Protecting Your Practice: The FDA's Counterfeit Botox Alert and Legal Risks of Cosmetic Product Origins.

The FDA recently issued a warning on 5-1-2024 to medical and aesthetic industry professionals on the presence of counterfeit botox in both licensed and unlicensed settings.

"The products appear to have been purchased from unlicensed sources. Medications purchased from unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe."

As the medical aesthetic industry continues to expand, the growing need for sourcing cosmetic and medical products such as Botox, hyaluronic acid fillers, fat dissolvers, and chemical peels etc., increasingly sparks opportunities for unauthorized distributors to market these products.They often do so under identical packaging or as "off-brand" alternatives sourced from overseas manufacturers, posing significant risks to both providers and patients in the industry.

Federal law prohibits non–FDA-approved drug importation. For aesthetic professionals, it is crucial to understand that the legality of purchasing products for professional use heavily depends on how the FDA classifies these products. The classification determines whether a product is considered a drug, or a cosmetic.

The aesthetic industry has a long history of 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 actually 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", which is often the means in which manufacturers can import products through a cosmetic labeling. Although in actuality, the ingredients or concentrations might be mislabeled, and categorically be considered drugs, and therefore violating federal law.

In an aesthetic professional setting, it is essential for the individual 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, INCI, or have active FDA approval/registration.

For estheticians, 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, since the ambiguity of ingredients or concentration levels claiming to be are cosmetic in nature, might actually be classified as drugs by the FDA, therefore causing an esthetician to illegally be practicing medicine. To avoid using products misbranded "cosmetics" it's crucial to understand how the FDA registers and classifies cosmetics. In 2022, the announcement was made that the "Voluntary Cosmetic Registration Program" (VCRP) would be replaced by the "Modernization of Cosmetics Regulation Act of 2022" (MoCRA). For estheticians, this means that the way to verify a brand or product as a cosmetic suitable for use in your scope as a non-medical professional will change starting July 1, 2024. The VCRP cosmetic database been discontinued to prepare for a new database called Cosmetic Direct. The purpose of the FDA's upcoming "Cosmetic Direct" tool will be to access and verify cosmetic products' information and a manufacturer's (or processor's) registration status. The modernization of cosmetic classifications and online information access will hopefully mitigate the risks or uncertainty for esthetician's on what is or is not a "beautification" product— a common pain point for Cosmetology State Board's as they navigate the uncertainty of classification of new products and treatments being offered by licensees in their state.

Sourcing unverified cosmetic products for professional aesthetic use, such as acne "treatments", from overseas manufacturers could potentially violate FDA regulations. If these products contain certain concentrations of ingredients considered to be drugs by the FDA, (Such as prescription levels of benzoyl peroxide) and technically should require a prescription, this could lead to serious repercussions, including the removal of the esthetician's license. Ensuring compliance with FDA standards is crucial for maintaining professional integrity, client safety, and not performing "medicine" without the license to do so.

"When the FDA's "Cosmetic Direct" tool is published, the Esthetician's Alliance of America strongly urges all estheticians to use this tool. Proper verification through Cosmetic Direct will ensures that licensees are working within their scope of practice and using products classified as cosmetics." -Esthetician's Alliance of America

For medical professionals, purchasing Botox or other drugs from legitimate overseas sources to save money can expose them to substantial legal risks. This practice of aesthetic medical professionals of importing Botox (counterfeit or legitimate) from oversees is called "Parallel importation" Parallel importation is a practice where pharmaceuticals are bought from countries with regulated drug prices and sold in the U.S. at lower costs, and presents significant risks for aesthetic medical professionals. The U.S. Supreme Court ruled in 2013 that parallel importation is legal in "general" terms, but importing drugs not explicitly intended for U.S. use remains illegal.

(The Supreme Court case that ruled "parallel importation" as a concept was broadly legal, although the case had to do with importation of textbooks, not aesthetic drugs)

This creates a complex legal landscape for those in the aesthetic industry looking to save on costs by purchasing from overseas.

Countries like the United Kingdom, Germany, France, Sweden, and Canada have government regulations that keep drug prices in check. Licensed dealers in these countries can sell pharmaceuticals, including Botox used in elective procedures, at significantly lower prices than in the U.S. Buyers benefit from these cost savings, and the imported drugs are genuine and FDA-approved. However, despite these apparent advantages, purchasing through parallel importation can lead to severe legal issues.

Medical professionals who engage in parallel importation risk criminal charges and professional penalties. For instance, in June 2018, Oregon-based physician Brenda Roberts faced the revocation of her medical license for purchasing Botox from overseas sources. Although the drugs were legitimate, their use in the U.S. was unauthorized. Proper authorization is required to ensure drugs like Botox are handled, refrigerated, and transported to the United States' standards for drug safety and efficacy.

The CDC released a public notice on 4-23-2024 on both the adverse effects and risks of mishandled and counterfeit Botox. Adverse effects of Botulism (a disease caused by botulinum toxin circulating in the blood) and 11 hospitalizations have been reported.

The CSC reports "These adverse events have been linked to improper procurement and administration of botulinum toxin".

Medical professionals should remain diligent of online distribution of aesthetic drugs, even with seemingly legitimate distribution operations. In recent years, there have been cases of companies with incredibly large distribution in the US that were found to be selling misbranded products.

In 2015, wholesale distributors TC Medical Group and SB Medical Inc. were found guilty of illegally distributing misbranded pharmaceuticals, including Botox and Juvaderm, in the United States. The proceeds from these illegal activities totaled over $33 million. Court documents revealed that sales representatives David E. Burke and Hanoch David Stein were involved in shipping misbranded Botox and Juvaderm to various doctors in the United States. The shipments from the distributors, intended for use in the Philippines or other countries, often arrived unrefrigerated, one the main dangers of pharmaceuticals brought into the country through "parallel importing". The court documents cited numerous violations, including a communication from a doctor stating 5 out of 10 clients experienced side effects from Botox injections requiring several of them to go to the emergency room “because the side effects were too strong.” David E. Burke, who previously used the pseudonym "David Johnson" during his time at TC Medical Group and SB Medical, continues to operate an aesthetic distribution company called Bioskin Aesthetics, despite past controversies.

Practices such as parallel importing can compromise the safety and efficacy of the drugs, posing significant risks to patients. The United States enforces strict regulations to prevent these hazards, ensuring that all pharmaceuticals meet rigorous standards for transportation and storage to protect public health.

Federal agencies do not take such violations lightly either- sentencing TC Medical Group conspirators to 26 months in federal prison. For resources on how to protect patients in your aesthetic practice from unsafe drugs, read the FDA's "Know Your Source" Guide

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 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.