Marci Beauty LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA has reviewed your firm’s website www.spacetouch.com on February 2, 2021 and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed.

Passage 2

The devices listed above are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 3

Our review of your firm’s website at www.spacetouch.com determined your firm is making intended use claims which cause the products to be medical devices under section 201(h) of the Act. These claims include, but are not limited to:

Passage 4

We also note that some of these indications of treating serious life-threatening diseases, such as cancers, dysplasia, hyperbilirubinemia and jaundice, osteoporosis, heart disease, kidney and digestive tract diseases, emaciation and anemia, etc., have not been verified with any clinical data in an FDA marketing application of this device type. These claims could mislead patients and result in the delay or substitution of critical medical treatment, thereby posing further health risks.