B12 on the FDA’s Hot Seat

June 3, 2021

An FDA advisory committee could soon decide the fate of compounded B12 shots. Action Alert!

One June 9th, 2021, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) will meet to discuss whether traditional compounding pharmacies will be permitted to make medicines with methylcobalamin, choline chloride, and melatonin, among others. That compounded methylcobalamin, a bioavailable form of vitamin B12, is on the chopping block is particularly concerning, as it has shown promise in the treatment of autism and other health problems. We must speak out so the FDA knows that consumers rely on these vital medicines.

As a reminder, PCAC advises the FDA in writing new rules regarding what supplements and drugs can be made individually for patients with specific needs by compounding pharmacies. PCAC has met a handful of times over the last few years, and as we’ve noted elsewhere, the track record is not good. The committee has voted to ban almost every compounded natural treatment put before it, including curcumin, boswellia, and aloe vera—usually following the FDA’s recommendation. PCAC meetings are one step in the FDA’s process; to ban an ingredient from compounding requires publishing a proposed rulemaking, which the public can comment on and voice concerns about.

At this next meeting, PCAC will vote on choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin.

Methylcobalamin is tremendously important. It is helpful for a variety of conditions. It promotes brain function, can help with pain, vision, and sleep, mitigates the risk of birth defects, and there is research suggesting B12 can help with depression, rheumatoid arthritis, and Alzheimer’s. There is also research, including randomized clinical trials, showing that methylcobalamin helps with autism by aiding the production of glutathione.

Further, most commercially available B12 comes in two forms (although there are in fact a total of five forms of B12): cyanocobalamin and methylcobalamin. Cyanocobalamin is the most popular because it is cheap to produce and has a longer shelf life.  Once taken, cyanocobalamin needs to be converted into an active form of the vitamin, methylcobalamin or adenosylcobalamin. The problem is that some patients with the MTHFR mutation cannot properly perform this conversion, so they must take methylcobalamin, which is why many integrative doctors prefer methylcobalamin supplementation. About 10-15 percent of Caucasians and 25 percent of Hispanics in the US have this mutation.

Eliminating compounded methylcobalamin would impact the health of many patients, including autistic patients as well as the elderly, who are more prone to B12 deficiency. Both of these groups can have difficulty swallowing pills, meaning another route of administration is needed, which can be prepared by a compounding pharmacy. Patients with allergies to ingredients in methylcobalamin in pill form can have pharmacies make B12 preparations without those allergens.  Methylcobalamin is most frequently compounded for intramuscular injection, which bypasses the digestive system and thus enhances absorption. Sublingual lozenges are commercially sold which also bypass the gastrointestinal (GI) system, but many of these products contain sugar substitutes which can cause GI problems.

Other supplements being considered by PCAC are also very important. Choline chloride can help with atherosclerosis, fetal alcohol spectrum disorders, and liver disease. 5-HTP is a precursor to serotonin, with some evidence suggesting it can help with anxiety, depression, obesity, migraines, and fibromyalgia. Melatonin helps with sleep, even in those with insomnia, and helps with some cancers, among many other benefits. 

Eliminating these medicines limits the tools available to integrative physicians and other natural health practitioners to keep patients healthy, particularly those with special needs who require alternative dosages, non-allergenic ingredients, or delivery mechanisms that are not commercially available. Whittling away the number of medicines that can be legally compounded also makes it difficult for traditional pharmacies to stay in business.   

Action Alert! Write to the FDA and PCAC, urging them not to ban these essential medicines! Please send your message immediately.

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16 responses to “B12 on the FDA’s Hot Seat”

  1. Merle Janes says:

    FDA and PCAC,
    I am an MD and have found valuable outcomes to be had for patients, using Methylcobalamin (B-12).
    Therefore I plead with you to leave this vitamin available to compounding pharmacies so that I can continue to prescribe it.

    Thank you,
    Merle Janes, MD

    • Leslie Henderson says:

      If they won’t listen to Dr’s, REAL DR’S! They won’t listen to anyone! Their agenda is too clear!

  2. Frances Anne says:

    Please leave our supplements alone!

