The Esthetician's Alliance of America issues an advisory with guidance for medical and esthetic industry professionals during the International Esthetics, Cosmetics, and Spa Conference (IECSC Las Vegas). The organization provides the FDA's counterfeit botox alert and the legal risks of cosmetic product origins.
LAS VEGAS, June 21, 2024 /PRNewswire-PRWeb/ -- The Esthetician's Alliance of America issues an advisory with guidance for medical and esthetic industry professionals in advance of the International Esthetics, Cosmetics, & Spa Conference (IECSC Las Vegas), presented by American Spa. The organization highlights the FDA's counterfeit Botox alert and legal risks of cosmetic product origins.
On May 1, 2024, the FDA issued a warning to medical and aesthetic industry professionals regarding the presence of counterfeit Botox in both licensed and unlicensed settings. This advisory underscores the importance of vigilance in sourcing cosmetic and medical products to ensure the safety and legality of treatments.
The medical aesthetic industry is experiencing significant growth, leading to increased demand for products such as Botox, hyaluronic acid fillers, fat dissolvers, and chemical peels. This demand has unfortunately opened the door for unauthorized distributors to market these products, often under identical packaging or as off-brand alternatives sourced from overseas manufacturers. These products pose significant risks to both providers and patients.
Federal law prohibits the importation of non-FDA-approved drugs. Aesthetic professionals must understand that the legality of purchasing products for professional use heavily depends on how the FDA classifies these products, determining whether a product is considered a drug or a cosmetic.
The aesthetic industry has long faced ambiguity regarding what is technically considered a cosmetic versus a drug. Without FDA approval or registration, an aesthetic treatment product marketed and sold for professional use might fall into the category of a drug, despite claims of being a cosmetic. This distinction is vital for ensuring compliance and avoiding legal pitfalls.
The FDA does not strictly regulate or require testing on products considered cosmetics, often allowing manufacturers to import products under cosmetic labeling. However, ingredients or concentrations might be mislabeled and categorically considered drugs, thus violating federal law.
In an aesthetic professional setting, it is essential for individuals responsible for procuring cosmetic or aesthetic medical products to verify the legitimacy of distributors through the manufacturer. This verification process should ensure that the products are either voluntarily registered in the FDA's cosmetic databases, The International Nomenclature of Cosmetic Ingredients (INCI), or have active FDA approval and registration.
Using unverified cosmetics on clients can pose significant risks, akin to those associated with counterfeit or unregistered medical drugs like Botox. This is particularly concerning for unregistered cosmetic products, as the ambiguity of ingredients or concentration levels claiming to be cosmetic might be classified as drugs by the FDA, causing an esthetician to illegally practice medicine. Understanding how the FDA registers and classifies cosmetics is crucial to avoid misbranded products.
In 2022, it was announced that the Voluntary Cosmetic Registration Program (VCRP) would be replaced by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Starting July 1, 2024, estheticians will need to verify products as cosmetics suitable for use in their scope of practice through the new Cosmetic Direct database. This modernization aims to mitigate the risks or uncertainty regarding cosmetic classifications, a common challenge for Cosmetology State Boards.
Sourcing unverified cosmetic products from overseas manufacturers could potentially violate FDA regulations. If these products contain certain concentrations of ingredients considered drugs by the FDA, they should require a prescription, leading to serious repercussions, including the removal of the esthetician's license. Ensuring compliance with FDA standards is crucial for maintaining professional integrity and client safety.
"When the FDA's Cosmetic Direct tool is published, the Estheticians Alliance of America strongly urges all estheticians to use this tool. Proper verification through Cosmetic Direct ensures that licensees are working within their scope of practice and using products classified as cosmetics," advises the Estheticians Alliance of America. https://www.fda.gov/drugs/information-health-care-professionals-drugs/know-your-source-protecting-patients-unsafe-drugs
For medical professionals, purchasing Botox or other drugs from legitimate overseas sources to save money can expose them to substantial legal risks. This practice, known as "parallel importation," involves buying pharmaceuticals from countries with regulated drug prices and selling them in the U.S. at lower costs. However, importing drugs not explicitly intended for U.S. use remains illegal.
- In June 2018, Oregon-based physician Brenda Roberts faced the revocation of her medical license for purchasing Botox from overseas sources. Despite the drugs being legitimate, their use in the U.S. was unauthorized. Proper authorization is required to ensure drugs like Botox meet the United States' standards for safety and efficacy.
- On April 23, 2024, the CDC released a public notice on the adverse effects and risks of mishandled and counterfeit Botox, reporting cases of botulism and hospitalizations linked to improper procurement and administration.
- In 2015, SB Medical Inc. and TC Medical Group, based in Toronto, Canada, and St. Michael, Barbados respectively, were found guilty of illegally distributing misbranded pharmaceuticals in the U.S., including Botox and Juvaderm. This resulted in substantial fines and forfeitures amounting to $75 million in total. These companies were involved in a multi-year conspiracy to smuggle and sell these misbranded drugs, generating over $33 million in illegal proceeds. The misbranded pharmaceuticals were sourced from various foreign countries, including India, Turkey, France, and Italy, and included a range of products from orthopedic injections to oncology drugs. David E. Burke, one of the individuals implicated in this conspiracy and known to have used the alias "David Johnson," continues to operate a U.S. aesthetic distribution company named Bioskin Aesthetics despite these past controversies. https://www.justice.gov/usao-edva/pr/canadian-companies-fined-45-million-and-ordered-forfeit-additional-30-million-smuggling
The aesthetic industry must remain vigilant against the use of misbranded and counterfeit products to ensure the safety and efficacy of treatments. For estheticians, understanding the FDA's classification of cosmetics and utilizing resources like the upcoming Cosmetic Direct tool is crucial in maintaining compliance and protecting clients. Medical professionals must avoid the risks associated with the parallel importation of drugs, which can lead to severe legal and health consequences. By adhering to verified sources and maintaining rigorous standards, professionals in the aesthetic industry can uphold their commitment to client safety and professional integrity.
Learn more here: https://www.estheticiansallianceofamerica.com/post/the-fda-s-counterfeit-botox-warning-the-perils-of-off-brand-counterfeited-or-mishandled-aestheti
About Esthetician's Alliance of America
The goal of the Esthetician's Alliance of America is to empower estheticians with the knowledge they need to make informed purchase decisions on equipment and products. By providing access to reliable and up-to-date information, Estheticians Alliance aims to support the economic advancement of the professionals they serve. They strive to be a trusted resource that estheticians can rely on for guidance and clarity in their practice.
For more information, please contact:
Esthetician's Alliance of America
estheticiansallianceofamerica.com
512-827-8064
Media Contact
Taylor Cole, Esthetician's Alliance of America, 1 512-827-8064, [email protected], https://www.estheticiansallianceofamerica.com
SOURCE Esthetician's Alliance of America
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