Pharma Piracy Threatens Brain Health Supplement

January 9, 2020

The FDA is complicit in turning another supplement into an expensive drug. Action Alert!

Earlier this year, the FDA fired off warning letters to seventeen companies that, in the agency’s view, were illegally marketing supplements to treat Alzheimer’s disease. One of the supplements targeted in the FDA’s action was piracetam, a derivative of GABA, continuing an FDA trend of attacking brain health supplements to protect drug industry profits.

Piracetam has been on the market as a supplement for years. It is approved as a drug in Europe and prescribed for cognitive impairment and dementia. Researchers think that piracetam helps the brain by boosting energy production in brain cells. As we age, our brain cells decline in their ability to generate energy; this decline in energy causes cellular “debris” to accumulate which can kill brain cells and eventually lead to senility.

The FDA’s treatment of piracetam highlights how broken our system is. This relates to the “new supplement” notification process we’ve discussed many times. Any supplement that came to the market after 1994 is considered a “new supplement.” Companies that want to sell new supplements must notify the FDA 75 days in advance of marketing the product. In implementing this provision of the law, though, the FDA has been trying to turn this notification process into a de facto pre-approval process. The agency has also adopted an expansive view of what constitutes a new supplement.

Additionally, if a compound is being investigated for use in a drug, and that process started before a “new supplement” notification was filed on that compound, then that substance cannot be sold as a supplement—even if the drug company abandons the research on that compound. This, remember, is what happened with pyridoxamine, a crucial form of vitamin B6. Additionally, L-glutamine and CBD have both been turned into drugs through this mechanism.

Which brings us back to piracetam. In 2004, the FDA rejected a new supplement notification for piracetam, saying the submission was incomplete. This is understandable, given that requirements for complying with new supplement notification rules have not been completed by the FDA. The agency published its first draft guidance for new supplement notifications in 2011, almost 20 years after the law was passed. This draft was withdrawn after ANH-USA and other stakeholders pointed out glaring problems in the guidance, and a revised draft wasn’t released until 2016—and still has not been completed. For all this time, companies have been in the dark about how to comply with the FDA’s new supplement policies—but the drug industry can still start researching these compounds to corner the market and prevent supplement versions from being legally marketed.

This is likely what will happen with piracetam. In a 2012 warning letter, the FDA stated that piracetam was being investigated as a new drug, and since there is no evidence that it was marketed as a supplement before that, it cannot be a supplement.

To summarize, then, supplement companies have tried to file a new supplement notification on piracetam—but the FDA has not completed its policies explaining how to file these notifications. The piracetam notification was rejected, and in the meantime a drug company has started investigating piracetam as a drug, meaning that it can’t be sold as a supplement. Clearly the deck is stacked against the natural products industry.

The FDA has also moved against vinpocetine and picamilon, two other brain health supplements. At the same time, major trials for Alzheimer’s drugs keep failingand failing. Is the FDA clearing the way for Big Pharma to turn these natural compounds into expensive drugs? Given the agency’s recent history, this seems the most likely explanation.

Action Alert! Tell the FDA and Congress to protect access to piracetam and other brain health supplements. Please send your message immediately.

 

29 responses to “Pharma Piracy Threatens Brain Health Supplement”

  1. Kris Marohn says:

    Stop stealing natural substances to turn them into drugs.

  2. Peter Booth Lee says:

    Back Off!

  3. Heather Haverfield says:

    This is a shameful preference for Big Pharma over Health supplements. I have witnessed so many people taking pharmaceuticals suffer from side effects which then lead to another drug to handle the problem over & over until they are taking multiple drugs. Then their overall health continues to decline. Let people make their own choices which can be safer & cheaper with supplements.

  4. Terri Allore says:

    This is simply outrageous to allow the FDA to patent this natural health supplement for Dementia that was sold in health food stores. No wonder people die because they can’t afford the FDA “Drugs”! Who is overseeing the FDA? Obviously, they can do whatever they want to rip people off!

  5. Karin Barger says:

    Leave our supplement choices alone. I believe that to take a supplement or not is clearly my decision, and as a supplement, I expect it’s availability on a store shelf. Pharmaceutical industries do not have the right to claim these supplements as their products, nor to deny my right to purchase them as supplements, and not have to pay outrageous prices they would like to assign to them.

