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FDA to Ban More Supplements?

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by ANH-USA [2]

An advisory committee is meeting to make recommendations to the FDA on whether or not to ban certain supplements from being made at specialized pharmacies. Action Alert! [3]

On September 12, the FDA’s advisory committee on compounded medicine—medicine made for individual patients at specialized pharmacies—will meet to discuss five ingredients: alpha lipoic acid, CoQ10, creatine monohydrate, pyridoxal 5 phosphate (P5P), and quercetin dihydrate. If the agency doesn’t hear from patients and concerned citizens, we may lose access to individualized preparations of these important dietary ingredients.

The Pharmacy Compounding Advisory Committee (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 [4]. The committee has voted to ban almost every dietary ingredient put before it, including curcumin [5], boswellia, and aloe vera—usually following the FDA’s recommendation.

It’s important to note that 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.

Some of the substances being considered in September are extremely important:

If the FDA bans any or all of these ingredients, it will once again be turning its back on patients with special needs.

One of the main purposes of compounded medicine is so that patients with allergies, patients who have difficulty swallowing pills, patients who require specialized formulations not available elsewhere, such as autistic children, or patients who require other modifications to the dietary ingredients and medicines available in the market can get the individualized treatments they need.

For example, an FDA-approved product may have peanut oil in it, so patients could go to a compounding pharmacy to get a peanut-free medicine. Restricting the list of ingredients available to compounders will make life harder for these patients.

The main motivation behind the FDA’s attacks on compounded medicine is to protect the pharmaceutical industry from competition. With no other choice, patients who rely on compounded medicine would have to buy Big Pharma’s drugs.

We can’t let them whittle away the ingredients allowed to be compounded.

This “death by a thousand cuts” could end access for us to compounding pharmacies altogether.

Action Alert! [3]Write to Congress, the FDA, and PCAC, telling them to preserve consumer access to these compounded medicines. Please send your message immediately. [3]

Read the full article at ANH-USA.org [2].