FDA Warning Letter To Prevagen: Unapproved Drug Claims
Written By Kobi Nathan, Pharm.D., M.Ed., CDP, BCGP, AGSF
Sleep Disorders
September 22, 2021

Updated January 31, 2023

FDA Warning Letter To Prevagen: Unapproved Drug Claims

Prevagen, one of several brain health supplements, contains the dietary ingredient apoaequorin, a jellyfish protein that has no relationship to age-related memory loss or brain function. 

Prevagen has a questionable track record and pushes false and misleading claims, preying on the fears of older consumers.

Severe adverse events were left out of reporting to the FDA by the makers of Prevagen, prompting the filing of a lawsuit by the Federal Trade Commission (FTC).

Many Americans are concerned about the effects of aging on memory.

Specifically, there is anxiety and a real palpable fear among some middle-aged and older adults that they may develop cognitive impairment or Alzheimer’s disease.

The hope of staving off this decline, and maintaining a healthier brain and a sharper mind drives the highly profitable dietary supplement industry in the U.S.

Some examples are bacopa, vinpocetine, huperzine, ginkgo, etc. All of these have shown mixed, variable results.

The current scientific literature does not support the use of any of these supplements to assist in improving memory and learning.

Almost daily in my geriatric assessment clinic, my patients ask me about Prevagen, and whether it has convincing evidence that suggests it will help improve their memory.

When they do internet searches, they are presented with mixed information.

Some websites and posts suggest that the dietary supplement shows promising results and users experience significant cognitive benefits, while others list complaints associated with prevagen.

This post hopes to answer all of these questions and dive into some of the controversies surrounding this supplement. So, does Prevagen help improve memory? Let’s dive right in to find out…

What Is Apoaequorin?

The main ingredient in Prevagen is a calcium-binding protein called apoaequorin, originally derived from jellyfish [Note: the apoaequorin found in Prevagen is synthetically produced in a lab, and this is what got the manufacturer in hot water with the Food and Drug Administration (FDA) because they were essentially marketing an unapproved new drug].

So, the logical question is, what is the relationship between apoaequorin and human brain function?

The general idea is that since the brain also contains calcium-binding proteins that play a crucial role in healthy brain function and other aspects of cognitive function, it stands to reason that taking apoaequorin may prevent damage to these brain cells and keep them healthy.

It then follows that consumers who take Prevagen may see a significant improvement in mild memory loss, purportedly, allowing consumers to lead a better life.

Maybe this might be so when this is done to cell cultures in dishes in the lab.

It is also important to note that the rat studies that showed positive results had researchers INJECT the apoaequorin directly into their brains! We can safely say that no sane human would ask their doctor to inject this protein into their brain!

If injection into the brain is not an option, then the next logical step would be to take this protein orally.

However, this potential workaround presents one major and crucial problem: Apoaequorin, a protein, would almost instantaneously be broken down by stomach acid into amino acids and peptides.

Hence, none of this protein would even make it out of the stomach intact to be transported to the brain, where it is supposed to have its positive effect.

The supplement manufacturer states that the active ingredient is broken down in the digestive tract in its much-hyped Madison Memory Trial!

Even if all of the above were not true, here’s another kicker: the apoaequorin protein is too big to pass through the natural barrier that keeps blood separate from the brain, and will fall short of entering the brain anyway!

So apart from the company’s own questionable trial, there are no peer-reviewed publications from reputable medical journals that prove that Prevagen improves memory, despite their seeming carefully worded language to suggest that they adhere to the scientific process.

For these reasons, medical experts widely agree that there is no known role for apoaequorin in improving human memory.

Is Prevagen FDA Approved?

No, it is not. The FDA does not regulate Prevagen because it is a dietary supplement. It is not intended to diagnose, treat, cure, or prevent any disease.

Controversies and Side Effects Of Taking Prevagen – FDA Warning, FTC Lawsuit, and Class Action Lawsuit

The FDA issued a warning letter to Quincy Bioscience, the marketers of the dietary supplement Prevagen on October 16, 2012, stating that the company’s product claims violated FDA regulations.

Specifically, the agency stated that the company made misleading statements that Prevagen is “clinically proven” to improve memory and cognitive function.

Additionally, since the apoaequorin in prevagen products is produced synthetically.

Hence, by federal regulations, it must be marketed as a drug, not as a dietary supplement. No approval has ever been sought by the manufacturer to market Prevagen as a drug, which is a violation of federal law.

Additionally, the FDA found serious issues with adverse event (An adverse event is any undesirable experience associated with the use of a medical product in a patient) reporting by the supplement manufacturer. This is opposite to their statement asserting that their product is safe.

In its 2012 warning letter, it was noted that the company failed to report serious adverse events to FDA.  These events included seizures, strokes, and worsening symptoms of multiple sclerosis. Some of these adverse events resulted in hospitalization for some users.

Specifically, the FDA found records of more than 1000 adverse events and product complaints reported by individuals between May 2008 and December 1, 2011.

The following serious adverse events were identified: Heart arrhythmias (heart rhythm issues), chest pain, vertigo, tremors, and syncope (fainting), in addition to the seizures, strokes, and worsening of multiple sclerosis already mentioned.

Quincy Bioscience only investigated or reported two of these adverse events to the FDA at the beginning of the inspection.

Accordingly, the FTC and the New York State Attorney General filed a lawsuit against Quincy Bioscience. In addition to this litigation, a class action lawsuit was filed, and a settlement agreement was reached on November 18, 2020.

Does Prevagen Improve Memory?

In a nutshell, No.

We know from our discussion above that the company states that improvements in memory were reported after study participants were administered the supplement.

What the website failed to mention transparently on that page, is that this study was company-sponsored.

In the Medical and Pharmacy world, red flags go up whenever we see the results of a company-funded study being reported in a favorable light.

This is because there will always be an inherent bias in the reporting of these studies.

The company’s main goal would be to maximize profits from the sales of its product and minimize any information that could be viewed in a negative light.

The company-sponsored study seeks to prove to the reader that Prevagen works very well. There are graphs that show increases in “memory tasks” from 5% to 10% to 20% over 90 days.

As Dr. Robert Shmerling, Senior Faculty Editor at Harvard Health Publishing Health states, these numbers prove nothing.

He mentions that there is no context for these numbers – what exactly are they referring to?

How many participants were included in the analysis? Were there any other details? What about a follow-up after 90 days?

In addition to the above concerns, Dr. Shmerling also notes that the published version of this study didn’t show any benefit to participants’ memory.

So, does Prevagen Help Improve Memory? The overwhelming evidence from multiple sources is clear: It does not.

Summary of the “Clinical Trial” by Quincy Bioscience: The Madison Memory Study

218 adults between the ages of 40 and 91 participated in this company-sponsored “Madison Memory Study.”

The study investigators’ primary objective was to assess apoaequorin’s effectiveness in improving memory and cognitive function.

The secondary objective was to assess the supplement’s effect on sleep, energy, and quality of life.

Study participants were randomly assigned to one of two groups.

One group received 10mg of apoaequorin, and the other received a placebo (a similar-looking pill with harmless, inactive filler material).

Before starting the trial, participants completed the AD8 Dementia Screening Interview and took the computerized Cog State Research Battery. These tests were repeated again on days 8, 30, and 90.

Then, during the trial, the study participants were tested on their delayed recall (memory) and executive functioning (more complex tasks such as planning, and problem-solving when presented with an unexpected immediate problem).

The tools used to measure these were the Groton Maze Learning, and Groton Maze recall tasks.

Using these tools, the study investigators reported improvements in these areas.

Another tool, the International Shopping Recall List, was used to measure verbal learning (the process of acquiring, retaining, and recalling verbal material) and delayed recall.

The Madison Memory Trial’s use of the above screening tests introduces major concerns about the robustness and clinical applicability of its results.

It is not common practice to use the Groton and International Shopping Recall tests in clinical practice to screen patients for memory decline.

