London-based Medical Specialties of California UK has sold its Penguin Cold Caps in the U.S. for the purpose of reducing hair loss for chemotherapy patients, according to FDA. Santa Ana, Calif.–based Rapid Release Technologies has meanwhile gone beyond the claims of standard therapeutic vibrator and heat pad devices when it comes to its RRT PRO2, FDA said.
FDA is ordering both companies to stop distributing the products for the uses discussed in the warning letters.
Phone calls and emails to officials at both companies were not immediately returned.
The Penguin caps were actually the subject of a New York Times Well blog post in 2015. The caps at the time cost a few hundred dollars a month to rent, added 2 additional hours to chemotherapy sessions, and could be uncomfortable. But the people who used them swore by them, saying the caps helped them preserve their privacy by doing away with one of the most noticeable side effects of chemotherapy: hair loss.
Many cancer patients in Europe have used the caps, and the company has pointed to research backing up the effectiveness in the caps. Kept in a freezer before use, the caps are supposed to reduce the effects of chemotherapy by slowing the metabolic activity of hair follicles and constricting blood flow to the hair.
Penguin makes the caps with medical grade hypo-allergenic plastics on the underside, with a blue nylon covering. A special formulated crylon gel is inside the cap.
Rapid Release Technologies meanwhile boasts that a leading chiropractor designed its Rapid Release Pro-2, which presently sells for $1,495.
FDA, though, said Rapid Release Technologies is going beyond the claims usually made by makers of therapeutic vibrators and powered heating pads, which are supposed to relax muscles and relieve minor aches and pains.
Rapid Release Technologies, according to FDA, is “marketing the RRT PRO2 for different intended uses, namely for the release of soft tissue, relaxation of muscle guarding (e.g., protective response in muscles that results in co-contraction due to pain or fear of movement), spasms and cramps, increasing circulation, claims associated with scar tissue, mechanically affecting fascia for increasing movement, headaches, nerve or joint pain, anxiety, digestive disorders, fibromyalgia, insomnia, and hypoxia.”
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