1401 Eye Street NW, Suite 800, Washington, DC 20005 Michael M. Gaba (202) 772-8496 [email protected] Mr. Seth Casden Chief Executive Officer Hologenix, LLC 1112 Montana Avenue Suite 13 Santa Monica, CA 90403 Re: U.S. Food and Drug Administration Determines Celliant® Products are Medical Devices Eligible for Market and Sale in U.S. Dear Seth: Having reviewed the above-referenced matter, I am pleased to confirm that the U.S. Food and Drug Administration (“FDA”) has determined that Hologenix’ Celliant® products, containing infrared emitting ceramic particles, are regulated as both medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act (“Act”), and are also “general wellness products.” Further, the FDA has concluded that these products present a low risk to consumer safety, and as such, the FDA has chosen not to subject them to any applicable regulatory requirements under the Act, including pre-market notification, and its implementing regulations. In reaching this conclusion, the FDA has correctly recognized that Celliant products serve a medical purpose, “intended to affect the structure and function of the body of man by temporarily promoting increased blood flow at the site of application in healthy individuals.” In the case of Celliant–infused products, the context of the medical device designation is based on the fact that Celliant creates the physiological change in the body described above. In addition, the FDA has defined a general wellness product as one that has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. Therefore, based on Celliant’s capability described above as a medical device to improve blood flow in healthy individuals, the FDA has further acknowledged that Celliant products qualify as general wellness products based upon any combination of the following permissible claims (depending on product type and desired function): polsinelli.com Atlanta St. Louis Boston Chicago San Francisco Dallas Denver Washington, D.C. Houston Wilmington Kansas City

Mr. Seth Casden Page 2 b. Increase thermal energy c. This energy penetrates into the muscle and tissue to promote a temporary increase in local blood flow j. Recycled human energy k. Promotes restful sleep l. Helps increase comfort and promotes restful sleep m. Supports heat generation Moreover, the FDA has authorized the following statement be placed on all marketing materials: “The FDA has determined that Celliant products are medical devices as defined in section 201(h) of the Act and are general wellness products.” Celliant technology may be incorporated into a diverse and broad range of...