active ingredient, apoaequorin (a protein from jellyfish), reduced memory problems associated with aging.

In 2012, Quincy Bioscience received a warning letter from the FDA alleging apoaequorin was an unapproved new drug. The FDA asserted that apoaequorin is synthetically produced and is not a vitamin, mineral, amino acid, herb, other botanical, or dietary substance for use by man to supplement the diet through daily intake. It is not a concentrate, metabolite, constituent, or extract of a dietary ingredient or combination of dietary ingredients. By not meeting any of those definitions, apoaequorin is not a Dietary supplement ingredient.

Quincy Bioscience submitted a New Dietary Ingredient (NDI) submission, but the FDA was unable to establish a safety profile of the ingredient based on provided toxicology data or ingredient history of use. Quincy Bioscience submitted a Generally Regarded as Safe (GRAS) notification and a third-party panel agreed that no adverse effects were observed, thus the experts agreed on apoaequorin’s safety.

Essentially, Quincy Bioscience was trying to pass off a synthetic ingredient as a Dietary Supplement and was caught. While the ingredient was found to be safe, it still could not be used. Quincy Bioscience’s request, the GRAS submission was withdrawn.

Unsubstantiated marketing claims and adulterated batches make up the bulk of the FDA’s intervention. Dietary Supplement manufacturers looking to expand their quality process should check out InstantGMP™ MES. Our software has helped numerous firms reduce their compliance woes and take their product quality to the next level. Sign up for a free demo and we’ll show you how it’s done.