The Food and Drug Administration (FDA) is currently evaluating the status of various supplements including Magnesium, Creatine, and Aloe Vera in bulk supplements after their focus on NAC (N-Acetyl L-Cysteine) led to Amazon completely pulling the anti-oxidant precursor used to protect Tylenol overdose patient’s livers.

Several supplement vendors have begun selling products in bulk to address certain demands — like testosterone boosters and immune system boosters — raising potential fears over their safety.

Many of the supplements on the list included common household names. NAC, on the other hand, has been legally obtainable for decades over-the-counter but the supplement has recently been subject to increased scrutiny in recent months — especially as some believed the supplement to protect the body against Covid-19.

SARMs distributors have also received increased pressure from the FDA. Major SARMs provider Proven Peptides shut down their enterprise after a letter from the FDA. Our provider, Rats Army, has also experienced pressure from the FDA.

A List of Supplements In The FDA’s Crosshairs

The list below is taken from a publicly-available document on the FDA’s website.

On the website, the FDA says the following about the devised list:

This guidance sets forth the Food and Drug Administration’s (FDA or Agency) interim regulatory
policy concerning compounding using bulk drug substances under section 503A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act or Act). Section 503A of the FD&C Act includes certain
restrictions on the bulk drug substances that can be used in compounding and directs FDA to develop
a list of bulk drug substances that can be used in compounding under that section.

FDA is developing this list of bulk drug substances (the 503A bulks list), and this guidance describes
FDA’s interim regulatory policy for licensed pharmacists in State-licensed pharmacies and Federal
facilities and for licensed physicians that compound human drug products using bulk drug substances
while the list is being developed.

The lengthy list continued:

Image

The Reception of This News

FDA NAC
FDA takes aim at NAC and other supplements

Health conscious individuals on social media didn’t take too kindly to the revelation that the administration was reevaluating supplements considered safe and enjoyed by consumers for decades.

One person tweeted a lengthy thread venting her frustrations at the list.

“The FDA has lost their f***ing minds, Related thread below from @Tweetweetbeyoch Full list of herbs & Supplements up for hearing on stricter regulations including parsley, anise, molasses…” they tweeted.

https://twitter.com/VeritasTXgem/status/1395920671763574784
The outraged tweets

Another tweeter added: “PLEASE PAY ATTENTION. Many of the supplements/vitamins/amino acids they are banning are essential for the health of those dealing with autoimmune and chronic illness.”

“FDA Wants to remove a Medical Necessity for Many Health Conditions – Choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin (also known as methyl-B12),” they continued.

https://twitter.com/sallyKP/status/1396162734732070913

Further down in the thread, the tweeter discusses how “The FDA has announced a public meeting of the Pharmacy Compounding Advisory Committee on Wednesday, June 9 2021 to discuss docket number: FDA-2021-N-0357.”

She adds: “Agenda: The committee will discuss 4 drug substances nominated for inclusion on the “503A Bulks List” potentially banning the following drugs to be provided by compounding pharmacies to patients: Choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin.

“and methylcobalamin (also known as methyl-B12) Ample research and numerous testimonials support the use of these drugs for supplementation of patients with cases of vitamin B12 deficiencies, sleep disorders, neurotransmitter imbalances and blood cell formation, to name a few.”

https://twitter.com/sallyKP/status/1396162740536946692

However, some believed that the move to take a closer look at the listed supplements were for when they are consumed in bulk in conjunction with other supplements. NAC garnered attention over its marketability as a “hangover cure” for its liver protecting properties.

“The list is being misinterpreted – only list 2 is being not reccomended [sic], list 1 is being evaluated to be added and list 3 was submitted for [evaluation] but FDA wants more info to substantiate the need/value — roughly,” remarked a dietician on Twitter.

Don’t hesitate to email us at [email protected] for personalized coaching and a client questionnaire if you’d like DEDICATED tailor-made personal training on strength training, building muscle, losing fat, developing athleticism, and more — all to your liking, lifestyle, habits, and taste!

Otherwise, don’t forget to claim your FREE eBook detailing how to lose 20lb of fat while building muscle in 12 weeks! You can claim it here.

Alternatively, you can pick up a FREE eBook on fundamental strength principles offering an introductory workout program.