Are Probiotics FDA Approved? What You Need to Know


Are probiotics fda approved

If you’re like most people, you probably think that anything sold in the United States has to be approved by the FDA.

And while that’s mostly true, there are a few exceptions – and probiotics are one of them.

In this blog post, we’ll discuss what probiotics are, why they don’t require FDA approval and some of the things you should look for when choosing a probiotic supplement.

Are probiotics FDA approved?

The simple answer is no – probiotics are not FDA approved. It is not legal for probiotics to be sold as nonprescription drugs unless the FDA has decided that they are safe and effective for use in humans for a specific indication.

Probiotics are live microorganisms (usually bacteria) similar to those already found in your gut.

They’re often called “good” or “friendly” bacteria because they help keep your gut healthy by maintaining a balance of microorganisms.

There are many different types of probiotics, and they can be found in a variety of foods and supplements.

So why don’t probiotics require FDA approval?

It’s because they’re classified as dietary supplements, which means they don’t need to undergo the same rigorous testing and approval process as drugs. Unless in rare cases where the manufacturers make specific health claims, probiotics don’t require FDA approval.

However, that doesn’t mean probiotics are entirely unregulated.

The FDA does have guidelines for the manufacturing of dietary supplements, and they can take action if a supplement is found to be unsafe.

In order to be marketed as a drug for treating diseases or disorders, a probiotic must meet even stricter specifications. Clinical trials must prove its safety and efficacy for its intended use, and FDA approval must follow.

The bottom line is: The regulation of probiotics by the U.S. government is complex. Based on how a probiotic product will be used, the Federal Drug Administration (FDA) may classify it as a food additive, a dietary supplement, or medicine.

This means that probiotic manufacturers don’t have to get FDA approval before selling their products.

However, the FDA does have the power to recall probiotic products that it deems unsafe.

When choosing a probiotic supplement, it’s important to look for one that has been manufactured according to good manufacturing practices and is third-party certified.

For example one of the few probiotic supplements I found while researching for this post is Probiology Gut+ which was made in the USA in a GMP-certified facility. I also learned that this probiotic supplement formula also passes a series of tests to ensure each bottle that leaves the facility contains live strains of probiotics.

So what should you look for when choosing a probiotic supplement?

Here are a few things to keep in mind:

  • Look for supplements that contain live, active cultures
  • Be sure to read the label carefully to make sure the supplement meets your needs
  • Choose a supplement from a reputable company that follows Good Manufacturing Practices
  • Talk to your healthcare provider if you have any questions or concerns about taking a probiotic supplement

Probiotics can be a helpful addition to your diet, but it’s essential to choose wisely.

By following these guidelines, you can be sure you’re getting a safe and effective probiotic supplement.

What are probiotics and what do they do for the body?

Probiotics benefits

Probiotics are live microorganisms, usually bacteria, that are thought to provide health benefits when consumed. Benefits such as improved digestion, a stronger immune system, and reduced inflammation.

Probiotics work by balancing the levels of good and bad bacteria in the gut, which helps to keep the digestive system functioning properly.

Research has also shown that probiotics can help to improve mental health by reducing anxiety and depression. In addition, probiotics are thought to boost the immune system by stimulating the production of antibodies.

The most common probiotics are found in dairy products and fermented foods, such as yogurt, kefir, sauerkraut, and kimchi. Probiotics are also available in supplement form.

When it comes to probiotics, more is not always better. In fact, too many probiotics can actually cause digestive problems such as gas and bloating.

It’s important to start with a small dose and increase gradually as your body adjusts.

Are probiotics medically proven?

Probiotics are considered safe for most people, and there has been increasing evidence in favor of the claims of beneficial effects attributed to probiotics, including improvement of intestinal health, amelioration of symptoms of lactose intolerance, and reduction of the risk of various other diseases, and several well-characterized strains of Lactobacilli and Bifidobacteria are available for human use.

Despite the promising evidence, probiotics should be studied further in order to find out their role in human health and whether they are safe.

Due to incomplete knowledge of what is necessary for their functionality in the gut, there are not enough characteristics known that are necessary.

Another research has it that probiotics can aid digestion and help maintain gut health.

