FDA sends warning to Amazon for selling unapproved mole and skin treatments 

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FDA sends warning to Amazon after regulators discover the retail-giant was illegally selling unapproved mole and skin treatments

  • The FDA has warned Amazon and two other online retailers against selling unapproved skin care products 
  • There are no approved over-the-counter medications that can remove a mole or other skin lesions, the FDA says
  • It warns that some of these products could cause more harm to a person’s skin than a mole itself
  • The products being sold on Amazon were not named in the FDA notice, but the retail giant says that they have since been removed 

Amazon is among three companies who have been warned by the Food and Drug Administration (FDA) for selling unapproved over-the-counter skin and mole removal products.

The retail giant, alongside Ariella Naturals and Justified Laboratories, was issued a warning last week for selling products the agency says weren’t tested for safety or quality of effectiveness. It said that selling these products interstate violates the 1938 Federal Food, Drug, and Cosmetic Act.

What specific products being sold that violates these laws weren’t specifically named.

‘Safety is a top priority at Amazon,’ an Amazon Spokesperson told DailyMail.com. ‘We require all products offered in our store to comply with applicable laws and regulations. The products in question have been investigated and removed.’

The FDA has warned Amazon that over-the-counter skincare treatments being sold on its website are not approved. The retail giant told DailyMail.com that it has removed the products from its marketplace (file photo)

The FDA has warned Amazon that over-the-counter skincare treatments being sold on its website are not approved. The retail giant told DailyMail.com that it has removed the products from its marketplace (file photo)

‘As we get older, we can develop new growths on our skin that we may consider unattractive. These lesions are parts of the skin that look abnormal and include moles, seborrheic keratoses (wart-like growths), and skin tags,’ the FDA said in a statement. 

‘Removing them isn’t a do-it-yourself project, and it can be dangerous to try. Please see a health care provider to have them evaluated and removed, if necessary.’

It notes there are no available over-the-counter treatments for mole or skin lesion removal that have been approved by the agency.

This means that any being sold directly to consumers without need for a prescription are doing so without a regulatory green-light.

These can includes creams, gels, ointments and other products that brand themselves as skin healers.

The FDA warns that using these unapproved, untested, products could lead to significant negative side effects.

‘These risks include skin injuries, infection requiring antibiotics, scarring, and delayed skin cancer diagnosis and treatment,’ it writes. 

‘In fact, the FDA has received reports about people who developed permanent skin injuries and infections after using products marketed as mole or skin tag removers.’

It also writes that many of these issues people are trying to solve are relatively harmless.

The FDA warns some of these treatment to remove moles and other lesions may cause more harm than the actual skin issue was (file photo)

The FDA warns some of these treatment to remove moles and other lesions may cause more harm than the actual skin issue was (file photo)

Moles and skintags can be the sign of cancer or another issue, but sometimes will just form naturally.

If a person does fear that it is dangerous, or if it starts bleeding, is painful, or shows other bizarre symptoms, the FDA advises people to seek medical attention instead of self-treating.

‘Do not treat the skin issue yourself. If you remove it or change how it looks, health care providers may have a harder time determining if it is skin cancer and coming up with an effective treatment plan,’ the agency writes.

‘If a skin cancer is not fully removed, it may continue to grow and possibly spread to other parts of your body. Dermatologists and other skin specialists are trained to identify suspicious lesions, examine them, and help patients decide the best treatment.’

It explains that many of these products use salicylic acid as an active ingredient, which may cause permanent damage when it removes a lesion. The FDA says that the resulting damage could be worse than the original issue itself.

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