Some products that the company packages are sold under its own Reviva brand, and it’s this collection that has fallen under scrutiny.
The FDA warning letter innumerates several instances where the company’s on-product labels and onsite content makes claims appropriate for drug products rather than cosmetic products.
Regarding Reviva’s Collagen Regeneration Cream, for example, the FDA points to four statements on the company website that would require the products be sold as drugs (rather than as cosmetics) under the Federal Food, Drug, and Cosmetic Act.
Those statements are:
“Stimulating your skin’s own collagen and aiding new collagen production is a different story — and the focus of this cream.”
“Its Palmitoyl Tripeptide-5 sends signals to dermal fibroblasts to synthesize new collagen (the peptide isn’t absorbed to reach fibroblasts; it acts like a messenger).”
“Coenzyme Q10 (CoQ10 or ubiquinone) has antioxidant and anti-inflammatory effects.”
“Coenzyme Q10 can help to stimulate healthy collagen production in the skin, fight free-radical damage (caused by UV exposure)…”
In its response the company says, “it will back away from marketing phrases that imply its products will treat or eliminate various skin problems,” according to Kathleen O’Brian of NJ Advance Media.
Reviva will make changes to its text and eliminate claims that its products “lessen sun damage,” “stimulate healthy collagen production,” “fade or clear bruises,” or “diminish dark spots,” according to O’Brian.
“I believe you will see that we are going beyond your Warning Letter to comply with FDA cosmetic directives for all Reviva products,” says the company in a reply to the FDA, penned by Reviva owner Stephen Strassler.
The changes won’t be immediate. “In his response to the FDA, Strassler indicated it would take some time to come up with new website wording and new packaging designs for the eight products mentioned in the FDA warning,” as O’Brain reports.