Customers often ask us if Pixie Cup is FDA Approved. In this post, we’ll chat about the ins and outs including what FDA Approval actually means.
The Food and Drug Administration is responsible for telling us which foods, drugs, and medical devices are safe for us to use. And while we assume that anything that’s been cleared or approved by the FDA has been rigorously tested, that’s not always true. We value transparency and want to debunk myths by outlining everything between the FDA and menstrual cups!
What is FDA Approval?
FDA Approval happens (or doesn’t happen) when a company registers their product with the FDA. A mountain of paperwork is submitted, and the FDA conducts rigorous inspections of concept, manufacturing, ingredients, and materials.
“FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval.
What does the FDA regulate?
For the most part, the Food and Drug Administration evaluates the safety of:
Dietary supplements (not all are subject to FDA regulation)
Medical devices (everything from menstrual cups to pacemakers)
Products that give off radiation (e.g. X-rays, microwave ovens)
What about menstrual cups?
The FDA allows companies to piggyback off other concepts if they can prove their product does the same job as a competitor and that the manufacturing, packaging, and ingredients are FDA Approved; this is called FDA Cleared. [or 501(k)] Menstrual cups are considered a Class II medical device, meaning it is inserted into the body but doesn’t aid or perform surgery or sustain life.
FACT: No menstrual cup on the market has been officially FDA Approved.
Most of them are officially FDA Cleared, however. Let’s take a quick look at how the Food & Drug Administration regulates tampons, pads, and menstrual products in general.
As the rise for health and wellness continues in recent years, women are seeking out more information about what exactly goes into our bodies. (yay for us!) And with that, we’ve started to question what’s in tampons and pads. An article in the New York Times hits the topic hard. Because up to this point, the FDA doesn’t require manufacturers to put ingredients on the packaging of disposable menstrual products. There is currently a bill in legislation about transparency in tampons + pad ingredients.
If you’re curious as to what’s actually been found in mainstream tampons and pads, our friends at MadeSafe have put together all the specifics.
Is Pixie Cup FDA Approved?
We have gone above and beyond to make sure our manufacturers maintain a level of safety and excellence. They undergo annual unannounced inspection and audit to ensure quality and safety standards are still in place. We, at Pixie Cup, are the specification developers and have to complete the application process to be FDA Cleared for sale in the USA. Our manufactures and packagers also have to be FDA Approved. The approval process for them is more rigorous as their facilities have to maintain FDA standards.
Here at Pixie Cup, we only use medical-grade silicone. Medical grade silicone is approved by the FDA for its biocompatibility, which means it’s safe to be inserted inside the body without any risks. So while the cup itself may not be FDA Approved, the material we use is. The medical-grade silicone that we use for our Pixie Cups is hypoallergenic and latex-free, so it’s safe for people with latex allergies. Silicone is also non-porous, which means that it’s resistant to bacterial growth. That being said, it’s still extremely important to make sure that you keep your cup as clean as possible and wash it every time you use it.
When using your menstrual cup regularly, be sure to maintain cleanliness and sterilize your cup appropriately and regularly so it’s the best condition possible! If you’re new to using a menstrual cup, you will soon realize all the benefits and freedom that comes along with them!
We’re in this together.
Here at Pixie Cup, everything we do is geared towards making an impact for the better. Every time someone purchases a Pixie Cup, we donate one to a woman in need through our Buy One, Give One program.
On top of that, we care about YOU too! We care about your satisfaction and that’s why we have our 100% Happiness Guarantee. If for any reason you aren’t totally thrilled with your PIxie Cup purchase, we will refund you. Along with that is our transparency — please feel free to contact us regarding any questions you may have. We’re here to help!
Many women are switching to menstrual cups because not only are they better for the environment, but also for health + wellbeing! Continue reading to learn more about the revolutionary period care and the benefits of using a menstrual cup.
What is a menstrual cup?
Aren’t sure what a menstrual cup is? It’s a flexible cup designed for use inside the vagina during your period to collect menstrual blood. The cup actually collects the menstrual flow rather than absorbing it as tampons or pads do. Menstrual cups are commonly made of 100% medical grade silicone. They’re flexible and easy to care for.
How do I use a menstrual cup?
