Company warned for failing to notify the agency of labeling cautions added to the product after the company received more than 168 injury complaints. The maker of Icy Hot Heat Therapy patches has been issued a warning letter from the Food & Drug Administration (FDA) for failing to notify the agency of labeling cautions added to the product after the company received more than 168 injury complaints. Chattem, Inc. recalled Icy Hot Heat Therapy products earlier this year after some consumers suffered burns after using the products.
The FDA warning letter stemmed from an inspection of the company’s Chattanooga, Tennessee plant conducted from Feb. 5 through Feb 8. The Icy Hot Heat Therapy products were recalled on Feb. 8. The FDA said Chattem has 15 days to notify the agency about steps it was taking to correct problems cited in the warning letter.
Icy Hot Heat Therapy products are air-activated self-heating disposable devices
Icy Hot Heat Therapy products are air-activated self-heating disposable devices designed to relieve muscle and joint pain. Chattem recalled the products after it had received some consumer reports of first, second and third degree burns as well as skin irritation related to their use. Involved in the Icy Hot recall were:
- Icy Hot Heat Therapy Air Activated Heat- Back
- Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg
- Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg single consumer use “samples” included on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Crème.
Chattem said that in September it had added more information on the product’s label about how to use them, and it expanded the warnings to help prevent consumers from misusing Icy Hot Heat Therapy. However, according to the FDA warning letter dated June 6, Chattem did not inform the agency of those label changes in a timely manner. The company also did not report some complaints to the agency within the time period required by law.
FDA warning letter also faulted the Icy Hot Heat Therapy products’ label for a number of inadequacies
The FDA warning letter also faulted the Icy Hot Heat Therapy products’ label for a number of inadequacies. For example, the FDA said the label did not properly explain its warnings or caution that certain users such as children should not use the patches. The label also said the patches could be used for “up to 8 hours”, which the FDA said “raises significant clinical concerns as this duration exceeds the established time at which a 2nd degree burn has been shown to occur on human skin at the target temperature of the patch.”