Does the Bacopa Monnieri sold by Peak Nootropics, LLC (also known as Advanced Nootropics) help prevent Alzheimer’s disease? Does the L-Dopa it sells help control involuntary movement in Parkinson’s disease patients?
Did you buy supplements from this company, believing the drug-like claims for them? If so, we’d like to hear from you.
If a supplement is marketed as preventing, treating, or curing a disease, it is considered a drug. Before a drug can be sold in interstate commerce, it must be approved by the Food and Drug Administration (FDA). This is a long process involving rigorous testing and clinical trials to make sure that the drug is both safe and effective.
The FDA has sent a Warning Letter to Peak Nootropics about the drug-like claims it makes for these supplements on its website:
- Bacopa Monnieri
- Rhodiola Rosea
The letter quotes some of the drug-like claims, including these:
- For Bacopa Monnieri: “…use to…stave off illnesses such as Alzheimer’s” and “…helps in protecting infants against neonatal hypoglycemia also known as low sugar[.]”
- For L-Dopa: “L-Dopa is often recommended for Parkinson’s patients, as it helps in controlling involuntary movement generated in the skeletal muscles.”
- For L-Theanine: “…it could be a vital component in the treatment of Alzheimer’s disease” and “…it could be an aid in combating schizophrenia or schizoaffective disorder.”
- For Phenylpiracetam: “Phenylpiracetam may be an alternative for those with ADHD not wanting to resort to typical ADHD medications.”
- For Rhodiola Rosea: “Rhodiola supplements are supposed to help in the reduction of cancer cells.”
The company uses many hedging words, like “could be,” “may,” and “are supposed to,” but this doesn’t make a difference to the FDA. It seems that if consumers are led to consider the substance for use against a disease, it is a drug.
A second issue in the Warning Letter is the requirement that drugs be labeled with adequate instructions for use. Some of the items listed in the letter, the FDA says, “are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes.” In other words, these supplements should be available only by prescription, ensuring that a doctor is supervising their use.
The Warning Letter allows the company fifteen business days to change the statements on its website.
It’s good that the FDA is alert to large promises about supplements that have not been stringently tested. But what about all the people who have already believed the drug-like claims?
If you bought any of the products listed, we’d like to know whether you were influenced by the drug-like claims the company made for them. Fill out the form on this page and let us know about your experience.Article Type: Investigation