The FDA is at it again. If you have been advertising (even on your website) that you treat anything other than the “approved indications” and you haven’t seen a “WARNING LETTER” from the FDA yet – IT WONT BE LONG before you do. The age of regulation is upon us and the government needs to have a “return on investment” (ROI) for the hiring the largest number of regulators in US history. Good, bad, or indifferent, everyone in the industry will be affected by this crackdown- even if you are doing everything correctly. It will only take one bad news article about HBOT and down goes the reputation of the therapy. I am sure you are asking yourself “What does the FDA have to do with my advertising of my facility or my chambers?” This is from the FDA’s website:
FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law.
In addition, FDA advances and encourages better communication of labeling and promotional information to health professionals and to consumers.
Please do remember that hyperbaric chambers are “cleared” by the FDA and that the FDA also monitors and can regulate the advertising of “off-label” indications to the consumers. I am sure one can argue that the FDA has no right to tell a physician what they can and cannot treat in their chambers but they do seem to have the right to monitor unsubstantiated claims about what HBO can and cannot treat.
In case no one has seen Title 21 (good reference). I hope you enjoyed this update.
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES
Subpart F–Therapeutic Devices
Sec. 868.5470 Hyperbaric chamber.
(a)Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient’s tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (878.5650).(b)Classification. Class II (performance standards).