Protect B12!

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.

Write to the FDA and PCAC, urging them to preserve access to these important compounded supplements.

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Food and Drug Administration
Pharmacy Compounding Advisory Committee

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Please preserve access to methylcobalamin

Dear [Decision Maker],

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Please protect consumer access to compounded methylcobalamin, melatonin, choline chloride, and 5-HTP. These are critically important to many patients with special needs, particularly 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 intravenous administration, which bypasses the digestive system and thus enhances absorption. Sublingual lozenges are 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.

Please preserve access to methylcobalamin and other important supplements!

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
[Your Email]