People who use currently common supplements to help with sleep and other issues may be in for a rude awakening.
The FDA is targeting melatonin, choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP) and methylcobalamin (or methyl B12) for tighter regulation, or even possible bans.
An online meeting scheduled on June 9 of the FDA’s Pharmacy Compounding Advisory Committee, was posted with a request for comments concerning the supplements.
It’s another disconcerting development for a government agency that has shown a repeated willingness to steer money to mega pharmaceutical companies, at the expense of the health and well-being of average Americans.
The FDA is under fire for suppressing cheap medicines including Ivermectin and hydroxychloroquine, which a number of doctors and studies have advocated as beneficial in mitigating the severity of COVID-19 infections (for more info, see our 11 May 2021 Trends Journal article “WHY HYDROXYCHLOROQUINE & IVERMECTIN ARE BEING OFFICIALLY SUPPRESSED”).
They also recently disparaged supplements including NAC (N Acetyl Cysteine) and Quercetin, both of which are utilized by many people who claim benefits in reducing congestion and clearing toxins, etc.
Melatonin, meanwhile, is currently one of the most common ingredients in non-prescription sleep aids, used by millions of Americans.
People with conditions including MTHFR have reported beneficial results from taking supplements on the FDA’s target list. Though still not fully understood, MTHFR includes a range of genetic mutations which affect the ability to utilize folate, a common B vitamin. MTHFR can be associated with elevated homocysteine levels. Folate is involved in many metabolic processes including synthesis of norepinephrine, serotonin, and dopamine. All of those affect the brain’s relative wakefulness and sleep states.
The FDA review garnered nearly two-thousand comments, most of which implored the agency not to attempt to remove the supplements from the public. A few example comments included:
“Getting rid of these supplements is ridiculous. We have millions of people subjecting themselves to an experimental vaccine that has been around for a fraction of the time people have been trusting these supplements and using them to support their bodies.”
Jen Miller 05-25-2021
“Please do not remove access to B-12 shots made with Methylcobalamin!! My son is autistic, doesn’t detox and is missing both his glutathione genes. His inadequate methylation cycle is strengthened through the administration of B-12 shots!! For me I have inherited both Dementia genes from my parents. My mother passed away in June 2019 from Dementia. B-12 shots with Methylcobalamin are also a known treatment to delay the onset and remediate the symptoms of dementia but are lesser known because they aren’t considered by the drug companies as a recognized treatment. The shots as well as good health habits when you’re yet to exhibit symptoms are a pre-emptive strike against a disease that as I have experienced with my mother can be worse than death itself. Thanks for your consideration,”
Margaret and Mitchell Wilson, 05-25-2021
More comments regarding the FDA’s possible regulation can be found here.