Prevagen: The Poster Child For Media Failure On Quackery

"New York Attorney General Letitia James today announced that a federal judge in Manhattan accepted a jury’s finding that Quincy Bioscience Holding Company, Inc., Quincy Bioscience, LLC, Prevagen, Inc., Quincy Bioscience Manufacturing, LLC (Quincy), and four corporate defendants made fraudulent and deceptive statements about the supplement Prevagen and are liable for violating New York’s consumer protection laws. Quincy advertised its supplement, Prevagen, in media markets across New York, including in Albany, Syracuse, New York City, and the Southern Tier, as a way to reduce memory problems, improve memory, and support cognitive health. After a two-week trial, the jury concluded that Quincy had not substantiated any of its claims about Prevagen with reliable scientific evidence." (link)

Why are supplements legally advertised? There must be more than the FDA's warning, you can hardly read it because it's so small.

Nootropics Supplements: Typical Quackery

"Chris Kresser is a licensed acupuncturist and self-identified proponent and practitioner of functional medicine and ancestral health. He has his own website with lots of health information, articles, and links to various businesses, many his own. It’s important to know that he doesn’t have any formal training in medicine or research.

"ACSH recently published an explainer piece on nootropics briefly touching on the idea that prominent wellness influencers often have their own lines of supplements that may include nootropics. Kresser is a prime example. In a 2024 article about nootropics on his website, Kresser discusses his favorite caffeine-free nootropics to help you “enhance your brainpower, sharpen your focus, and protect your cognitive health as you age.” They include citicoline, lion’s mane mushroom, phosphatidylserine, Bacopa monnieri, ginkgo biloba, uridine monophosphate, and alpinia galanga. Let’s go through these one by one."

Click here for the rest of the article.

Hidden Dangers Of Vitamins And Supplements

"In 2016, FRONTLINE, The New York Times, and the Canadian Broadcasting Corporation examined the hidden dangers of vitamins and supplements, a multibillion-dollar industry with limited FDA oversight. 

"When 'Supplements and Safety' aired, it was estimated that half of all Americans took a health supplement daily, from fish oil to multivitamins to diet pills. However, the acting commissioner of the Food and Drug Administration at the time noted in 'Supplements and Safety' that, 'The FDA does not review dietary supplements before they come onto the market, and I think that all consumers need to understand this.”

Click on the link below for the classic 53-minute video that is as relevant today as it was 8 years ago. The only changes that I can see are that some recent studies do support a daily multivitamin if there is a question of quality of diet (link) and the Omega 3 in fish oil has been found to lower blood pressure and perhaps has a positive effect on heart health (link).

Supplements and Safety (full documentary)

Supplements: Not Only Mostly Useless, They Can Be Dangerous

"The Food and Drug Administration (FDA) originated from the passage of the 1906 Pure Food and Drugs act aimed to rein in the long-standing abuse in the consumer product marketplace. The act was passed to prohibit interstate commerce of misbranded and adulterated foods, drinks, drugs. Thus, promoting the FDA’s mission to protect the public health by regulating human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and tobacco to ensure safety, efficacy, and security. Progressing further in 1994, the Dietary Supplement Health and Education Act (DSHEA) was established designating specific label requirements, providing regulatory framework, and authorizing the FDA to promulgate good manufacturing practices for dietary supplements. This act defined and classified “dietary supplements” and “dietary ingredients” as food requiring all over the counter products (OTC) products to consist of labeling that is easy to understand and meets the FDA quality, effectiveness, and * safety standards. However, under the umbrella of OTC products, the FDA fell short in its regulation of the expansive dietary supplement market. The objective of this study is to discern how the lack of efficacy in the FDA's regulations of OTC dietary supplements inevitably inspired more harm than benefit."

Click on the link below for the details of a professional review of dietary supplements and their harm:

The FDA’s * Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Events

* Effectiveness: the FDA does NOT certify the effectiveness of dietary supplements, only safety

* Perfunctory: superficial; lack of interest (Merriam-Webster Dictionary)

The Truth About Supplements

"Though many supplements are certainly beneficial to your health, evidence varies widely, and it’s important to know which can benefit your health and which may be harmful."

Click on the links below for the details:

5 Things You Need to Know About Dietary Supplements

What's really in that sports supplement?