I have never seen these tools being used in all of my time in practice.

From a real-world, clinically relevant standpoint, more well-known and proven screening tests such as the Trail Making Test Part A and B and Montreal Cognitive Assessment (MoCA) are used instead in medical practices across the country.

The Madison Memory Trial’s methods of measuring sleep and quality of life were even more troubling.

The assessments contained very serious errors.

Firstly, this part of the assessment contained very few participants.

As such, the study authors inappropriately applied the results of this analysis to the larger population (basically saying their results represented what would happen if the rest of the country took Prevagen – BIG overreach!).

Secondly, there was also a high degree of possible investigator bias.

This is because the study was of an open-label design (In which both the health providers and the patients know the drug or treatment is given).

This type of study design is inherently ripe for investigator bias, which may skew the results based on the investigators’ personal bias or feelings about the study.

Finally, there was no standardization of the assessment questions. As we can imagine, the answers from the study participants could have been “all over the place,” which would then have been difficult to measure and interpret.

Do Pharmacists Recommend Prevagen?

The Pharmacy Times states that 73% of pharmacists recommend Prevagen as the #1 memory support brand.

As a clinical pharmacist, I am extremely skeptical about this claim and question this seemingly high number of endorsements by pharmacists.

It just does not make sense to me knowing what I know about the profession.

Pharmacists don’t just overwhelmingly endorse an unproven dietary supplement to this high degree.

Personally, I would never recommend this supplement to anyone. NONE of my geriatrician colleagues will do so as well.

Then…what about the Pharmacy Times’ bold statement about the high number of pharmacist recommendations?

The following will hopefully shine some light on this strong endorsement and give us some perspective – survey participants were asked to select from a predetermined list of options.

In other words, they could not write in their choices freely, but rather, were forced to choose one product over others.

So, we can see how the lack of autonomous answer picks could have skewed the results to Prevagen.

In my opinion, this supplement has earned its place in popularity due to an extensive national advertising campaign, promotional emails, and tv spots.

Sophisticated and targeted advertising efforts by the manufacturer have also helped drive sales favorably for Prevagen.

Does It Pass My “Mom” Test?

So, back to the original question: Does Prevagen Help Improve Memory or reduce cognitive decline? Would I give this supplement to my own mom? 

Absolutely Not!

I believe that Prevagen provides no real benefit whatsoever to improving memory and learning.

From an efficacy standpoint, the company-sponsored study, as analyzed above, does not prove this.

From a safety standpoint, it is a supplement, not regulated by the FDA.

More importantly, the company’s lack of transparency about reporting adverse effects is deeply troubling.

What We Need To Know About Supplements

Because dietary supplements are not drugs, they are not monitored by the FDA in the same way.

Any two tablets taken from the same bottle may not have the same proportion of ingredients.

This is the loophole that some dietary supplement manufacturers exploit. It is unclear if apoaequorin is truly safe, due to the lack of long-term science-based evidence.

As of January 31, 2023, the prices listed on Amazon are as follows:

  • $56 (Prevagen Regular Strength/60 capsules)
  • $83 (“Prevagen Extra Strength”/60 capsules)
  • $129 (“Prevagen Professional Strength”/30 capsules, 2-pack)

If we translate this to annual costs, the dollar amount comes to $336 – $774.

To many Americans, this is a lot of money that they don’t have.

Additionally, I have seen that the manufacturer keeps increasing the price over time.

In my opinion, that money would be better used to pay for prescription medications, healthcare, food, and other vital daily expenses.

Final Points

  • Does Prevagen Help Improve Memory? No!
  • Prevagen has a questionable track record and pushes false and misleading claims
  • The maker of Prevagen left out severe adverse events in its reporting to the FDA
  • The apoaequorin used in your prevagen has no relationship to memory or brain function
  • It is EXPENSIVE!!!
  • It fails my “Mom” Test – I would never give it to my own Mother

I hope you found this article helpful! Please be on the lookout for many more fact-based and well-researched posts related to geriatric pharmacy.

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