Many consumers see the Food and Drug Administration (FDA) as the watchdog for their best interests. So, when people find an FDA disclaimer on a supplement package, it may raise a red flag for any potential consumer. However, disclaimers should be no cause for concern. There are no regulations between FDA and probiotics because probiotics are considered a nutritional supplement. They are not intended to cure any ailment. However, they may help you live a better life. Let’s discuss.
- 1 Brief History of FDA
- 2 What is the Role of FDA?
- 3 Difference Between Supplements and Drugs
- 4 FDA and Probiotics Supplements Regulation
- 5 FDA and Probiotics: Who is Approved?
- 6 Is It Okay to Take Probiotics That Aren’t FDA-Approved?
- 7 Resources
Brief History of FDA
The roots of the FDA trace back to 1848 with the creation of the Agricultural Division in the Patent Office. Following the 1906 passage of the Pure Foods and Drugs Act, the FDA took on more responsibility in protecting consumers’ health.
As explained by the official FDA website,
“The 1906 Act was passed thanks to his efforts and in response to the public outrage at the shockingly unhygienic conditions in the Chicago stockyards that were described in Upton Sinclair’s book ‘The Jungle .'”– Food and Drug Administration (FDA)
Groundwork for the FDA was set forth by chief chemist of the Bureau of Chemistry of the U.S. Department of Agriculture, Harvey Washington Wiley. As he found the FDA, the position of chief chemist morphed into the commissioner of food and drugs.
From that day on, the lines between the FDA and probiotics supplements (and all other dietary supplements for that matter) became blurred.
What is the Role of FDA?
Over the course of the next century, consumerism hit a peak. Naturally, the role of the FDA amped up. They became an official division of the U.S. Department of Health and Human Services (HHS) .
Now, the government-run department has regulatory jurisdiction over the following:
|Regulated Product||Find Information about:|
|Human Foods||Foods for human consumption, including dietary supplements, and color additives|
|Human Drugs||Active pharmaceutical ingredients and both prescription and over-the-counter medications|
|Vaccines, Blood and Biologics||Biologic products such as human blood, blood donor screening tests, human tissue, embryos, human plasma, and medical devices for use in blood banking operations|
|Medical Devices||Medical devices such as first aid kits, pacemakers, and surgical instruments|
|Radiation-Emitting Electronic Products||Radiation-emitting products such as x-ray machines, microwave ovens, CD-ROMs, and laser pointers|
|Cosmetics||Cosmetic products such as shampoo, make-up, and face creams|
|Animal and Veterinary||Animal food and feed as well as veterinary medicines|
|Tobacco Products||FDA-regulated tobacco products such as cigarettes, smokeless tobacco, e-cigarettes and other electronic nicotine delivery systems, cigars, and all other tobacco products|
Each division of the FDA has its own set of regulations that manufacturers within those categories must follow. However, each department has the same core missions.
There’s a lot of information out there. Much of this news is hard for the average person to wade through. That’s why so many rely on the FDA.
The FDA ensures:
- Consumer Items Are Properly Labeled
- Consumer Items Are Generally Safe for Consumption
- Consumer Items Are Manufactured in Sanitary Conditions
- Consumer Items Don’t Serve as Potential Health Hazard
This agency protects consumers when they buy drugs their doctors recommend. Consumers also trust the FDA when they decide to purchase an all-natural supplement from the grocery store.
With these core values in mind, each division has a set of regulations unique to that division.
These regulations are based on how the products are made and the intended use of these items.
When it comes to the FDA and probiotics, supplements are considered food products. So, they are regulated in the same manner as your mustard.
Most people hold supplements in a different regard than they would their condiments. Sure, mustard improves your hot dog. However, supplements are supposed to support your everyday life! That’s where perception and reality gets a little murky for consumers.
Difference Between Supplements and Drugs
The reason people take supplements is that they want to improve their quality of life. However, many who purchase supplements sometimes expect these potential life-enhancers to be cure-alls. That’s why for legal reasons, all supplements will brandish a disclaimer on their label.
Disclaimers found on supplement bottles typically state:
“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”– FDA Disclaimer
As a potential consumer, that statement might be off-putting. However, if the consumer changed their perceptions of supplements, they might not be so turned off by this disclaimer.
Supplements are made of food-grade materials that are mostly organic compounds. While formulas are made in laboratories, supplements aren’t engineered in the same vein as a prescription drug.
The intention of a supplement isn’t to treat, cure, diagnose, or prevent. It’s to supplement all the other things you do to treat and prevent your own health. That’s why supplements don’t need to be pre-approved by the FDA like pharmaceuticals must.
For instance, probiotics supplements are intended to help fight off the growth of pathogenic bacteria.
However, it’s on you to eat a balanced diet, follow up with doctor visits, exercise, and do all of the other essentials for living a long, healthy life.
