$6.17 billion, based on the 2023 Global Aesthetic Medicine Market Analysis, but no less than 10%-15% of it is fake. Fake Botox not only decreases the level of treatment but also creates side effects in more than 30% of patients, such as rigidity of the face, nerve damage, and swelling in the area where it is injected. Security-wise, total authentication of Botox at every level, whether packaging and shipping or anti-counterfeit protection, is unavoidable.
Characteristics of Genuine Packaging
has over 20 million unit volume of global sales, not to mention strictly controlled supply channel with multiple audits within each pack. Original Botox is embossed with anti-counterfeiting high-definition print, and possesses clearly marked, in turn, the serial numbers, manufacture dates, and batch numbers, along with identical ones on the vial. The counterfeit Botox consists of over 85% and features insignificant differences in minutiae, e.g., slightly indistinct fonts, off-center reproductions of the batch numbers, or in hue (grayish or purplish shade).
Compositions inside the vial also contribute to identification. Authentic Botox is contained in transparent medical-grade glass vials capped with silver-gray aluminum caps and purple plastic ones. The imitations are thicker-walled, thinner-capped, and sometimes no aluminum seal at all. Lab tests also show that 73% of the counterfeit Botox vials have loose or thinner caps which are not such a tight seal, hence the contents would be open to contamination. The real product should be a white lyophilized powder that would accumulate at the bottom of the vial when standing the vial upright. Yellow material, granular, or in solution is likely counterfeit. A 2022 on-site inspection found 68% of the counterfeit Botox clumped upon opening, some having fillers the FDA does not know about, which can infect patients.
How to Check with QR Codes
Pharmacologically, technology for drug counterfeiting has come a long way in the past few years and, hence, each packet of Botox includes a unique QR code that can be scanned officially. According to 2023 drug tracking system statistics globally, over 50,000 instances of the counterfeits of Botox were caught and identified that 42% of the QR codes were not traceable on the official system, i.e., the majority of the counterfeits are now easily traceable at this point.
Official verification processes must be adopted. The Botox can be checked using the QR code or manually by entering the serial number in the official website or App after purchase to check whether the product is genuine or not. Official database update stores more than 30 million batch records every year and has an accuracy rate of 99.8%. If the QR code is not pointing to an official website or is not corresponding to the batch number, then it is a counterfeit product.
A counterfeit Botox contains a forged QR code, but there are vulnerabilities. For 2023, 21% of the counterfeit Botox contained duplicate serials, where they had more than one product with the same verification code. Second, 39% of the counterfeit Botox QR codes had errors and didn’t redirect any page. The genuine Botox batch numbers utilized in the Chinese market are verifiable from the NMPA website, and over 20,000 counterfeit Botox products are reported every year.
General Counterfeit Situations
Most common are brand-mimicry fake Botox, followed by low-concentration and then poor-quality fakes are fillers. The fakes share similarities, i.e., their prices are significantly lower than the market price, unstable efficacy, and even toxic effects.
Most common is brand-mimicry Botox. In the 2023 Global Aesthetic Medicine Industry Report, over 150,000 vials of fake Botox were confiscated globally, and over 65% replicated official package templates. The fake drugs are typically printed in the same color, font, and batch numbers as genuine ones but with inferior quality anti-counterfeiting labels, and varying materials in vial caps. Besides this, Russia, Turkey, and India are the major sources of Botox fakes, and the Russian market alone has 24.6% of counterfeiting, a high-risk area for Botox distribution fakes.
Low-concentration Botox is also prevalent counterfeiting. Real Botox is a 900kDa complex neurotoxin that acts to relax the muscle 3-6 months after the injection. But it has also been discovered in studies that 78% of counterfeit Botox has an average size of less than 300kDa, thus leading to treatment failure or no result at all. Low concentration copy Botox treatment failure can reach 47%. Better still is the realization that low-toxin content regimen fake Botox will trigger the body to reject subsequent real Botox therapy.
Logistics Tracking Tip
Botox is sold in 120 countries, and more than 95% of counterfeit Botox reaches the market by entering black channels in the forms of personal representatives, internet-selling websites, or buying through social websites online.
Shipping in a cold chain is one of the most basic Botox requirements. Original Botox is to be kept at 2°C-8°C and has temperature control stickers. The potency of Botox reduces by 56% when the temperature exceeds 25°C for 48 hours. More than 80% of fake Botox does not have cold chain shipping, and it is guaranteed that the product has already deteriorated and lost its potency. Original Botox shipments come with customs certificates of clearance, batch reports, and import registration. Absence of these suggests that there is a high chance more than 87% of a product is counterfeit.
Emergency Handling
Should the Botox be suspected to be counterfeit, the initial reaction is an immediate stop in its use and authentication. Figures indicate that 62% of users of counterfeit Botox develop side effects within two weeks, ranging from facial redness, allergic contact dermatitis, stiffness, to treatment failure. If the Botox is already ingested, one is asked to go to an accredited medical facility within 24 hours. Doctors can diagnose with imaging procedures and a blood test whether the toxic chemicals are in the body and treat the patients as such. Clinical trials showed that 14% of fake Botox injections can lead to potentially lethal allergic reactions like swelling of the throat, blurring of vision, and muscle weakness. Symptoms require urgent hospitalization.
If fake, customers can report to the FDA, NMPA, or local administrative department. More than 45,000 complaints regarding Botox were reported worldwide in 2023 alone, and 72% of them were resolved positively through legal action.
Rights Protection Channels
It has over 1,200 authorized distributors of Botox globally, and purchasing from authorized suppliers reduces the risk of purchasing counterfeit injection. If customers buy counterfeit Botox, they can report to the National Medical Products Administration, FDA, or consumer protection agencies. Incidents of counterfeit Botox increased by 38% in the past five years globally, and 89% of the incidents were addressed by the official authorities.