  3. AI says:

    DONT TURN HUMANS INTO CATTLE CAUSE OF HUMAN OVER POPULATION! AND BECOME VEGANS CAUSE ITS WHAT THE EARTH NEEDS NOW.

  4. ed peine says:

    Everyone knows that the FDA is in bed with Big Pharma, and Big Pharma doesn’t like any compound that they make alot of money from!

  5. James D says:

    I am amazed anymore in just how the FDA wants to eliminate the good things that gets in supplements & drugs, as you are pointing out with what’s helping Autism for people. Now I am afraid to speak out much as I have found a B complex which has in it BENFOTIAMINE, as I believe now for at least 11 weeks has helped my neurological condition, ”just saying that for now”. I am all of 61 years old and not 1 neurologists in over the 51 years I have seen them, has ever mentioned BENFOTIAMINE, which I read helped people like me. Any reports you can find about this would be worth putting an article about, as I KNOW it does help brain chemistry & I believe glucose levels in the brain, as it is also to help for diabetics & those with neuropathy, along with some other neurological conditions, like AD where memory can be helped. I suggest to check out mercola.com

  6. Leslie Henderson says:

    Yeah, of course it for our “health” benefit, like the covid, “vaccine” that’s not an actual “vaccine” you know they have no interest in our health when they do this kind of thing, or, anything covid! The culling / depopulation agenda is in full GATES kinda people swing!

  7. Wade McCollough says:

    All I know is since having my 2nd stroke and 7th heart attack if not for b-12 I wouldn’t be here anymore it has helped when nothing did so banning it amounts to killing my progress !!!

  8. Jeanette Stringham says:

    There are many supplements and herbs that are very beneficial to lots of people; that cost less than products from drug companies. They should not be taken off the shelf simply because they compete with drug companies or because a few people have problems with them.. No product is 100% safe. Warning labels are a better solution if its not a significant issue for most people. These products are a resource for those of us that cannot afford many of the drugs out there, who want to avoid negative side effects, or who simply prefer a gentler option. As we know, most drugs come from research on plants and there are new discoveries every day about their medicinal benefits. Please do not try to control herbs and supplements as you do drugs. Classifying herbs as drugs drives up the cost and availability of these items.

  9. Mary Askew says:

    I t makes no sense to me that you you would stop compounded medications and supplements. I have histamine intolerance and cannot tolerate many things with dyes fillers etc. Please let those of us who need compounded supplements and meds have them available to us. It is already a financial burden as insurance will not cover compounded meds.
    Thank you for reconsidering this
    Mary Askew

  10. Adolfo says:

    Do not take away my right to persue good health by taking away my choice to have access to B-12. We, the people are responsible enough manage and do not need Big Government to get invloved.

  11. Concerned American says:

    FDA-Approved Drug Linked to 542 Deaths and 2,367 Hemorrhages, but FDA Refuses to Pull It. The drug is Pradaxa, but methylcobalamin, a safe form of vitamin B12, may be banned from compounding. This is outrageous! A class action lawsuit is warranted!

  12. Kay Cisneros says:

    over the years I have seen how the FDA is slowly getting rid of the competition to Big Pharm. I have many allergies to medicines and most of that is due to fillers in the medicines. And some of the medicines themselves. You are making it harder for me to take care of my health along with my doctor. I resent you telling me what is right for me because not everyone is the same, regardless of what western medicine has decided. I do not absorb a lot of medicines also because I have Celiac disease also. You keep everything at a everyone is the same. I have as much right to be healthy as anyone else. And the way you are going, you are giving me a death sentence.

  13. Jean says:

    I have Pernicious Anemia. I am 72 and was diagnosed with it when I was 31. Without B12 (cyanocobalamine)injections every month for all these years I would not be alive to write this. About 6 months ago I found sublingual Methylcobalamine keeps me from being anemic, so I have not had to get the once a month injections. I cannot understand why anyone that knows anything about it would want to keep this from people like me. We need this to live, period!

  14. Isabel E. says:

    Leave the compounding pharmacies alone, allow them to prepare what the doctors need for their patients. Stop trying to control Professionals care and are trying to keep patient’s healthy.

  15. Bharat Adarkar says:

    To the FDA and PCAC: With reference to choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin, kindly reevaluate your decision to ban these essential medicines!

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