08.02.16
The Food and Drug Administration (FDA), after reviewing Sevani Botanica's website in May 2016, has determined that the Conshohocken, PA-based company is making claims that qualify its products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)].
The products cited in the letter sent to Sheryl Lynn Gibbs, founder, were Advanced Omega Night Repair Serum, Eye Repair Age Defying Eye Crème, Ageless Eyes Revitalizing Eye Serum, and Hyaluronic Wrinkle Defense.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Advanced Omega Night Repair Serum
▪ “Rosewood, and Neroli essential oils offer …cellular regeneration…”
▪ “Evening Primrose: EFA's reduce inflammation and protects from accelerated aging.”
▪ “Neroli blossom: encourages collagen production…”
Eye Repair Age Defying Eye Crème
▪ “Lotus blossom, Neroli and Rose: anti-inflammatory, regenerative…”
Ageless Eyes Revitalizing Eye Serum
▪ “[E]ncourage collagen production…”
▪ “Evening Primrose: anti-inflammatory…”
▪ “Rose Geranium: strengthens capillaries to minimize discoloration”
▪ “Helichrysum: Anti-inflammatory…”
Hyaluronic Wrinkle Defense
▪ “Ideal for Rosacea too!”
▪ “MSM: feeds the formation of collagen and elastin, preventing wrinkles, age spots and redness.”
▪ “Panthenol (B5): anti-inflammatory…”
The letter is dated July 19, 2016.
The products cited in the letter sent to Sheryl Lynn Gibbs, founder, were Advanced Omega Night Repair Serum, Eye Repair Age Defying Eye Crème, Ageless Eyes Revitalizing Eye Serum, and Hyaluronic Wrinkle Defense.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Advanced Omega Night Repair Serum
▪ “Rosewood, and Neroli essential oils offer …cellular regeneration…”
▪ “Evening Primrose: EFA's reduce inflammation and protects from accelerated aging.”
▪ “Neroli blossom: encourages collagen production…”
Eye Repair Age Defying Eye Crème
▪ “Lotus blossom, Neroli and Rose: anti-inflammatory, regenerative…”
Ageless Eyes Revitalizing Eye Serum
▪ “[E]ncourage collagen production…”
▪ “Evening Primrose: anti-inflammatory…”
▪ “Rose Geranium: strengthens capillaries to minimize discoloration”
▪ “Helichrysum: Anti-inflammatory…”
Hyaluronic Wrinkle Defense
▪ “Ideal for Rosacea too!”
▪ “MSM: feeds the formation of collagen and elastin, preventing wrinkles, age spots and redness.”
▪ “Panthenol (B5): anti-inflammatory…”
The letter is dated July 19, 2016.