Warning! Amazon Sells Products From China that Might Not Be Complying with FDA Rules

  • Certain Amazon's cChoice products have a strong chemical smell.
  • It is plausible some of the products from China are not compliant with FDA standards.
  • Many products from China have dangerous chemicals in them.

These days online shopping has become part of many regular shopping habits in many households around the globe. It is supposed to simplify and save time compounded with convenience. With the emerging of the virtual assistants like Alexa, it is even easier. Being an Amazon prime member, the convenience of free guaranteed delivery within 48 hours and in some instances 24 hours is an attractive shopping method.

Myself, being a member, I recently ordered Baker Depot 6 Holes silicone mold to use for baking desserts.

The item as you can see (above) is Amazon’s Choice and reasonably priced. As per usual, the item arrived within the guaranteed time frame. Upon opening the package, a strong chemical smell filled the area of my kitchen, causing immediate concern.  I have purchased many silicone baking products before but never experienced such a strong odor. After scrolling Amazon for further information on the item and FDA approval, I was not able to locate anything on the Amazon website, but encountered the customer reviews with complaints about the chemical smell, which continued to linger. Yet, the item had many positive reviews as well.  The plastic packaging came with a pamphlet regarding the product and its use.

Noticeably, the pamphlet has very different use of the English language and it can easily be assumed that it was translated into English from Mandarin. It states the item comes directly from China and it is FDA Food quality. A pamphlet boasts the items are being sold on Amazon, AliExpress, Alibaba and eBay.

During a search of Google and AliExpress.ru, the certificate was found of the  FDA standard testing, which was completed in Chinese facility in 2012.  The certificate states that the silicone is in compliance with FDA CFR 21 177.2600.

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. As per the FDA website, it’s mission is to be responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. For consumers, it gives a peace of mind to trust the product and its safety, as FDA has a very rigorous process and standards in regards to the quality of products.

To expand, the FDA has specific regulations in place on the three different types of food additives: direct, secondary direct, and indirect.

  1. Direct food additives that are added to the food and an example could be food coloring.
  2. Secondary direct food additives are the ones that are added during the treatment process. Hence, they are the additives needed during the manufacturing process and removed from the final product.
  3. Indirect food additives are components that have a possible chance of coming into contact with food but are not intended to be added directly to food.

What is FDA CFR 21 177.266? 

It is the standard that is applicable to the indirect food additives, especially relating to the rubber and rubber products (rubber articles intended for the repeat use definition)

The list of allowed indirect additives includes vulcanization materials, elastomers, accelarators, activators, antioxidants, plasticizers, emulsifiers, and fillers. A purpose of the list is to allow materials which are considered safe under GRAS (Generally recognized as safe); The United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.

FDA 21 CFR 177.2600 has a provision stating that the rubber products intended for repeated use in contact with food should be thoroughly cleansed prior to their first contact with food. Approved substances include acrylonitrile-butadiene copolymer (Buna), silicone, polytetrafluoroethylene, and ethylene propylene diene monomer. With this explanation now one can understand what USP Class VI means on the product means.

So what could be the cause of the strong chemical smell? There are many plausible explanations. Some claim it is due to the products being left in airtight packaging for a long time. Therefore, the volatile molecules build up, resulting in the smell concentration. When opening the package, the immediate release of these molecules allows for the strong smell immediately to be noticed. A campaign started in 2005 to ban “smelly plastic products from China.”  However, it did not get the traction it needed.

Additionally, there is a poplar google search “Made in China Smell” and you’ll get over 28 million results.

Getting back to the silicone baking mold, the strong chemical smell could be actually dangerous to human health, after prolonged use. It can be an indicator of other chemicals used.  Normally, silicone products that are made from FDA approved food grade silicone do not have a strong smell. Therefore, the conclusion could be the silicone used in this product could have certain chemical additives that might not comply with the FDA 21 CFR 177.2600. The additives that are commonly added in China-made silicone bakeware are:  BHT, a carcinogen and DEHP and DBP phthalates, which are endocrine disruptors. DEHP is also a probable carcinogen. These carcinogens build up in the human body and can cause cancer.

The FDA opened an office in China in 2008, to aide Chinese manufactures in complying with US standards for their exported products. Nevertheless, even though the FDA does a great job to make sure of the product safety, it does not mean Chinese manufacturers do. Even, if the testing was successful in 2012 (claimed by Baker Depot), it does not mean now it is compliant. It is plausible that more dangerous chemicals were added to offset costs and to increase profit margins.

I contacted Amazon and spoke to their management team. At this time, none had knowledge or were aware of the FDA testing certificate and compliance or more recent reviews. They did show concern. As I pointed out, even in the Amazon comments section of the product, the complaints continue to occur about the chemical smell. I was assured the issues I raised will be escalated, but at this time the product continues to be sold, without any warning or at least proper verbatim of the product origin, etc.  Baker Depot has a whole line of products available on Amazon.

The question remains, how much due diligence does a conglomerate like Amazon conduct for their customers and how does a product such as this end up in the Amazon’s Choice product category? As with the Prime Choice label, it allows the product to be promoted and be on top of the list during the buyer’s search for the item in a specific category. The Amazon marketplace does not state that the product directly comes from a Chinese manufacturer without any US subsidiaries. It is misleading for many consumers, including myself.

Lastly, should there be a standard Amazon is held to and responsible for? The accountability should be there, especially when it comes to Amazon’s Choice or is it just paid marketing on their site and zero responsibility, if the product in fact might not comply with the FDA 21 CFR 177. 2600 standard?

In conclusion, please do additional research before purchasing any products that can have negative ramifications to your health and be aware, Amazon is just another large marketplace that does not guarantee the quality of the products on their website.

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Christina Kitova

I spent most of my professional life in finance, insurance risk management litigation.

2 thoughts to “Warning! Amazon Sells Products From China that Might Not Be Complying with FDA Rules”

  1. This is really great info Christina. You are correct that Amazon is not looking out for their customers. They are gobbling up retail share but consumer safety has been lost in the process. FYI: A large share of reviews on Amazon have been purchased by the seller. Beware.

  2. Thank you for your comments. Yes, I think they should at least have a warning or at least origin, the products ships directly from China, as from that ad you cant see that at all. I got refunded but I would hate to see how many consumers use it and it could be potentially toxic. Plus, it think there should be regulation where FDA US based certificates should be posted, if the items are coming directly from manufacturer.

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