  6. V says:

    FDA keep your hands off our supplements. We know you are in the pockets of big Pharma. We are sick of the corruption you represent.

  7. jerry vinal says:

    IF THE GOVT CANNOT TAKE CARE OF THE PEOPLE THEN WE WILL JUST IGNORE THEM AND DO WHAT WE WISH.ANY MONKEY CAN SEE THAT THE FDA DOES NOT PROTECT PEOPLE WHEN INDIVIDUALS ON THE BOARD YOYO BACK AND FORTH WITH THE DRUG INDUSTRY!!!!!!!!!!!!!!!

  8. PE EP says:

    Stop This

  9. Christopher Calkins says:

    Our FDA is a criminal organization, just like all of the other Rockifeller captured Alphabet Agencies. These organizations are supposed to look out for us and our environment instead of looking out for the companies they are supposed to monitor. Wow, how upside down. We now live in a world where truth is a lie and la lie is truth. Seek the Truth and Speak the Truth!

  10. Toni says:

    It is quite evident that FDA loyalties lie with pharmaceutical companies, not with the citizens that it supposedly “protects.” However, no where is that more glaringly obvious than in the arena of brain health supplements. Even though thousands of people are battling dementia, FDA is much more concerned with protecting Big Pharma profits than allowing natural health companies to provide relief to these poor patients and their families. After al, what’s more important? Pharma’s bottom line, that’s what. We need Congressional intervention! Please don’t allow the FDA to create regulations that they do not have to clarify, but they can still somehow hold natural companies accountable for not keeping clarifications that haven’t been provided. It’s ludicrous!! Unfortunately, money talks big in government circles.
    Come on, Congress, stop the money trail & enable citizens to help themselves!!

  11. M Jenkins says:

    It is vital that he FDA and Congress protect citizens longstanding access to piracetam and other brain health supplements. It should not be the case that this can be obstructed because a drug company starts investigating any such supplement as a drug.

  12. michael souidant says:

    Producers of supplements should not have their sales restricted or forbidden just because a pharmaceutical corporation develops an interest in a given supplement. If a pharmaceutical company wants to market an identical or similar product then let them compete for the dollars citizens are willing to spend on such products. At the least supplement companes should have a clearly stated set f rules which govern these transactions.

  13. Pierre Messier says:

    We from Canada would like to help, but your automated system sending letter to member of Congress, Senator and FDA request a valid US Zip Code that we indeed do not have, and thus refuses our letter. I suggest that you modified your said automated System to bypass House and Senate and send to FDA only upon recognizing a foreign adress/country other then the USA.

  14. Mary Kay Beattie says:

    Protect access to piracetam and other brain health supplements.

  15. Darlene says:

    Greedy Pharma wants to make natural alternative substances illegal if they cannot patent the active ingredients, even though poor health and many subsequent prescriptions for drug induced illnesses, are guaranteed to follow.

    Back off Pharma!

  16. mattie says:

    Recently came across an Ayrvedic herb that astounded me by its rapid effectiveness. Contracting Lyme dis-ease began the barrage of many severe & bewildering symptoms. When it attacked my brain, I knew I had to find a solution. Tried the Western herbs. While they caused no evident harm, they also didn’t help. Tried 2 Indian herbs. The one worked so well, I’m still in awe. It wasn’t easy to find it because of the vast information & seemingly countless herbs, recommended. Searching for ‘brain health herbs’ also offered many encapsulated multi-herb-combos. This one herb is affordable & can be bought from Indian sellers on ebay. I want to scream about it from the rooftops. I want to share my success with everyone else who’s suffering from Lyme brain and other brain issues. It’s a big fear that ‘they’ will try to steal this miracle plant from us, also. I’m afraid to share its name online! How can I tell others about it without alerting these vultures of its virtues?

