I cannot find the registration record for Aiwo cup. I’ve searched using all of the names I know for the cup. I recognize the difference between a recommendation, and a requirement for a silicone to qualify as medical grade, and that these products are not rigorously tested by the FDA. However it is nice to know that ‘pacifier safe’ is not the only metric in safety met for this product, and that it does qualify as ‘meeting the same purpose, and standards as similar products on the market’.
You probably already researched some of this so I apologize in advance.
It can be hard to find a registration for a cup on the FDA list if the company or manufacturer doesn’t register a cup under a specific name. You might have noticed that there are many listings for “menstrual cup”.
In my eyes, this is a loophole to getting away with not paying a fee for every item.
A manufacturer can produce a generic cup, submit all the needed paperwork, and then sell a number of cups and designs under that registration. They can also wholesale those items to be purchased under a private label as the Aneer & iCare Cups do. If you look at one of their listings on Alibaba and/or Aliexpress, you can see that they offer to customize your “brand” on bags, boxes, and pamphlets. Still, they would not register a “brand” name but keep a generic, “menstrual cup” as their registered item.
Don’t rely 100% on the FDA list. They only require paperwork to basically say, “our item works like the Diva Cup and works just as well” and pay a fee. The intended purpose is that if any recall needs to be made, the FDA has someone to contact. The actual product doesn’t even have to be reviewed by the FDA. Plus, there is no guarantee that the company/manufacturer that carries the registration is using the material that is stated on the paperwork. It’s cheaper to pay the $4000 + fee and then use cheap or altered material and hope that you don’t get caught. Chances are, the mass of people who use the item will not make a report if there is a problem. Many reports to the FDA about a particular item are needed for any recall action to take place.
If a company doesn’t have a hand in the manufacturing process then I would take any information that they give about it, with a grain of salt. They can only pass on information they were given by their manufacturer. Even then, who’s to say that the manufacturer has followed all manufacturing guidelines 100%. One example is that a process, such as curing time, can be shortened or skipped altogether without the buyer knowing. Shortening or skipping this process can leave volatiles in silicone but can go undetected to the eye.
The best advice I can give you is to go with your gut and with a reputable brand. You may also want to pay attention to what they are registered as.
Manufacturer – makers of items/products/devices.
Specification Developer – sells a product under its own name but does no manufacturing.
Contract Manufacturer – manufactures a product for others to sell
Foreign Exporter – people who manufactured, prepared, processed a product in a foreign country to be sold in the U.S.
Repackager/Relabeler – a person who repacks and relabels a product to sell.
Food-grade silicone items like pacifiers, bottle nipples, bakeware, utensils, and such, are only separated from medical-grade silicone by a biocompatibility test. All medical-grade items were once food-grade. Some swear that food-grade is perfectly fine to use as a menstrual cup, while others rather have the added peace of mind that no toxicities can be leached into the body. You may notice that most, if not all, listings on Alibaba & Aliexpress now state that their item is made with FDA “approved” silicone or that it’s made of medical-grade silicone. Many used to say ‘food-grade’. They even include scans of certificates. However, just like many photos on the internet today, they are easily photoshopped.
One of the things I like to check before purchasing an item is to look at customer service. Do the sellers care about their customers or are they just out to make a buck? Do they take any time to reply or answer questions? Ask groups or forums for their experience or options.
I apologize for this wall of text. It’s probably a lot more than what you were asking for, but I want people to have the information to make a decision that’s right for them.
I don’t suggest anyone use a “cheapie” cup but some individuals are totally content with the risks. It’s my two cents, but it’s their body, their choice.
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