If you’ve used tampons for years, you’ll likely be able to adjust to a menstrual cup with ease. For the pad-only users, it may take a little getting used to but you’ll get the hang of it! Here are some simple instructions:
First off, wash your hands well.
We suggest applying a water-based lubricant (like our Pixie Cup Lube) to help make insertion easy and comfortable. Apply the lubricant to the rim of the cup.
Insert the cup, rim up, into your vagina like you would a tampon but without the applicator. It should sit a few inches below your cervix.
Once the cup is in your vagina, grab the stem and rotate it. This will help it spring open to create an airtight seal that stops your cup from leaking.
What are the health benefits of using a menstrual cup?
We’ve recently discussed how tampons can contribute to vaginal dryness. When your vagina is dryer than usual, it can become a breeding ground for bacterial overgrowth, which may disturb the delicate pH and bacterial balance in your vagina. Ultimately this could lead to an infection. Your menstrual cup doesn’t disturb your natural fluids and flora in the vagina and does not soak up anything.
Tampons are linked to Toxic Shock Syndrome (TSS), which happens when a substance is in the body for too long. A menstrual cup holds menses in the silicone cup as opposed to having it continually touch the vaginal walls. Our friend, Meg, gives a great explanation of TSS in her YouTube video.
Menstrual cups are eco-friendly!
This is a pretty hot topic regarding the benefits of a menstrual cup these days! The average woman uses 5 tampons a day during her period. That combined with the number of days in your period, multiplied by the number of years the typical woman menstruates equals thousands of tampons or pads in the landfill. Ack!
Menstrual cups can last up to 10 years if properly taken care of! That means that 1 single menstrual cup can save up to 3,500 tampons/pads being sent to landfills. That number really puts it into perspective, huh? And when the menstrual cup’s life has come to an end, all you have to do is throw it into your wood stove or have a ceremonial burning at the next bonfire. It burns to simple ash that is completely biodegradable.
How convenient are menstrual cups?
Girl, pull up a chair! A tampon holds 5ml of fluid when it’s completely maxed out. Our Pixie Cups come in three sizes. Here is a great visual:
Small – holds 25ml | Large – holds 30ml | XL – holds 35ml
That means you can literally go hours between changes. It depends on your flow, but technically you can safely go 12 hours before you empty your menstrual cup.
Hot yoga class? Go sweat it out.
Are you training for a marathon? This period protection has your back.
Spending the day at the beach? Pack the sunscreen, but don’t pay any attention to Aunt Flo!
On a budget? Another benefit of a menstrual cup is it’s a purchase you make once a decade. No more last-minute runs to the gas station convenience store or sending your boyfriend to buy your pads. It’s one less thing you have to scramble cash for every month.
One of the things most women hate during their periods is how “dirty” or “gross” they feel. Not only are your hormones raging and you’re potentially bloated, but you smell. Even if no one else can pick up an odor, you can. And that’s honestly what matters most: YOU BEING CONFIDENT. Because a menstrual cup holds your menses completely airtight in the vagina, there is no odor that comes sneaking out. If you have an issue with your menstrual cup leaking, we have some tips and tricks to help with that.
No more surprises!
If you are tracking your period regularly, via an app on your phone or by bullet journaling, you probably have a really good idea of when your period is going to arrive. Gone are the days of hyper-packing your purse or backpack just in case your period surprises you. If you use a period cup, you can place it in the morning and go about your day — if Aunt Flo visits, you’re already prepared for her!
IUDs (Intrauterine Device) are all the rage as they are promoted as the “set it and forget it” birth control. Depending on which type you choose, an IUD can be effective for 5-10 years. For anyone who has taken a birth control pill every day for years, this may sound like the best thing since sliced bread! With the rise of IUD usage and the popularity of period freedom with a menstrual cup, women are questioning the safety of menstrual cups with an IUD.
What is an IUD?
As mentioned, an IUD is a device that is placed inside the uterus, just past the cervix. It is comprised of a T-shaped piece of plastic (or metal) with strings attached to the base. Very similar to fishing line, the strings are used later down the road when you want your IUD removed. A quick tug and it’s out!
Depending on the IUD you choose, it may contain synthetic hormones that are slowly released over a long period of time. There is also a copper IUD that is hormone-free. That one relies mostly on the molecular structure of copper and how it and sperm don’t get along. The general shape of IUDs discourage the movement of sperm also.
