Protect Medical Foods!

In the midst of an opioid epidemic that is killing nearly 100 people every day, the FDA has taken action against a medical food that offers patients an alternative to opioids.

Last November, the FDA posted a warning on its website concerning Limbrel, a medical food marketed by Primus Pharmaceuticals for the management of osteoarthritis. Then, in December, the agency recommended that Primus voluntarily recall Limbrel. The stated reason for the warning is that the FDA is investigating serious adverse events involving Limbrel, including drug-induced liver injury and hypersensitivity pneumonitis. In a letter to Primus, the FDA states that 194 adverse event reports for Limbrel were received between 2007 and 2017—about 20 a year.

Further, FDA asserts that Limbrel doesn’t meet the definition of a medical food. To those familiar with the FDA’s final guidance on medical foods, this should come as no surprise. As we’ve detailed previously, that guidance drastically limits the number of medical conditions that medical foods can claim to help manage. FDA’s examples are restricted to rare genetic conditions that affect a small fraction of people, and are not applicable to patients who have more common disorders, no matter how controllable the condition might be with medical foods.

Given that opioids, including legal drugs like morphine and fentayl, are killing 100 people a day, it is difficult to believe that the FDA is motivated by safety concerns in its actions against Limbrel, a product that could be substantially reducing that death toll. Sadly, it is more likely that the agency is sending a message to the medical foods industry because these products compete with the pharmaceutical drugs that fund the FDA.

Send a message to the FDA urging them to stop the attack on Limbrel, and medical foods in general.

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Please stop the attack on Limbrel and medical foods

Dear [Decision Maker],

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Last November, the FDA posted a warning on its website  concerning Limbrel, a medical food marketed by Primus Pharmaceuticals for the management of osteoarthritis. Then, in December, the agency recommended that Primus voluntarily recall Limbrel. The stated reason for the warning is that the FDA is investigating serious adverse events involving Limbrel, including drug-induced liver injury and hypersensitivity pneumonitis. In a letter to Primus, the FDA states that 194 adverse event reports for Limbrel were received between 2007 and 2017--about 20 a year.

Consider that NSAIDs (non-steroidal anti-inflammatory drugs), an alternative treatment for arthritis, cause approximately 107,000 hospitalizations every year, along with an estimated 16,500 deaths among arthritis patients alone.

Also consider that, in the midst of an opioid epidemic that is killing nearly 100 people every day, the FDA has taken action against a medical food that offers patients an alternative to opioids.

Limbrel's two main ingredients are Chinese skullcap and catechin, a flavanol and antioxidant found in blueberries and other fruits, as well as brewed tea, chocolate, and red wine. Chinese skullcap has been used safely in traditional Chinese medicine for many, many years.

I'm also deeply concerned about the FDA guidance on medical foods. To give a sense for how outrageous the agency's thinking is on this matter, the medical foods guidance specifically excludes diabetes--both type 1 and type 2, as well as gestational diabetes--because, according to the FDA, diabetes can be controlled by simply managing or tweaking one's normal diet.

Restricting medical foods will have real consequences. Merely tweaking one's normal diet is not sufficient to provide enough nutrients to correct certain conditions. Leaving aside our nutrient-depleted soil, there's the fact that many (or even most) people have extremely poor eating habits. Perhaps it's because they haven't been clearly taught about a proper diet for their disease, or perhaps they lack the discipline required to monitor their eating so carefully. Whatever the reason, making a few changes to the standard American diet will almost certainly not be enough to manage conditions like diabetes or nutrient-deficient diseases, whereas medical foods may.

I urge the FDA to stop the attack on Limbrel, an alternative to dangerous opioids, and to amend its guidance on medical foods to be less restrictive.

Sincerely,
[Your Name]
[Your Address]
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[Your Email]