FDA Threatens to Take Action Over Claims by St. Ives
Food and Drug Administration officials are threatening to take action against a Chatsworth shampoo and skin-care company unless it stops selling a beauty cream that it claims “helps reduce the visible signs of aging.”
In an Aug. 31 letter to St. Ives Laboratories, George J. Gerstenberg, district director of the FDA in Los Angeles, demanded that the company stop selling its Retinyl-A cream, accusing St. Ives of “false and misleading” labeling of the product. Gerstenberg added that because St. Ives claims the cream reduces aging signs, he considers it a drug subject to federal food and drug regulations.
“Further, we are unaware of any substantial scientific evidence which documents that this drug is generally recognized as safe and effective” for use in treating signs of aging, Gerstenberg said in the letter, sent to St. Ives Chairman Gary H. Worth. A copy of the letter was made available to The Times by the FDA.
Gerstenberg said St. Ives is violating federal food and drug laws by suggesting on its labels that there is evidence to support its claims. He noted in the letter that federal law allows the FDA to seize illegal products and to seek court orders to stop the making and distribution of them.
John L. Boyle, St. Ives chief financial officer, said Friday that the company responded this week with a letter disputing Gerstenberg’s accusation that it is misleading consumers.
Rival Filed Suit
Boyle said Retinyl-A is a beauty product, not a drug, that should be sold with such products as moisturizers. He said the company has sold about $2 million of the cream, which retails for $6 to $8 for a 3.8-ounce bottle, since introducing it this spring.
St. Ives is already being sued over Retinyl-A in Los Angeles by Johnson & Johnson’s Ortho Pharmaceutical Corp. subsidiary in Raritan, N.J., which claims that St. Ives is taking advantage of widespread publicity given this year to Ortho’s Retin-A product after a study suggested it might be an effective anti-wrinkle cream.
Ortho accuses St. Ives in the trademark-infringement lawsuit of a “fraudulent marketing scheme designed to dupe the public” because St. Ives gave its cream a similar name to Retin-A and because it claims on bottles and in advertisements that the product is “a breakthrough in skin care!”
Retin-A is an Ortho prescription drug for acne that contains tretinoin, or retinoic acid, which is a relative of vitamin A. A highly publicized study in January that appeared in the Journal of the American Medical Assn. found it helped reverse the premature aging of skin by sunlight.
Disputes Claim
St. Ives’ Boyle said there are no similarities between Ortho’s Retin-A and St. Ives’ Retinyl-A, which contains retinyl palmitate, a vitamin A derivative commonly found in over-the-counter moisturizers.
Boyle said that the company does not believe that consumers are confused by the two products, but said St. Ives would consider changing its labels to satisfy the FDA and Ortho.
