Fructis Products From Mexico, South Korea Aloe Gels On FDA Import Alerts

Benton Korea and Ezekiel Cosmetics each shipped 12 products to the US labeled with claims or ingredients, other than aloe, that render them drugs under FDA regulations. Fructis brand hair care products made by two Mexico firms also were detained due to drug claims

Two South Korea firms are the latest targets of orders blocking imports into the US of aloe gel products making drug claims, FDA's most recent import alert update shows.

Products from two Mexico firms shipping Fructis brand hair conditions and shampoos and from dietary supplement and personal care manufacturers in India Thailand also were named in "detention without physical examination" orders noted in the agency's latest update (see table below).

South Korea firms Benton Korea and Ezekiel Cosmetics Co. each shipped 12 products to the US that are labeled with claims or ingredients, other than aloe, that render them unapproved new drugs under FDA regulations, states FDA's import alert update posted July.

Benton Korea's and Ezekiel Cosmetics' product labels and the firms' website include acne treatment and anti-aging claims for creams, moisturizers, toners and other products containing active ingredients salicylic acid 0.5% and glycerin acid at 4% or 6.6%; inactive ingredients as including camellia sinensis and aloe barbadensis leaf waters and "Snail Secretion Filtrate"; and functional ingredients such as arbutin, adenosine and niacinamide, FDA says.

The update also notes orders on four skin care products shipped by a third South Korea firm, Adwin Korea Corp., which initially was cited for making drug claims on similar products in 2015.

FDA in May 31 imposed DWPE orders on Indian aloe product manufacturer Patanjali Ayurved Ltd.'s Patanjali Aloe Vera Gel soap, lotions and other personal care products stating drug claims on labeling or online. (Also see "Aloe Drug Claims Land Indian Firm On FDA Import Alert List" - HBW Insight, 5 Jun, 2017.)

Personal Care And Supplement Manufacturer Import Alerts
Firm / Location	Types Of Products On Import Alert And Reasons	Date Added To DWPE List
HCR Formulations, Moraiya, India	Vitamins, minerals, proteins and unconventional dietary specialties; methyl salicylate; antibiotics; and other drugs / GMP violations	June 9, 2017
Adwin Korea Corp., Seoul	Creams, moisturizers, toners and other skin care products / acne treatment and anti-aging claims	June 19, 2017
Cosbel Sa De Cv, Juarez, Mexico	Fructis brand hair conditioners and shampoos; deodorants; and drugs / claims stated in Spanish include, "saves up to 2000 hairs per month"; "fragile hair that falls fortifies the fiber from the inside to the tips"; and "hair 4X more resistant against the fall."	June 19, 2017
Frabel Sa De Cv, Juarez, Mexico	Fructis brand hair conditioners and shampoos; deodorants; and drugs / claims stated in Spanish include, "saves up to 2000 hairs per month"; "fragile hair that falls fortifies the fiber from the inside to the tips"; and "hair 4X more resistant against the fall."	June 19, 2017
Deltas Pharma(Padmavati), Haridwar India	Basil, natural extract or flavor; vitamins, minerals, proteins and unconventional dietary specialties; joint pain relief oil / "used for common cold, flu, cough, other respiratory and oral cavity ailments"; "have antimicrobial & anti-viral action"; and elixir from basil species is natural adjuvant in opportunistic ailments and prevent frequent recurrence."	June 22, 2017
Padmavati Pharmaceuticals, Haridwar India	Basil, natural extract or flavor; vitamins, minerals, proteins and unconventional dietary specialties; joint pain relief oil / "used for common cold, flu, cough, other respiratory and oral cavity ailments"; "have antimicrobial & anti-viral action"; and elixir from basil species is natural adjuvant in opportunistic ailments and prevent frequent recurrence."	June 22, 2017
Benton Korea, Seoul	Creams, moisturizers, toners and other skin care products / acne treatment and anti-aging claims	July 7, 2017
Ezekiel Cosmetics Co., Gimpo, S. Korea	Creams, moisturizers, toners and other skin care products / acne treatment and anti-aging claims	July 7, 2017
Panya Pisuchpen, Bangkok	Cosmetics; vitamins, minerals, proteins and unconventional dietary specialties; methyl salicylate; antibiotics; and other drugs / GMP violations	July 7, 2017