First, to put the IUD in, the nurse or doctor will put a speculum into your vagina. They’ll then use a special instrument to insert the IUD through the opening of your cervix and into your uterus. The process usually takes less than five minutes.
TIP: You may want to request the insertion be during your period. Having the insertion of the IUD during your menstrual cycle may help ease discomfort. During menstruation, your cervix is already opened to a degree.
What is a menstrual cup?
A menstrual cup is a reusable silicone menstrual product that holds menses in the vagina and can be worn for up to 12 hours. The shape is similar to that of an eggshell and can hold several tampons’ worth of fluid. Here at Pixie Cup we have several shapes and sizes to match your specific body and specific needs!
Can I use a menstrual cup with an IUD?
This question is hitting Google hard these days! The short answer is YES! There are some things to consider and keep in mind during the process. However, the good news is you definitely can.
Strings strings strings. When you get the IUD inserted, the provider will avidly tell you to check your strings on a regular basis. Especially within the first three months of insertion. If you mention the fact that you use a menstrual cup, the provider can try clipping the strings as short as possible. If you’re an IUD pioneer, chances are it’s been placed for quite some time already. You’ll want to try to “scoop” the strings up when inserting your cup so they sit inside the menstrual cup.
Get to know your cervix. Did you know that your cervix moves throughout the month depending on where you are in your cycle? As a general rule, your menstrual cup is designed to sit in the vaginal canal vs up against the cervix. However, for anyone with a tipped or tilted uterus, your cervix is generally lower in your canal. Measuring your cervix is a great idea when choosing what menstrual cup to use. Especially in relation to where your IUD is going to be hanging out!
For any gal with a tipped or tilted uterus, we’ve got you covered! We made the Pixie Cup Slim just for you! This slim design is made to sit just inside the vaginal opening, away from your cervix.
Break the seal. As a general rule, we recommend breaking the seal no matter what when removing your menstrual cup. It makes it easier and quicker versus tugging on something with a pretty good suction going on! To prevent the IUD from moving at all, be sure to break the seal. Do this by sticking your finger up the side of your menstrual cup to create the ‘C’ shape. Gently pull down and out!
Can a menstrual cup dislodge my IUD?
Expulsion (your IUD falling out) is most likely to happen in the first three months, according to sources. During this time, your body is getting used to this foreign object that’s suddenly taken up residence with its hormones! Some women have reported that their body “rejected” the IUD. Much like an annoying splinter, their body pushed it out! In other cases, incorrect placement leads to expulsion. Be sure to choose a healthcare provider who regularly inserts IUDs as this will ensure both comfort and proper placement.
The good news is that research has shown that there is no increased risk of IUD expulsion with the use of menstrual cups. (Yay!)
Have you thought about using your menstrual cup with your IUD? Do you have a tilted uterus? Be sure to check out our online store for more information about your Pixie Cup Slim! Talk to us — we love to hear from you!
PLEASE NOTE: This blog post is not intended as a substitute for the medical advice of your doctor. You should regularly consult a physician in matters relating to your health. Particularly with respect to anything related to menstruation. If you have any concerns about using a Pixie Cup, consult your doctor before use. If you have any gynecological conditions, please talk to your physician before using any menstrual cup.
The first key to menstrual cup success is making sure it’s cleaned properly. Sterilizing your menstrual cup before the first use in your cycle and right before you store it for the month is crucial. However, quickly washing your menstrual cup with soap before reinserting is perfect.
How do I wash my menstrual cup?
Ideally, washing your menstrual cup with a synthetic oil-free, unscented, gentle soap is best. Silicone is a substance that withstands tremendous levels of heat, but chemically we have to be mindful of what we use on it. Secondly, we have to be careful of anything that residually could be put into our vagina. Our lady region has a perfect balance — soaps, perfumes and synthetics can severely throw off our pH level, which could result in an infection of its own!
Our Pixie Cup Wash is formulated with your menstrual cup and our va-jay-jay in mind! We have 13 all-natural ingredients that make up our Pixie Cup Wash. No crazy ingredients here — only things that are safe, work and that you can pronounce 😉
Here are our super-safe Pixie Cup Wash ingredients:
Distilled water is water that has been filtered to remove minerals.
