US arrests Amazon, others for selling unapproved health products; India sleeps on rampant trade

Even though the United States ultimately strongly criticized its own electronic communications companies, including the biggest player Amazon, over the sale of unapproved drugs and consumer health products, India, a country where trade in line in the health care segment is exploding, seems oblivious to the same. and its imminent dangers.

According to the latest available market data, approximately 14.2% of the sales in India’s $5.70 billion over-the-counter pharmaceuticals market are currently generated through online sales. Online platforms, including multinational giants and local businesses, sell a wide variety of these products, ranging from skincare products to supplements that could “treat” even serious conditions like cancer.

The U.S. Food and Drug Administration, one of the world’s most trusted food and drug regulators, sent warning letters to the nation’s three largest online merchants earlier this week – Amazon , Ariella Naturals and Justified Laboratories – for introducing mole and skin tag removal. some products. The US FDA, while issuing the warning letters, reviewed by the FPJ, said: “…there are no FDA-approved over-the-counter drugs for the removal of moles and skin tags. “

“….it is the duty of the FDA to protect public health from harmful products not approved for the US market. The agency’s rigorous monitoring aims to identify public health threats and prevent these products from reaching our communities. This includes instances where online retailers like Amazon are involved in the interstate sale of unapproved pharmaceuticals. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” said Donald D. Ashley, director of the FDA’s Center for Drug Evaluation and Research compliance office.

Pointing out the dangers of unapproved health products such as mole removers, the FDA warned that moles should be evaluated by a medical professional. “…self-diagnosis and treatment of moles could delay cancer diagnosis and treatment, and even cancer progression…” the FDA said.

The FDA also recently issued a consumer warning that products marketed to remove moles and other skin lesions can cause sores and scarring. The sale of these products poses a risk to public health and may endanger the health of consumers when used without the advice of a health professional.

Curiously, India’s two-tier drug regulatory system – the Central Drug Standards Control Organization (CDSCO) and the state-level FDAs – has yet to act on the threat of rampant e-commerce. unapproved and unauthorized health products.

“…the biggest problem we face when taking action against these electronic communication sites is the lack of clarity in the existing law, which needs to be amended based on changes in business practices,” a senior official said. of drug regulation at CDSCO, seeking not to be identified.

Even though the Central Consumer Protection Authority (CCPA) issued a notice to e-commerce entities in July regarding the sale of certain products in traditional systems of medicine such as Ayurveda, Siddha and Unani, this didn’t really have a serious impact, so insofar as it was a voluntary decision on the part of e-comm.

Mole and skin tag removal products sold on online platforms have not been evaluated by the FDA for safety, efficacy or quality and require FDA approval, according to the US Drug Regulator. . Introduction or delivery for introduction of these products into interstate commerce without an approved application is a further violation of the United States Food, Drug, and Cosmetic Act.

FDA Warning Letters warn companies that failure to adequately address violations cited by the FDA may result in legal action, including seizure and/or injunction. Companies have 15 days from receipt of the warning letter to respond to the agency with the steps they have taken to remedy any violations, the FDA’s letter to companies online says.

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Maria J. Book