Just because supplements are classified as food items doesn’t mean the relationship between FDA and probiotics are over. Let’s take a look at the regulations the FDA has set on the supplement industry.
FDA and Probiotics Supplements Regulation
Probiotics supplements are in the FDA jurisdiction. They are classified as any other vitamin on the market. Let’s take a look at what that means in terms of FDA and probiotics regulation.
FDA Regulates Packaging Terms
As we mentioned above in the FDA mission section, this branch of the government is particular about verbiage. The FDA doesn’t want any consumer to feel misled. That’s why the FDA drafted The Dietary Supplement Health and Education Act of 1994 (DSHEA) .
As per DHSEA, all supplements must claim they are not intended to, “diagnose, treat, cure, or prevent any disease.” This verbiage points back to the differences between supplements and medications.
Doctors diagnose diseases, come up with a treatment plan, attempt to cure the disease with medication, and then discusses preventative measures with their patient.
That’s a lot of faith from a consumer and responsibility on a doctor and a drug company.
Therefore, drug manufacturers must meet a far more extensive list of demands from the FDA than a supplement company.
FDA Enforces Good Manufacturing Practices
Harkening back to the Chicago debacle in 1906, the FDA ensures that all manufactured items are created inside sanitary conditions. The FDA performs regular inspections to ensure compliance.
Based off these inspections, the FDA reserves the right to remove any items they deem as hazardous from the marketplace. If the FDA approves, then they will issue a certificate of Good Manufacturing Practices (GMPs). Look for this seal of approval when buying probiotics supplements.
FDA Marks Genuinely Recognized as Safe
One of the most significant regulations between FDA and probiotics is the Genuinely Recognized as Safe (GRAS) mark. Any food and supplement manufacturer must provide a list of the active and inactive ingredients in their product.
The FDA has a database of chemical compounds. This database ranks the potential dangers posed by these ingredients. The ingredients in a product are compared to those on the FDA list. If most of the ingredients listed show little to no side effects on humans, then the product is deemed GRAS .
FDA and Probiotics: Who is Approved?
The FDA makes sure there’s nothing in a supplement that can potentially harm you. They see to this by ensuring a safe manufacturing process and by cross-checking the ingredients for potential health dangers. That’s where the relationship between the FDA and probiotics ends.
As long as supplements remain under the Human Foods division of the FDA, there will not be any FDA-approved probiotics supplements. If so, then then the supplement would undergo more rigorous testing. At that point, supplements would be classified as Human Drugs rather than Human Foods.
Is It Okay to Take Probiotics That Aren’t FDA-Approved?
The thing about the FDA is that it’s a great tool to filter out the really bad products out there. However, there’s some accountability on the consumer as well. Not every product is going to provide the same experience for one person as it will for another. So, see for yourself.
Under the FDA’s eyes, you know that probiotics supplements are made in a safe environment with ingredients that aren’t hazardous to your body. With that worry out of the way, do some research.
Just because the FDA hasn’t regulated it, doesn’t mean research on the benefits of probiotics hasn’t been done. While microbiome studies are in the early stages, the research is very promising.
In fact, one government analysis of probiotics states:
“Probiotics may have a variety of effects in the body, and different probiotics may act in different ways.
– National Center of Complementary and Integrative Health
— Help your body maintain a healthy community of microorganisms or help your body’s community of microorganisms return to a healthy condition after being disturbed
— Produce substances that have desirable effects
— Influence your body’s immune response .
As you can see, that statement was made by the National Center of Complementary and Integrative health. We want to emphasize the complementary and integrative aspect of their name. That’s the purpose of supplements.
In addition, the quote states probiotics have a “variety of effects” and “different probiotics may act in different ways.” That is why the Thryve Gut Health Program implements microbiome testing.
We know the bacteria in your gut biome, and you as an individual are both unique. So, we attempt to supplement your lifestyle by tailoring your probiotics supplements for your gut biome.
 Commissioner, Office of the. “When and Why Was FDA Formed?” U.S. Food and Drug Administration, FDA, www.fda.gov/about-fda/fda-basics/when-and-why-was-fda-formed.
 Commissioner, Office of the. “FDA Fundamentals.” U.S. Food and Drug Administration, FDA, www.fda.gov/about-fda/fda-basics/fda-fundamentals.
 “Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress.” NIH Office of Dietary Supplements, U.S. Department of Health and Human Services, ods.od.nih.gov/About/DSHEA_Wording.aspx.
 Center for Food Safety and Applied Nutrition. “Generally Recognized as Safe (GRAS).” U.S. Food and Drug Administration, FDA, www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras.
 “Probiotics: What You Need To Know.” National Center for Complementary and Integrative Health, U.S. Department of Health and Human Services, 22 Aug. 2019, nccih.nih.gov/health/probiotics/introduction.htm.