Phellodendron (amur cork tree) extract
Fructus Cnidii extract
Radix Stemonae Extract
So now that we’ve talked about ideal soaps and ingredients, let’s talk about what NOT to use when cleaning your menstrual cup!
As tempting as it is to grab your mainstream lady wash from the shower, it’s definitely not a good idea. Just don’t do it. Believe it or not, they are designed to only stay on the outside of your body! (Doctors are starting to speak against them too) Where a menstrual cup is an internal object, it’s best to make sure there is no perfume or residue that could be deposited and cause irritation or infection.
What about Toxic Shock Syndrome? (TSS)
Leaving your menstrual cup uncleaned could lead to infection, which is a rabbit hole that’s not fun. Toxic Shock Syndrome (TSS) is something that is typically associated with tampons. That being said, if a menstrual cup isn’t cleaned completely, it can carry bacteria as well! Meg does a fantastic job of describing what exactly TSS is and how it pertains to you, a tampon and a menstrual cup.
How should I store my menstrual cup?
Be sure to boil or steam your menstrual cup to sterilize it after your cycle as finished before you put it away for the month. Make sure that you are keeping it in a breathable bag so it doesn’t keep moisture and aid bacteria growth — Steer clear of plastic or airtight containers!
Now… how about keeping a bottle of our Pixie Cup Wash on hand so you’re never without a perfect + safe option?
Sterilizing your menstrual cup is key to extending the life of your cup as well as making it safe to use. One of the best features of a menstrual cup is that it can safely be worn for up to 12 hours (this does depend on your flow as well.) With this in mind, a quick wash during the day is just fine… remember, we’re shooting for a low-stress, low maintenance period!
With all the buzz about BPA and the rise of different reusable materials, it’s important to know what touches your body and what you put in it. Menstrual cups are made from medical-grade silicone. This has taken the worry out of using it inside our bodies and is super easy to keep clean! Here are all the how-to’s!
How do I clean my menstrual cup for the first time?
Yay! Your new menstrual cup arrives. You’re nervous and excited. It’s like a blind date. But messier. You’ve opened it, now what? Boil it! Boiling for approximately 5 minutes is a simple way to ensure your cup is completely clean and ready for use! Make sure your pot has enough water so the menstrual cup is able to float around.
Life hack: squeeze your cup into a whisk and submerge in the water. This protects your cup from harsh contact with the bottom of the pan, which could damage it.
Picking a wash that’s formulated both for the safety of your cup and for you is best. Check out our Pixie Cup Wash for a gentle option! The foamy soap is made from plant-based ingredients and is designed to not harm the vagina or pH levels. If our Pixie Cup Wash isn’t available to you at the moment, make sure you pick something that doesn’t contain dye, oils or harsh chemicals. Fragrances are also a no-no for our lady region!
Rinse with warm water and apply cleanser. Rub around between fingers until yucky residue is gone.
Fill the cup with water and cleanser, place your palm over the top to create a seal and SQUEEZE! This forces water and soap to exit through the suction holes around the top. If stubborn stuff is still in the holes, dip a toothpick in rubbing alcohol and gently poke.
Keep your Pixie Cup Wash in the shower! Empty and clean your cup in there to keep the mess contained!
Cleaning your menstrual cup with soap and water every time you empty your cup is just fine. However, when you’re wanting to put it away for the month or pulling it out to use, you need to sterilize. When done properly, sterilizing eliminates all bacteria so nothing continues to grow.
Medical-grade silicone is quite cool. It’s gentle on us, yet rugged enough to have little staining and is heat resistant up to 500 degrees Fahrenheit. Boiling your cup is the most common way of sterilizing. If you don’t have a stovetop available to you, our Pixie Cup Sterilizing Container makes microwaving your menstrual cup super easy! Fill ¾ with water, place your menstrual cup inside and place the lid on top, but don’t snap it on completely. Leave a space so air can vent through safely.
Do you have roommates? Are you going to visit relatives soon? Or maybe you’re not keen on using the same kitchen items to boil the menstrual cup that you use to cook with! We hear you! The Pixie Cup Steamer is a quick 3-minute fix for sterilizing and can be done while you’re finishing getting ready or pouring yourself a coffee. It only takes a few inches of space on your bathroom counter or bedroom dresser. Be sure to follow the included directions to safely steam your cup. This is a great way to sterilize your menstrual cup without boiling.
