A federal judge sided with the FDA on Tuesday and ordered New Jersey-based Flawless Beauty to stop importing and selling a range of injectable skin-whitening products and to recall and destroy all of the firm’s current stock.
The company has also been ordered to recall and halt the sale of a range of other products, including whitening creams and lotions marketed as being made with placenta and stem cells, “slimming” creams, skin peels and even a “whitening” roll-on deodorant.
According to the FDA, the products are imported by a direct subsidiary of Flawless Beauty from countries including the Philippines, New Zealand, China and Japan and sold over the web and via direct telephone orders.
A representative of Flawless Beauty, which is owned by Jack Gindis and Susana Boleche, could not be reached for comment. The company is active and popular on social media, with more than 35,000 followers on Instagram and close to 1.1 million followers on Facebook.
You May Also Like
The agency argued earlier this month that the products are not only unapproved, but “misbranded” and pose “serious public health risks,” especially the allegedly skin-whitening injectables, which can cause nerve damage and be toxic when needles are not sterile or the drug is administered improperly.
Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said the agency gave Flawless Beauty “repeated warnings” about the products, but they were ignored.
Ashley added that the FDA wants consumers to “beware these and other unproven drug products that use deceptive marketing tactics to sell their unsafe products.”
As for the topicals being imported and sold, the agency said they are considered “new drugs” because they are “not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested in their labeling.”
The agency noted that Flawless Beauty has no drug or product approval applications on file.
An FDA spokeswoman declined to comment on any further enforcement efforts in the beauty industry.
Flawless Beauty says on its web site that it’s “the source for natural skin care” and that its skin-care, whitening and weight loss products “must meet rigorous safety standards before being made available to the public.” However, the company offers no details on the standards or where and how they are met.
The beauty and cosmetics industry is largely unregulated and the FDA only has power to approve certain products that contain ingredients such as color additives, but products such as shampoo and antiperspirants marketed as having some kind of medicinal effect do fall under its regulatory umbrella.
This leaves the industry self-regulating many of the ingredients used in cosmetics products – and, under FDA rules, consumer complaints a company may receive about its products do not have to be reported to the agency.
Still, consumer complaints to the FDA have been increasing in recent years. In 2016 the FDA received close to 1,600 consumer complaints about adverse “events” stemming from beauty products, mainly cosmetics and skin care. In the previous decade, the FDA received only 5,000 complaints.
Recognizing the strange lack of oversight of an industry estimated to be doing $60 billion in annual business in the U.S. alone, Sens. Dianne Feinstein, D-Calif., and Susan Collins, R-Maine, in May introduced the Personal Care Products Safety Act.
The proposed legislation calls for an expansion of the FDA’s authority to cover ingredients in all personal care products, safety rules for which haven’t been updated since 1938.
For More, See: