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Our manufacturer is also ISO9001 Certified. Learn More Here >
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So What Does This Mean?
All types of heat and cold packs are considered "Medical Devices" by the Food & Drug Administration (FDA). As crazy as this sounds, here's the proof: FDA Hot & Cold Pack Classification As A Medical Device Information >
The FDA requires BOTH sellers (like us and our competitors) and manufacturers to register annually with the FDA and pay $1,000's of dollars to do so. The parent company of Snappy Heat brand has an active registration with the FDA, all protocols and compliance requirements are updated with the FDA on an annual basis.
Our manufacture is also registered with the FDA, but registered as a manufacturer of these "medical devices" - a slightly different registration type, but still required by the FDA for all manufacturers of heat and cold packs, regardless of the country of origin (all foreign and domestic manufacturers must have an FDA registered facility).
The FDA requires BOTH sellers (like us and our competitors) and manufacturers to register annually with the FDA and pay $1,000's of dollars to do so. The parent company of Snappy Heat brand has an active registration with the FDA, all protocols and compliance requirements are updated with the FDA on an annual basis.
Our manufacture is also registered with the FDA, but registered as a manufacturer of these "medical devices" - a slightly different registration type, but still required by the FDA for all manufacturers of heat and cold packs, regardless of the country of origin (all foreign and domestic manufacturers must have an FDA registered facility).
Why Do They Do This?
The FDA is a governing body designed to track, monitor and oversee all Medical devices manufactured, distributed and sold in the US. They're here as a consumer protection agency, to ensure safe products reach the market and to weed out any potential harmful items.
Do All Heat Pack Sellers Have A Registration?
Unfortunately, most do not. Only those following Federal Law have the required registration. There are many sellers on Amazon, eBay and other eCommerce platforms that simply don't care about safety and compliance. Registration and compliance is expensive, and some sellers without the required registration are gambling with your health and potentially harmful products, in exchange for bigger profits.
Does Amazon Require An FDA Registration?
No, Amazon does not enforce Federal law. If your supplier on Amazon, eBay or any other eCommerce platform does not have an FDA registration, proceed with extreme caution. If something goes wrong with the product, you'll have little or no recourse against the seller / manufacturer and there's no telling what the item is made out of. No sellers are exempt from this law regardless of the product's "intended use". Example: a seller of heat packs claims the pack is "recreational use only" or is selling it as a "novelty", in the eyes of the FDA, it's STILL a medical device.
Do All Heat Pack Sellers Have A Registration?
Unfortunately, most do not. Only those following Federal Law have the required registration. There are many sellers on Amazon, eBay and other eCommerce platforms that simply don't care about safety and compliance. Registration and compliance is expensive, and some sellers without the required registration are gambling with your health and potentially harmful products, in exchange for bigger profits.
Does Amazon Require An FDA Registration?
No, Amazon does not enforce Federal law. If your supplier on Amazon, eBay or any other eCommerce platform does not have an FDA registration, proceed with extreme caution. If something goes wrong with the product, you'll have little or no recourse against the seller / manufacturer and there's no telling what the item is made out of. No sellers are exempt from this law regardless of the product's "intended use". Example: a seller of heat packs claims the pack is "recreational use only" or is selling it as a "novelty", in the eyes of the FDA, it's STILL a medical device.
