The soaring demand for new anti-obesity medications has led to a concerning trend, with various online companies attempting to sell these “must-have” drugs without proper approval or prescription, prompting the FDA to take action. The FDA recently issued warning letters to two companies, Semaspace and Gorilla Healing, instructing them to cease selling online versions of semaglutide and tirzepatide.
Semaglutide is the key component in Novo Nordisk’s Wegovy, a weight loss drug, and its diabetes portfolio. Tirzepatide, on the other hand, serves as the active ingredient in Eli Lilly’s diabetes medication, Mounjaro, which is also seeking approval for its weight-loss application.
In these letters addressed to both companies, the FDA emphasized the inherent risks associated with consumers purchasing drugs online without a prescription. It stressed that unapproved medications lack the same level of safety and effectiveness assurance as FDA-regulated drugs. The FDA’s primary objective is to safeguard the public from potential harm by demanding that these companies cease offering unapproved and misbranded drugs to US consumers.
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Furthermore, the FDA requested that the companies thoroughly review their product labeling, promotional materials, and websites to ensure that they are not misleadingly representing the safety and effectiveness of these products.
The companies have been given until the end of the month to provide explanations. Failure to do so may lead to legal action initiated by the FDA, including the possibility of seizure and injunction.
This development occurs against the backdrop of a significant surge in demand for FDA-approved versions of these weight loss drugs. Notably, prominent figures like Elon Musk, the owner of X, and others have publicly endorsed these drugs, citing their use in aiding weight loss.
Also Read: Eli Lilly Sues 8 Companies For Selling Fake Mounjaro Versions
While Lilly has yet to secure FDA approval for Mounjaro as an anti-obesity therapy, it aims to obtain the green light by the end of the year. Novo Nordisk, on the other hand, has faced challenges meeting the surging demand for Wegovy, which led to a temporary hold on its marketing efforts due to strain on manufacturing services for the drug.