  17. Laura Bower says:

    With so many cases of the Alzheimers, why would the FDA want to keep these supplements from the public if they in fact got some help with this devastating disease that not only destroys the life of the individual with the disease but all those around their loved one or friend. What a sad society that is only concerned about the dollar bill and not the health of the individual. There are many people that live in this country that do not rely on the drug companies for their health and wish to pursue other avenues, natural avenues and that should be our right in a free country. I am asking the FDA and Congress to protect the access to Piracetam and other brain supplements

  18. Sandra Triantafillos says:

    FDA and Congress: It is not your place to determine what supplement is to be taken off of the market to be replaced by some pharmaceutical drug that we will be charged for, that mimics the supplement. How dare you mess with our natural health supplements. It is not enough that you have your hands into vaccines and other pharmaceuticals. You all need to be FIRED. Remember…this government is For The People By The People. The SWAMP is deeper than anyone could imagine. YOU ALL HAVE BLOOD ON YOUR HANDS!!! All the felons involved in the pharmaceutical industry need to be exposed!!! MAY GOD HAVE MERCY ON ALL OF YOUR SOULS! Thousands die every year due to the pharmaceuticals that doctors have put their patients on. Most of these drugs should of never been approved in the first place. When is this insanity going to stop!!! Do your research!!!

  19. It is super frustrating that there are natural supplements that can help people and big pharma is only concerned with making money instead of helping people!

  20. Stanley Foodim says:

    Allow pyridoxamine and other supplements to function as they have for many years without turning them into expensive drugs.

  21. Sallie Robbins-Druian says:

    ANOTHER ABUSIVE ACTION ON THE AMERICAN TAXPAYER & PEOPLE! LEAVE THE SUPPLEMENTS ALONE! THIS IS A MISREPRESENTATION OF A SUPPLEMENT IN A MANUFACTURED DRUG LIE! YOU HAVE TO BE BLIND, DEAF & DUMB TO SEE THIS IS ONLY ABOUT MONEY FOR BIG PHARMA! NICE TRY. JIGGING UP A SUPPLEMENT TO THE RANK OF A PRESCRIPTION DRUG, IS AN ATROCITY! WE KNOW WHO YOU ARE AND WE DEMAND THAT THE FDA AND CONGRESS PROTECT ACCESS TO PIRACETAM AND OTHER BRAIN HEALTH SUPPLEMENTS – PLUS OTHER OBVIOUS POTENTIAL DRUGS FROM NATURAL BASED SUPPLEMENTS IS FRAUD!

  22. Tamara Owen says:

    Please allow supplements such as Piracetam, Vinpocetine and Picamilon to be sold to the public. If a supplement can aid in cognition and diminishing dementia this is a good thing. Isn’t it better to have people who can think better and take care of themselves longer? This can put less burden on the health care system.

  23. Robin Patten says:

    Please do not let big pharma co-opt supplements.

  24. Linda Chamberlin says:

    If pharmaceuticals were so great, they wouldn’t be worried about natural medicine. They are worried, however, because natural medicine is always so much better. Always. That’s why Big Pharma is so desperate to eliminate any competition — and their only competition is Nature. Wouldn’t want their karma!!!

  25. Jan Thomas says:

    More corporate abuse with government collusion. Will no one save us from this troublesome president?

  26. The FDA has not done enough to stop drugs that kill or have disastrous side effects, but they want to prevent natural supplements from helping people. If the drugs they have approved cause a lot of side effects, they will have another drug to”help”. They don’t want the public to find anything natural for what they are battling. It’s all about the money. These supplement companies that have found these natural helps should have an honest level of compensation for all they have done before the FDA has stolen it from them as a “drug”. If they won’t compensate, then they should have to turn it loose to those natural companies.

  27. CAROL says:

    Please protect access to piracetam and other brain health supplements.

  28. Kris Olson says:

    Our beloved government complains about the high cost of health care. This is one big reason that
    health costs are so high. The pirates of Big Pharma take simple things like Insulin, around since the 1920’s and charge $300+ for a couple of ounces! This is another attempt to hijack a natural product that works so they can charge 100x the current price! It’s time to stop the Drug Companies from their evil work… The FDA is their puppet and is becoming less relevant every year..

  29. Alice says:

    I believe in freedom of choice. Banning the availability of supplements is not a good idea. Forcing an increase in price is not a good idea. With people living longer it is necessary to keep functioning in a healthy manner. Thank you ANH for reporting on this.

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