FDA inspection identifies shorfallings in use of 'drug' labelling
Reviva Labs, a US-based manufacturer, packer and distributor of cosmetics products, has been sent a warning letter by the FDA after a recent inspection.
The letter outlines issues with regard to the product labels on some of Reviva Labs’ products as well as on its website. The claims on the labels and website indicate that eight of its products, including Skin Lightener For Day Fade Cream and Collagen Regeneration Cream, are classified as drugs under the Federal Food, Drug, and Cosmetic Act.
However, the FDA took issue with the classification of the products as drugs and instead said that because the products are “not generally recognised as safe and effective” for certain uses that their labels claim them to be, they should therefore be classified as ‘new drugs’.
The letter noted that ‘new drugs’ may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA. Craig Swanson, Acting District Director for New Jersey District, who signed off the letter, wrote: “You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.”
In addition to the labelling issues, the inspection also shed light on insanitary conditions at Reviva Labs’ site in Haddonfield, New Jersey. Giving specific examples, a box of vitamin E stick sleeves and bulk products such as Organic Cleansing Milk and Under Eye Dark Circle Serum, were found to be in close proximity to rain water entering the warehouse through a broken bay door.
The date for Reviva Labs to respond to the FDA letter has now passed. Reviva Labs did not respond to Cosmetics Business’ request for a comment.