The U.S. Food and Drug Administration (FDA) sent seven warning letters to cosmetics companies in September 2016, continuing the agency’s trend of clamping down on what it contends are unapproved drug claims for cosmetic and personal care products.
A letter to Zo Skin Health Group, LLC targeted three products, including the company’s Ossential® Growth Factor Serum Plus, Ossential® Daily Power Defense and Ossential® C-Bright Serum 10% Vitamin C. FDA highlighted website claims such as “Helps stimulate cell renewal” and “Helps prevent new pigment from forming,” which the agency said estab- lishes the products as drugs under the Federal Food, Drug, and Cosmetic Act.
Another company that received a letter, Tata’s Natural Alchemy, LLC, sells products online that include Boosted Contouring Eye Mask & Rejuvenating Serum, with the claim, “2 hours: RELAX MUSCLE, 95% of wrinkle-causing muscle contractions decrease.” FDA’s letter high- lighted several other products on the company’s website, including a Concentrated Brightening Serum with the claim, “A blend of targeted technology…to fighting every stage of the hyperpigmentation process, by helping to inhibit the passage of melanin to the surface…” and “24 hours: REDUCE MELANIN Test studies show a reduction in the skin’s melanin content by 36%*.”
Healing-Scents, which sells oils and herbs (among other products), also received a warning letter. FDA pointed to claims about Neem Seed Oil on the company’s website such as “Neem produces pain-relieving, anti- inflammatory and fever reducing compounds that can aid in the healing of cuts, burns, sprains, earaches, and headaches, as well as fevers.”
The letter also noted claims about the company’s Heart Herb that FDA cited as evidence that the product is intended to be used as a drug. For example, “Use of this blend may help prevent and/or reduce the symp- toms of many heart disease related conditions, including atherosclerosis, angina, neuritis, neuralgia, rheumatism, liver problems, arteriosclerosis, prevent coronary heart disease, congestive heart disease…”
Nineteen warning letters for cosmetic and personal care product claims have been posted since June of this year.