The product is risky! Amazon received a warning letter from the FDA

The product is risky! Amazon received a warning letter from the FDA

Amazon has a huge number of products with a wide variety of categories. The huge number of products means that it is difficult to manage, and it is inevitable that some products will slip through the net.

 

Recently, the U.S. Food and Drug Administration ( FDA) sent a warning letter to Amazon because the products sold on its platform violated the provisions of the Food, Drug, and Cosmetic Act.

 

The FDA said that based on their investigation, products labeled as energy supplements or dietary supplements on Amazon contained undisclosed but potentially dangerous drug ingredients, including sildenafil and tadalafil.

 

The FDA said in the warning letter that it was surprising that these important ingredients were not listed on the labels of these products. Among them, sildenafil and tadalafil are powerful phosphodiesterase type 5 inhibitors, which are common ingredients in Viagra and Cialis.

 

The danger of these undisclosed ingredients is that they may interact with nitrates commonly found in drugs such as nitroglycerin. However, consumers with diabetes, high blood pressure or heart disease need to take nitrate drugs for a long time, and the reaction between the two substances can cause the user's blood pressure to drop.

 

The FDA noted in the warning letter that failure to disclose these ingredients in the product labeling would result in the product being improperly branded, pursuant to Section 502(a) of the Food and Drug Administration Act.

 

FDA added that further introduction or delivery of these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FDA Act, 21 U.S.C. 331(a), 331(d), and 355(a), and introduction or delivery of food for introduction into interstate commerce is prohibited under section 301(ll) of the FDA Act.

 

In a Dec. 20 letter to Amazon CEO Andrew Jassy, ​​the FDA requested a response within 15 business days of receiving the warning letter.

 

In addition to the products mentioned in the warning letter, the FDA recently issued a warning about another product sold through the Amazon platform.

 

This product is sold by a US seller. After inspection, the FDA found that this product contains diclofenac and dexamethasone, two powerful anti-inflammatory drugs. The FDA reminds consumers who have purchased this product to stop using it immediately and consult medical professionals in a timely manner for comprehensive health guidance.

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