FDA Registration vs. Approval & The Orchyd Menstrual Cup
Menstrual cups cannot be FDA-approved, and this is why you should care.
Yes, the tag “FDA-approved” sounds official and as if it guarantees that your menstrual cup is the safest on the market, but the claim is entirely false.
FDA Registration vs. FDA Approval
The language matters here. When it comes to menstrual cups, understanding the difference between FDA registration and FDA approval is crucial. Menstrual cups are considered medical devices and are monitored by the FDA (the U.S. Food and Drug Administration), which plays a significant role in regulating the safety and efficacy of menstrual cups.
Menstrual cups are classified as class II medical devices, meaning they only require FDA registration. Menstrual cup brands that boldly claim “FDA-approved” are misleading and inaccurate. The FDA expresses that “any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” The fact is, only class III medical devices (think pacemakers, breast implants, defibrillators, cochlear implants, etc.) can be FDA-approved. So, in other words, menstrual cup brands cannot use "FDA-Approved" as a verifiable claim to promote their products.
The Orchyd Menstrual Cup is proudly FDA-registered, which means it complies with safety standards set by the FDA. We do not peddle false claims. Our cup is safe and effective.
Where You Buy Your Cup Matters
Where you buy your menstrual cup can change whether the product is FDA-registered and the overall safety and quality. Many cups purchased from sites like Amazon use false claims to advertise their product. This is an unsafe and unethical practice.
When seeking a menstrual cup, it can be tempting to opt for the quick, cheap option, but by doing so, you risk your safety and the product's reliability. These sites that push unregistered menstrual cups are dangerous. Their products are often counterfeit with below-average safety standards that can pose health risks to the user.
The FDA-registered seal of approval ensures that the manufacturer complies with regulatory requirements, maintains quality control measures, and adheres to safety standards. Menstrual cups that are FDA-registered, like Orchyd, follow the health and safety protocols regulated by the FDA and do not use false messaging. FDA registration guarantees that what you are putting in your body is safe and actually works.
So, be mindful of where you buy your menstrual cup and look for FDA registration. For peace of mind, the FDA-registered Orchyd Menstrual Cup is available on the Orchyd Marketplace whenever you are ready.
The Ingredients in Your Menstrual Cup Matter
The ingredients in menstrual cups also require close inspection and research. The FDA does not regulate the materials and ingredients used to make a product. They only regulate the end product, which in this case, is the menstrual cup, not the silicone used to create it. Therefore, any claim that a menstrual cup is made of FDA-approved silicone is false and should be steered clear of.
Why Medical-Grade Silicone?
Medical-grade silicone is considered one of the safest forms of silicone. It is a hypoallergenic and non-toxic material that is safe for use inside the body. It is also known for its durability, flexibility, and non-reactive properties. Medical-grade menstrual cups, like the Orchyd cup, are latex-free, contain no toxins, cause less irritation or allergies, and are nonporous, meaning they resist bacterial growth.
When choosing a menstrual cup, selecting a cup with no dyes is also important. Dyes are often added to provide color variations, but they may introduce potential risks. Dyed cups can cause allergic reactions or irritations and risk chemicals leaching into the body. Dye-free cups eliminate these hazards.
The Orchyd cup is made of 100% medical-grade silicone and is crystal clear with no dyes so that you can manage your flow safely.
The Orchyd Menstrual Cup Is the Best
Despite claims made by some brands, menstrual cups cannot be FDA-approved. Menstrual cups fall under the category of class II medical devices and are only FDA-registered, not approved. The use of "FDA approved" as a promotional claim is misleading and considered misbranding by the FDA.
The Orchyd cup is FDA registered and adheres to the health and safety protocols that ensure the product's quality and legitimacy. The silicone is 100% medical grade, meaning it is safe, hypoallergenic, latex-free, toxin-free, nonporous, and resistant to bacterial growth. Being dye-free, the Orchyd menstrual cup further guarantees safety for all users.
The Orchyd cup sets the standard for health and safety in menstrual cups. Orchyd doesn’t need to embellish the cup with bold, false statements like FDA-approved silicone or FDA-approved cups. The cup stands on its own as a safe option for all menstruators.