How do I clean my menstrual cup in public?
Keep in mind, your Pixie Cup is designed to stay put for up to 12 hours, but life happens and we all find ourselves in less-than-desirable circumstances! Our favorite option for this is our Pixie Cup Wipes. Don’t carry a purse? These packets are slim so you can slip one in your wallet or clutch no problem! Our wipes are biodegradable and flushable so you can flush and go.
What about menstrual cup stains and odor?
Sometimes no matter what we do, there is a lingering odor. Makes sense, right? Your menstrual cup has a dirty job! Making a quick odor-eliminating rinse with items you typically have in the house is an easy fix.
Stains happen everywhere — on our favorite shirts, shoes, bags and you guessed it: our menstrual cups. Getting rid of stains is possible! We also shouldn’t underestimate the power of the sun that we have every day. Set your cup directly in the sun for the day and give it a good sun-soaking before you put it away in the dark for a month!
When do I need to replace my menstrual cup?
A menstrual cup is safe to use for up to 5+ years… technically. That being said, the care and keeping of your cup plays a heavy role. Make sure you’re sterilizing regularly and using the correct type of soap on your cup to prevent drying and cracking. If you notice any sort of cracking in your cup or the outside has become tacky to the touch, discard immediately. At this point, the silicone has been damaged and shouldn’t be used any longer. The most eco-friendly way of disposing of your menstrual cup is to burn it, believe it or not! Toss it into the woodstove or the next bonfire. It doesn’t produce toxic fumes and burns to a simple ash!
Our Pixie Cup Steamer takes the worry and work out of sterilizing your menstrual cup! Add water, place your cup, put on the lid + click the button. Now, put on some mascara and throw your hair in a top knot — go rock your day!
Are you about to head out on vacation? Gearing up for a surf? For any of our southern hemisphere gal pals, you’re in the height of your warm weather and you’re looking for options regarding swimming on your period. You’ve come to the right place!
Pads, tampons, or menstrual cups… oh my! If you live an active lifestyle at all, pads just don’t cut it anymore. Thank goodness for modern innovation and advances! There is the tried and true tampon, but do you find their freedom only extends so far? Typically, you’re tied to a couple of hours of activity and you need to change it. Have you thought about a menstrual cup?
A menstrual cup is a reusable silicone menstrual product that holds menses in the vagina and can be worn for up to 12 hours. With a menstrual cup, you truly don’t skip a beat; you don’t have to plan your tropical vacation around that dreaded week a month and you don’t have to think twice about a spontaneous dip!
Can you imagine a world where you didn’t dread your period? Where it didn’t put a hiccup in your activities in any way? Would you believe we’ve actually arrived there?
With a menstrual cup, you truly don’t skip a beat; you don’t have to plan your tropical vacation around that dreaded week a month and you don’t have to think twice about a spontaneous dip!
Trying something new, like a Pixie Cup, is always a little scary but we’re here for YOU and we want to answer any questions you might have. So grab your favorite beverage and let’s dive into a Q&A sesh!
Will the menstrual cup slip out with all the extra water around?
Nope! Remember, the Pixie Cup creates a tight seal against all sides of your vaginal wall, so there isn’t any moving it without a good tug! It’s super important to make sure you have the proper size and style cup for your body. Check out how to find the right cup with our guide on how to measure your cervix and other important information!
Won’t I attract sharks or other unfriendly things while swimming on my period?
With the right sized Pixie Cup, you don’t have leaks and therefore no one is the wiser! Including those sharks 😉 Here is a handy dandy guide to eliminating leaks forever!
How long can I be in the water before I need to head to shore to empty it?
Girl, you got this! If I know that I’m going to be busy in an activity for an extended period of time, I always make sure to empty my cup prior to gearing up. Remember, if you have the right sized cup for your flow, you can wear a Pixie Cup for up to 12 hours without having hitch! It’s truly a set-it-and-forget-it solution for your active life!
Ok so, what if I have to pee in the ocean… can I do that with my Pixie Cup?
Hey, when you gotta go, you gotta go! Believe it or not, if a Pixie Cup is properly placed, it doesn’t inhibit urination at all! We definitely recommend testing your fit and placement out at home prior to putting it to the true test out on the waters.
Swimming on your period has never been easier and swimming with your menstrual cup has never been better — Pixie Cup has your back!