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FDA Cracking Down on Dietary Supplements for Dementia

Some companies promoting products to treat Alzheimer's disease have received warning letters from the FDA: Don't sell dietary supplements for dementia!
Health vitamin and dietary supplement as an alternative medicine and naturopathy or homeopathy symbol as a finger holding a gree pill with 3D illustration elements.

The Food and Drug Administration has just taken action against many companies that advertise their dietary supplements for dementia. The commercials often imply that these products could be used to treat Alzheimer’s disease. The FDA has sent warning letters advising these firms that their supplements are considered unapproved or misbranded drugs.

These products have not been approved by the agency and they have not been proven safe and effective. If the companies do not correct their violations within two weeks, the FDA has threatened to take legal action. The agency could seize the dietary supplements or charge fines. In the meantime, the FDA encourages consumers to remain vigilant so as to “avoid purchasing products that claim to prevent, treat or cure diseases without any proof they will work.”

Dietary Supplements for Dementia Are Not the Only Problems:

This crackdown is part of a larger initiative. FDA Commissioner Scott Gottlieb announced that the agency is planning to modernize its dietary supplement regulation. The agency has not changed its approach to dietary supplements for dementia or any other serious problem since 1994. That is when Congress passed the Dietary Supplement and Health Education Act, known as DSHEA. However, the business of dietary supplements has changed enormously in the past 25 years.

Commissioner Gottlieb pointed out that

“What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.”

The FDA says it wants to make sure that consumers continue to have access to safe supplements. Consequently, the agency plans to communicate more promptly and clearly about problems. In addition, the FDA wishes to evaluate product safety while still promoting innovation. It acknowledges that this will require new enforcement strategies and public dialogue. In this way, the agency hopes to protect the public from adulterated and misbranded products, starting with dietary supplements for dementia that have no known impact on cognitive function. 

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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For everyone that wants to know what supplements that the FDA is talking about you can do you own internet search to find out what companies the FDA sent letters to. Search terms are something like this: FDA crack down on supplements for dementia.

Time after time we see that lack of oversight never benefits consumers. This is especially problematic with drugs of any stripe being brought into this country.

Looks to me like the FDA is up to its old tricks of downgrading supplements so it can push overhyped and overpriced prescription drugs for Big Pharma and its stockholders. I don’t trust what the FDA says any more. I go to a disillusioned MD who prescribes mostly supplements and vitamins on the basis of my lab tests — with good results and no side effects.

List the supplements!

Do not trust the FDA! Just too many things ‘approved’ that have later been proven detrimental.
Then this. Curtailing my freedom of choice.

My caveat is: when in need then anything that may help but definitely will not hurt/damage is worth a try and my choice. And yes, definitely research first. Right here and from other reputable sources. The damage I have suffered from prescription meds is too long a list. Yes, lists would be helpful.

This makes my blood boil. Thank you for reminding me of the dangers of the FDA.

I doubt the reliability of information coming from the FDA under the direction of Gottlieb who has been a leader in the big pharma industry . We need FDA leaders who are open to whatever science discovers.

and coconut oil, mct oil are not supplements

The government/FDA is stepping in because the supplement business has grown to the point that it’s affecting Big Pharma’s profits. If they were really concerned about the health and safety of consumers, half of the “legitimate” drugs we see advertised ad nauseum on TV would be banned. A natural supplement would quickly be criminalized if it had the laundry list of side affects of most of those TV drugs.

Supplements can be just as dangerous as drugs. Different supplements can cause kidney, liver, heart, and even death so supplements should also be regulated. Some people think that since it isn’t prescribed by a doctor that it is always safe to take supplements which is of course not true.

I agree that the supplement makers should not make medical claims for the products. However, FDA is opportunistic. They look for possible openings to interfere and shut down supplement makers.

Caveat emptor is a warning, I guess, but it’s effectively worthless. Most of us already knew that much. We need names of offending companies or supplements if it’s to be of any use.

Why wouldn’t you list the names of the supplements being sold that are dangerous. This would inform the public.

The Food and Drug Administration has just taken action against many companies that advertise their dietary supplements for dementia.

I would love to see that list of companies.

It is too bad they are not as vigilant about prescription drugs. I have NEVER had a problem with dietary supplements but I have had MANY problems with prescription drugs including a coma while in the hospital and two trips to the emergency room. My husband has had two of his blood pressure prescriptions RECALLED the latest one was losartan. Maybe they should allow the supplement people to run ads like the prescription companies do – you know with the long list of known side-effects that they say at the very end of the commercial as fast as possible so you can’t understand them – oh that’s right there are no known side effects to MOST of the supplements – MY BAD!!!!!

Seems like they both need better regulations. The warnings for some pharmacueticals leave you wondering if the benefits are worth the risk, while the supplementary world is virtually unregulated with little accountability as to what is even in the capsules, not to mention that some herbs can cause liver damage or complete failure with no warnings labeled. It’s almost like the counterfitters who supply inferior manufactured parts for the essential equipment which we rely on for safety in our daily lives. Too much money to be made to be bothered by legalities.

Thanks for the dementia / supplement info. Could you please list the products being targeted by the FDA? We’re specifically interested in the status and reputation of Prevagen.

Thanks for your help. We love the info you provide – always interesting and often of use to us personally.

B.V. Cooper

The FTC and the NY Attorney General tried to sue saying that the maker of Prevagen made false and unsubstantiated claim put the court dismisses the lawsuit.

If only they were as vigilant about the drugs that are approved with many detrimental side effects. Supplements may help with dementia and are less likely to be detrimental. It’s like the FDA wants us to get dementia so we will take the drugs they approve but only make our life worse, adding even more drugs. We have to be our own advocate for how our health is treated.

It’s unfortunate that the vulnerable are once again being targeted and all in the name of money.

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