Bottom line: do NOT take supplements without your primary care provider's supervision and after appropriate blood tests for vitamin and mineral deficiencies:

Vitamin Deficiencies And Nutrition Levels From Blood Testing

Oh, if the product is marketed as a "supplement", you can count on it NOT being tested medicine. Please look for the FDA disclaimer, such as:

On the positive side, Omega 3 Fatty Acids promote health and most people do not get enough.

Balance Of Nature: Not So Much

"Balance of Nature has agreed to pay $1.1 million to settle a lawsuit filed by consumer protection officials in California alleging the company falsely advertised that its supplements could prevent, treat or cure diseases including diabetes, fibromyalgia, arthritis, heart disease, and even cancer.

“The company went so far as to recommend that customers take 12 capsules each of its Fruits and Veggies supplements if they had been ‘diagnosed with life-threatening illness,’ the Santa Clara County District Attorney’s Office said Wednesday in a press release announcing the settlement. 'Balance of Nature also used customer testimonials to make false claims.'"

Click on the link below for more information about this supplement (not medicine) that is all over TV news shows:

Lawsuit alleged company falsely advertised that its Fruits and Veggies supplements could prevent, treat or cure serious diseases.

Balance Of Nature: Let The Buyer Beware

One cannot avoid scams if in any way exposed to media. The following is a particularly egregious example of such from the world of unregulated supplements:

"Balance of Nature, Inc. represents that its dietary supplement provides the nutrition of over 10 servings of whole fruits and vegetables per day, enhances the immune system, and has numerous other health benefits. They rely almost exclusively on testimonials.

"Balance of Nature does not explicitly claim to cure or treat any disease. Instead they use testimonials from people making claims - which are highly subjective and cannot be substantiated - like "Since taking Balance of Nature, I have more energy." Guess what? If you ate a cup of sugar every day, you'd "have more energy", but does that mean that it is a good thing to do?"

Click on the link below for more:

Product Misleading Advertising: Balance of Nature

Harriet Hall: The "SkepDoc" Continues To Debunk Nonsense

For most of my professional life as a physical therapist, there was no one who gave me more fuel to combat medical quackery than my contemporary-in-age Harriet Hall, MD: "a U.S. retired family physician, former U.S. Air Force flight surgeon and skeptic who writes about alternative medicine and quackery for Skeptic and Skeptical Inquirer. She writes under the name The SkepDoc."

Click on the links below for recent examples from her biting commentary that I regularly receive via email (she is no longer accepting requests for such, but, if you would like to get on a "Forward" list that I am creating, send me your email), She also is on Facebook:

Neuroplastic Nonsense

Bobath Cerebral Palsy and Stroke Rehab Nonsense

Supplements: Misguided Marketing

Race and Medicine

Medicine For The Brain

If you are exposed to any media, you are deluged with alternatives to medicine pseudoscience, including brain health supplements such as Prevagen. Regarding the brain, the best things you can do for its health are simple and inexpensive. Neurosurgeon Sanjay Gupta, MD, has some advice in a new book, "Keep Sharp." The book is supported by the fact that we now know that the brain is able to grow new cells throughout life. The big revelation to me was the following:

• "I think that crossword puzzles and brain training exercises can be quite helpful at making the roads in your brain that you use a lot already, keeping them strong. ... It's kind of the "practice makes perfect" part of your brain. And some of the brain games can actually increase your processing speed, the speed at which you process new content and new information. But I really do draw a line between that and keeping a brain sharper and building cognitive reserve throughout your life. That's different. You want to be doing different things in order to build that reserve, as opposed to doing the same thing better and better. There's a role for both, but if it's cognitive reserve you're looking for, doing different things — things that *get you outside your comfort zone* — it's probably going to have a much bigger payoff."

Click here for an NPR interview with Dr. Gupta.

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*to include learning why others have different opinions than you?*

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UPDATE: 2/24/2021

Below are more links on this topic:

Brain Boosting Supplements May Contain Unapproved Drugs

Focus Factor Fiction?

FDA curbs unfounded memory supplement claims

Beware Of Media Promotion Of Prevagen

"From the memory supplement’s launch in 2007 through 2016, agency officials repeatedly raised concerns as the number of consumer complaints grew."

