The FDA recently went after picamilon, a natural combination of Vitamin B3 and a substance made in the body that crosses the blood-brain barrier known as GABA. This natural substance has been so useful as a neuroprotector in boosting brain functioning that Eli Lilly decided to use it as the basis for an Alzheimer’s drug called Solanezumab. At that point, longstanding natural supplements that contain picamilon became a threat to the $7.6 billion the drug company was expected to pull in from its Alzheimer’s drug by 2024. As the drug trials entered their final rounds, supplement firms started getting letters from the FDA about not promoting its natural alternative.
The FDA’s treatment of cannabidiol is a classic example of the agency’s modus operandi. CBDs are gaining in popularity and have been shown to be even more effective than drugs at treating issues like neurological disorders, seizures and epilepsy. In fact, they are so effective that some Big Pharma firms are looking to get them approved as medicines by the FDA.
Once it was given the status of being “investigated as a new drug,” FDA rules state CBDs could no longer be considered a dietary supplement. The FDA has embarked on a regulatory intimidation campaign in hopes of making the “problem” go away. They say that cannabidiol products cannot be sold as dietary supplements and have sent warning letters out to marketers of CBD products.
Who is the FDA really protecting?
Under this rather twisted rule, the FDA could eventually stop the sale of any herb or vitamin as a dietary supplement as long as a drug company is studying it. This is quite useful for Big Pharma, who can effectively cut out the competition before they even get their drug on the market and ensure a virtual monopoly – over something that occurs in nature, no less!
Moreover, the FDA states that even if the drug application is rescinded or does not ultimately lead to a new drug, its supplement form is still banned! This was the case with Solanezumab; while it ultimately did not deliver the expected results in the last stages of clinical trials, people will still be denied access to picamilon.
The losers in this situation, of course, are all of us. The FDA is essentially denying the American public access to effective treatments that usually cost significantly less than their pharmaceutical counterparts. It will come as little surprise to learn that when drug reviewers leave the FDA, some 57.7 percent of them go on to work or consult for the pharmaceutical industry.
According to the Alliance for Natural Health, guidance that was recently issued subjects new supplements to safety requirements that are not even placed on drugs. For example, extra safety studies are needed if a supplement’s target population changes, such as when a product that has been established as safe for adults will be marketed to children. Dangerous drugs like stimulants and antidepressants aren’t even required to do this, with the FDA admitting that most drugs prescribed for children or the elderly have not been tested on those populations.
Instead of protecting the people like it was meant to do, the FDA is protecting the drug industry that lines its pockets. People have successfully treated health ailments with unregulated herbal supplements since the times of the Ancient Chinese, but if the FDA lets Big Pharma continue to call the shots, the only way you’ll be able to get these natural healing substances is by buying them from a pharmaceutical company.
Sources include:
Please contact us for more information.