And some potential benefits of probiotics have been seen in the treatment or prevention of:

  • diarrhea
  • irritable bowel syndrome (IBS)
  • ulcerative colitis
  • H. pylori (the cause of ulcers)
  • vaginal infections
  • urinary tract infections
  • recurrence of bladder cancer
  • eczema in children

And a few more.

While some studies have shown that probiotics can provide greater health benefits, more research is needed to confirm these effects.

If you’re considering taking a probiotic supplement, it’s important to talk to your healthcare provider first.

This is especially important if you have a health condition or take medication on a regular basis. Probiotics can interact with some medications, so it’s best to get the okay from your doctor before starting any supplement.

What are the dangers of taking probiotics?

The dangers of probiotics vary depending on the type of probiotic being taken. Some probiotics, such as those found in yogurt, are generally considered safe, while other types of probiotics, such as those that are taken orally as supplements, can have more side effects.

Some common side effects of taking oral probiotic supplements include stomach upset, bloating, gas, diarrhea, and constipation.

In some cases, people can also experience allergic reactions to the ingredients in probiotic supplements. And may interact with other medications that you are taking.

Additionally, there is some concern that taking too many probiotics could lead to problems such as antibiotic resistance or changes in the gut microbiome that could have harmful long-term consequences.

That said, a few of the probiotic supplements I’ve seen doesn’t come with any side effects because they were made using 100% natural ingredients.

For example, Probiology Gut+ probiotics supplements contain only clinically-backed, live probiotic strains that are completely safe, non-GMO, gluten-free, and completely natural.

probiology gut sample

With Probiology Gut+ probiotics supplement, the good gut bacteria are released into your small intestine once you have swallowed it, rather than getting dissolved in your stomach, which has been linked to stomach upsets, including gas.

Is Lactobacillus FDA approved?

Lactobacillus acidophilus DDS®-1 has been rated as Generally Recognized as Safe (GRAS) through scientific testing in accordance with 21 CFR 170.30(a) and (b), and thus does not require food, drug, and cosmetic pre-market approval under the Food, Drug and Cosmetic Act. (source).

Are probiotics worth taking?

Probiotics are worth taking for a few reasons.

First, probiotics help to restore the natural balance of good bacteria in the gut. This is important because when there is an imbalance of good and bad bacteria in the gut, it can lead to a variety of health problems such as indigestion, diarrhea, constipation, and even obesity.

Second, probiotics have been shown to improve immune function.

This is important because a strong immune system is essential for preventing infection and disease.

Finally, probiotics are also effective at reducing inflammation throughout the body. Inflammation is responsible for many common health problems such as heart disease, arthritis, and even cancer. So overall, probiotics are definitely worth taking for better overall health.

Who should not take probiotics?

Probiotics are generally considered safe for most people.

However, there are a few groups of people who should not take probiotics, including:

  • infants under the age of six months
  • pregnant women
  • people who are immunocompromised ( have a weakened immune system)
  • people who are taking certain medications, such as antibiotics or antifungal medications

If you fall into any of these groups, it’s important to talk to your healthcare provider before taking a probiotic supplement.

Final Thoughts

Probiotics are not FDA-approved. However, they are considered Generally Recognized As Safe (GRAS).

This means that they have a long history of safe use in foods and supplements. Probiotics are regulated by the Dietary Supplement Health and Education Act (DSHEA). The FDA does not approve dietary supplements before they go to market.

Rather, the DSHEA allows manufacturers to sell dietary supplements without prior approval from the FDA as long as the supplement labels accurately reflect the ingredients contained in the product.

Probiotics are a great way to improve your overall health and well-being.

However, it’s important to talk to your doctor before starting any probiotic supplement, especially if you have a health condition or take medication on a regular basis. Additionally, be sure to choose a high-quality probiotic supplement that contains only clinically-backed, live probiotic strains.

Probiology Gut+ is a great option for those looking for a high-quality, safe, all-natural, and effective probiotic supplement.

Learn more about Probiology Gut+ here

Brenda L. Mosley

Hi, Brenda here, I have been a health advocate and writer with 10 years of experience in health and nutrition. I also hold a BS in Nutrition Science and am based in Massachusetts with my family. My mission is to impact the world using my health and nutrition experience by sharing, writing, and educating on the internet - and offline too when possible. When I'm not busy writing or engaging in health forums and groups - you'll find me spending time with my 3 kids, eating, or reading literary fiction books.

Recent Posts