05.19.16
The FDA’s acting director, New Jersey District, Craig Swanson sent this Warning Letter on May 10th to Stephen Strassler, president of Reviva Labs - stating that the skin care company must take prompt action to correct violations, within 15 days.
According to the FDA, some of the claims on Reviva Labs’ product labels and website reclassify the cosmetic products as unapproved new drugs, according to section 201 of the Federal Food, Drug, and Cosmetic Act.
The FDA’s letter states that the claims and descriptions are in violation because they “are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act.”
And, “introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.”
The Violations
Eight of Reviva’s products were mentioned in the letter: Nasolabial Fold Multi-Peptide Cream, Glycolic Acid Oily Skin Daytime Light Cream Moisturizer, Skin Lightener For Day Fade Cream, DMAE Firming Fluid, Collagen Regeneration Cream, Lighten & Brighten Dark Spot Serum, Spider Vein & Rosacea Day Cream W/Vitamin P, and Vitamin K Cream.
One example of a claim in violation is Reviva Labs’ Nasolabial Fold Multi-Peptide Cream, shown above.
The label states: “Our cream’s complex formula includes…ingredients that can help increase fatty tissue volume to…plump up…”
Reviva Labs’ website states: “Special new peptides and additional ingredients can help increase the volume of fatty tissue…“Hyaluronic acid can help…reduce inflammation…”
Check Your Claims & Labels
Beauty companies must stay up-to-date on the FDA’s regulations - and it can be difficult to know what types of words can and cannot be used on a package’s label, as well as on a brand’s website. Working with a consultant who is a regulatory expert can help ensure your brand's claims are compliant.
According to the FDA, some of the claims on Reviva Labs’ product labels and website reclassify the cosmetic products as unapproved new drugs, according to section 201 of the Federal Food, Drug, and Cosmetic Act.
The FDA’s letter states that the claims and descriptions are in violation because they “are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act.”
And, “introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.”
The Violations
Eight of Reviva’s products were mentioned in the letter: Nasolabial Fold Multi-Peptide Cream, Glycolic Acid Oily Skin Daytime Light Cream Moisturizer, Skin Lightener For Day Fade Cream, DMAE Firming Fluid, Collagen Regeneration Cream, Lighten & Brighten Dark Spot Serum, Spider Vein & Rosacea Day Cream W/Vitamin P, and Vitamin K Cream.
One example of a claim in violation is Reviva Labs’ Nasolabial Fold Multi-Peptide Cream, shown above.
The label states: “Our cream’s complex formula includes…ingredients that can help increase fatty tissue volume to…plump up…”
Reviva Labs’ website states: “Special new peptides and additional ingredients can help increase the volume of fatty tissue…“Hyaluronic acid can help…reduce inflammation…”
Check Your Claims & Labels
Beauty companies must stay up-to-date on the FDA’s regulations - and it can be difficult to know what types of words can and cannot be used on a package’s label, as well as on a brand’s website. Working with a consultant who is a regulatory expert can help ensure your brand's claims are compliant.
