Is Provitalize FDA approved?

For many women in the throes of menopause, Provitalize has provided some much-needed relief. There are thousands of glowing reviews for Provitalize from people who have found it made a difference when nothing else did.

At the same time, Provitalize isn’t without its fair share of skepticism. There are many menopause relief products on the market, and consumers want to know why this one is a cut above the rest: What does Provitalize do for your body? Is Provitalize FDA approved? Does Provitalize work? These are all valid questions, and we’ve got answers.

The Basics Behind Provitalize

First thing’s first: What is Provitalize? It’s a dietary supplement available over the counter (OTC). Though anyone can take Provitalize and no prescription is required, it was specifically designed for women reaching or going through menopause.

The Provitalize ingredients list can help shed some light on what the formula entails. At its core, Provitalize is a probiotic supplement. It contains three unique strains of probiotics, plus prebiotics to further encourage a diverse gut microbiome. However, it’s not just a probiotic. Provitalize also contains plant extracts and other ingredients, such as turmeric and moringa. Each ingredient was carefully chosen based on the available research as it relates to gut health, inflammation, and more.

All of this might sound nice, but in actuality, what does Provitalize do for your body? Provitalize benefits can differ from person to person, but its purpose is to support gut function, which is often at the root of menopause symptoms like bloating and weight gain. Your gut can influence your overall well-being, including body weight, inflammation, immunity, sleep issues, and more, research has demonstrated.

What Does FDA Approval Mean?

Is Provitalize FDA approved? Before we get into it, let’s recap what FDA approval entails. Keep in mind that Provitalize is a supplement, not a drug—the two are regulated differently. Here’s how it works.

How FDA Approval Works for Drugs

FDA approval refers to the U.S. Food and Drug Administration and its determination of whether something is suitable for public health. Its job is to ensure the safety and efficacy of a variety of products—not just supplements but also food, cosmetics, drugs, and so on.

Since these various products have stark differences, they’re regulated differently. Drugs have some of the most stringent processes before they can come to market. In order to earn FDA approval, a drug must undergo a slew of testing—not just in the context of safety but also to ensure it works as intended. As explained by the FDA, drug approval usually begins with laboratory and animal testing. Then it’s tested on humans in clinical trials. Through these tests and trials, scientists collect all sorts of data on its risks and benefits, which is then analyzed by the FDA.

If this seems like a lengthy process, that’s because it is. Years of research go into bringing new drugs to the market, so it can take a decade or longer, though it can be accelerated in some cases.

How FDA Regulates Supplements

Now that you know how drugs are approved by the FDA, what about supplements? It’s a totally different process but one that’s important to understand if you use any supplements in your routine.

According to official FDA updates, U.S. laws stipulate the following:

1. The FDA doesn’t have the authority to approve dietary supplements for safety and effectiveness before they’re sold to the public.

2. It’s the responsibility of supplement companies—not the FDA—to ensure their products meet safety standards and aren’t in any violations.

3. Companies must identify their products as supplements and provide a Supplement Facts label with the appropriate information.

Finally, supplements can’t claim to prevent or treat a disease as doing so would liken it to a drug.

Is Provitalize FDA Approved?

FDA approval only applies to drugs—not supplements like Provitalize. However, that doesn’t mean that the FDA is completely out of the picture. Essentially, the FDA creates regulations, and supplement companies must follow them.

The Short Answer

Is Provitalize FDA approved? In short: No, Provitalize isn’t FDA approved. This is because Provitalize is an OTC dietary supplement, not a drug. As we’ve discussed, drugs require years of research and testing as well as FDA approval before they can come to market. While supplements must be safe and effective, it’s up to supplement companies themselves to ensure this. 

Is FDA Approval the End All, Be All of Supplements?

By now, you’ve learned that Provitalize isn’t approved by the FDA, which is in line with how supplements are regulated. You’ve also learned that supplements can’t claim to treat or prevent any diseases.

So if this supplement doesn’t treat menopause—as that would constitute it as a drug—what does Provitalize do for your body? Menopause comes with a medley of challenges, but isn’t a disease and there isn’t a cure for it. Provitalize doesn’t claim to eliminate menopause symptoms, though the ingredients can certainly be beneficial for some.

Like the FDA says, BB Company is responsible for making sure that Provitalize is safe and effective. We do that by adhering to the safety standards for dietary supplements and ensuring that there are no violations of the law. 

What We’ve Done to Ensure Provitalize Works Safely

With all this in mind, you might be wondering—is Provitalize safe? Here’s a closer look at the measures we’ve taken.

Manufacturing Standards You Can Trust

Is Provitalize FDA approved? No, but that doesn’t mean there aren’t quality standards in place. To minimize Provitalize side effects and ensure safety and efficacy, BB Company does the following:

• Manufactures in accordance with safety standards for dietary supplements. 

• Labels each bottle with Supplement Facts, including serving size, number of servings per container, a listing of all ingredients, and the amount of those ingredients per serving.

• Uses facilities in the United States that follow Current Good Manufacturing Practice (cGMP) and are certified as such.

• Partners with Eurofins laboratories for comprehensive third-party testing.

• Formulates with ingredients that are backed by research and years of traditional use.

The FDA may not have the authority to ensure our products are safe, but we do. It’s a responsibility we take very seriously from ingredient selection to bottle labeling and everything in-between.

Ingredient Transparency and Continuous Improvement

Still wondering, “What does Provitalize do for your body?” It all comes back to the ingredients, which are as follows:

• L. Gasseri SBT2055, B.Breve IDCC04401, and B.Lactis R101-8 probiotic strains

• Fructooligosaccharides (FOS) prebiotics

• Turmeric root extract

• Moringa leaf extract

• Curry leaf

• Sunflower lecithin

• BioPerine (aka black pepper)

Ingredient transparency is an important part of ensuring Provitalize aligns with FDA standards for supplements. Even if the FDA didn’t mandate Supplement Facts labels, we’d still disclose how Provitalize is formulated because we’re proud of it. The ingredients are simple and many of them have been used for thousands of years. 

Customer Support for Peace of Mind

Should you have any additional questions or concerns, we’re here to help. BB Company offers 24/7 customer support via virtual agent. You can also visit our Contact page for more ways to get in touch, such as email or phone.

What’s more, we offer a 90-day money-back guarantee for non-autoship orders. This doesn’t apply to ongoing subscriptions, so if you’re a new customer, we recommend choosing the “Buy Once” option at checkout. Once you’ve given Provitalize a try, you can consider switching to regular autoships for convenience and savings.

Take the Next Step in Your Menopause Journey Today

Reading Provitalize reviews and taking the time to understand our safety measures can give you some reassurance. Still, it’s normal to have questions.Is Provitalize FDA approved? What does Provitalize do for your body? What’s the catch?

While Provitalize isn’t FDA approved, this is customary for supplements. Provitalize is manufactured according to safety standards for supplements, including Supplement Facts labeling, using cGMP-certified facilities, and more. It’s not a drug, so Provitalize doesn’t require FDA approval. Even so, we’re transparent about our ingredients and manufacturing, and we’re constantly striving to improve.

We’ve taken precautions to make sure Provitalize is safe for most people, but if you have any lingering concerns, it’s always a good idea to consult a trusted healthcare professional. You just might discover that Provitalize is a mainstay on your journey.