In a warning letter published on FDA's website May 2, the agency identifies two Ageless Derma products as unapproved new drugs due to label and website claims touting body structure/function effects. The laundry list of offending claims offers a resource for companies to use in their own claims-compliance efforts.

Businesses must provide proper disclosures to online consumers who enroll in auto-renewal purchasing or subscription programs or risk facing litigation in California and other states, according to Tucker Ellis attorney Ronie Schmelz. Birchbox is among companies that have been targeted for alleged violations of California law designed to protect consumers from being charged for continuous product shipments or ongoing services without their express consent and ability to cancel easily.

Claims promoting Cell Vitals’ ReLuma skin-care line render the products unapproved drugs, FDA asserts in a Nov. 24 warning letter. Marketed as “A Revolution in Stem Cell Skin Care,” the firm’s products feature cytokines and growth factors harvested from adult stem cells that send “grow and divide” signals to aging skin cells, the company says.