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.
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 ensure that licensees are working within their scope of
practice and are using products classified as cosmetics.
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
estheticiansallianceofamerica@gmail.com
512-827-8064
Media Contact
Taylor Cole, Esthetician's
Alliance of America, 1 512-827-8064,
estheticiansallianceofamerica@gmail.com,
https://www.estheticiansallianceofamerica.com
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