"Though drugs and dietary supplements are both regulated by the FDA under the Federal Food Drug & Cosmetic Act, they’re held to vastly different standards. The FDA requires drug manufacturers to prove through rigorous testing that their products are safe and effective before they are approved to enter the market. The agency lacks the same authority when it comes to supplements. Instead, the companies are responsible for ensuring their products are safe and lawful, and in many cases, they can introduce new dietary supplements to the market without even notifying the agency. As a result, supplements are generally presumed safe until proven otherwise."

Prevagen is just a canary in the coal mine of supplements

Do You Take Probiotics?

With ALL dietary supplements, do your research on them before you start taking them. Most do not have FDA approval regarding effectiveness.

Do Probiotics Actually Do Anything?

Dietary Supplements: Let The Buyer Beware

"Most people think that dietary supplements and herbs are closely regulated to ensure that they are safe, effective, and truthfully advertised. Nothing could be further from the truth. Although some aspects of marketing are regulated, the United States Congress has concluded that “informed” consumers need little government protection. This conclusion was embodied in the Dietary Supplement Health and Education Act of 1994—commonly referred to as “DSHEA”—which severely limits the FDA’s ability to regulate these products."

Click on link below:

Don't Depend on the FDA to help you

Brain Health And Other Supplements

"Many people across the globe are interested in learning that it is possible to influence their own brain health and in finding out what can be done to maintain their brain health as they age. We aim to be a trustworthy source of information, basing recommendations on current evidence supplemented by a consensus of experts from a broad array of disciplines and perspectives." (link)

Supplements Not Helpful With Cardio-Vascular Disease

Recent research does not support supplements for CVD:

Another Nail in the Coffin for Fish Oil Supplements

Supplemental Vitamins and Minerals for CVD Prevention and Treatment Not Supported

Dietary Supplements Are Not Medicine

Contrary to the ubiquitous advertising of these products, dietary supplements are NOT medicine. They have not gone through the rigorous testing for safety and effectiveness that drugs and medical products have to go through. Look carefully at the label on all dietary supplements in pharmacies and on media advertisements. If you see the following required label, it is not a medical product:














Generally, if one is healthy, one does not need dietary supplementation.  However, if you do have a medical problem that may benefit from them, your physician may recommend that you take them. Click here for a list of dietary supplements.

Probiotics: Beware Of The Hype

Probiotics are the topic of many informercials. However, if you are healthy, do you need them?

"Although certain bacteria help treat some gut disorders, they have no known benefits for healthy people"

Do Probiotics Really Work?

Proper Food Will Always Trump Supplements For Health

We are inundated with advertizements for all sorts of supplements to maintain and improve health.  The truth? "Food is always a better source of nutrients than a pill"

Heads up: when any supplement is advertised, this warning is always included:

• Unlike drugs, supplements are not permitted to be marketed for the purpose of treating, diagnosing, preventing, or curing diseases. That means supplements should not make disease claims, such as “lowers high cholesterol” or “treats heart disease.” Claims like these cannot be legitimately made for dietary supplements.  (link)

A Change In The Types Of Supplements Used By The Public

"Dr. Kantor and colleagues suggest that much of the changes in supplement use reflected media reports of the efficacy of the various items in addressing the risk of various chronic ailments — they noted several expert bodies concluded that 'there is either insufficient or no evidence to support uses of MVMM [multivitamin multimineral supplements] or supplements to prevent chronic disease". (See here for our take on those conclusions)."

Americans Catching on that Dietary Supplements are More Fad than Fact

Autism And Alternatives To Medicine

"Naturopaths, to put it bluntly, are fake doctors. They are fake because they do not have a professional standard of care that is evidence-based and transparent. They have no standard of care – literally anything goes. What they have is a very loose philosophy with a vague appeal to nature fallacy. That’s it. They use an eclectic combination of disproven, fanciful, and outright pseudoscientific interventions. They may also give some basic nutrition advice, but even there they cannot be trusted because they have no standard of evidence."

"Education is great but we clearly need better regulation. The state should not licence professions without a system in place to ensure external validity and transparency. They should not licence quacks and then let them regulate themselves."

CAM Harming Children with Autism

Use Cosmetics With Caution

"The FDA’s light-handed regulation of cosmetics bears a striking resemblance to its minimal regulation of dietary supplements, although you can’t blame the FDA for either. The fault lies with Congress and only Congress can remedy the situation."

Personal Care Products Safety Act: Facelift for FDA Regulation or Lipstick on a Pig?