Sally by a stream in the Colorado mountains

Why I Use Careful Wording About Probiotic Benefits

If you have looked around my website, you may have noticed that I describe Body Biotics, its history, and its practical features without making a list of promises about what it will do for your health.

That is a deliberate choice. I want you to understand why.

I began taking and selling Body Biotics in 1997, when it was known as Nature’s Biotics. My decision to offer it grew out of my personal belief in the product. After all these years, I still take it and still sell it.

But my personal experience and my confidence in a product are different from the scientific evidence required by law to advertise a particular health benefit. As a retailer, I want to respect that distinction.

What counts as a claim of benefits with the FDA?

A claim is a statement that tells—or suggests to—a customer what a product can do.

Some claims concern straightforward product details, such as the number of capsules in a bottle or whether refrigeration is required. Other claims describe an effect on the body.

For example, “supports healthy digestion” and “supports a healthy immune system” are commonly used examples of what FDA calls structure/function claims.

“Structure” refers to parts of the body. “Function” refers to what those parts do. A structure/function claim describes how an ingredient or supplement affects or helps maintain the body’s normal structure or function.

Even gentle wording such as “supports” or “helps maintain” can communicate a health benefit. Those words do not remove the need for evidence.

Are supplement sellers allowed to describe health benefits?

Yes. Federal law permits certain structure/function claims about dietary supplements when the applicable requirements are met.  The requirements involve scientific studies and a tedious process of getting FDA approval. 

Describing support for a normal bodily function is different from claiming that a supplement diagnoses, treats, cures, mitigates, or prevents a disease. Disease-treatment claims will cause a product marketed as a supplement to be regulated as a drug.  In my opinion, probiotics are not drugs and they are not treatment for disease conditions.

How I personally think about probiotics

I personally think of probiotic supplements as part of nutrition, rather than as cures for medical conditions. Although we call them “friendly bacteria,” they are living microorganisms. I do not present them as cures for medical conditions.

I do not offer Body Biotics as a treatment for disease or as a replacement for medical care. My belief in the product is one reason I have continued taking and selling it for so many years, but that belief is separate from promising that it will correct a medical problem.

What is required for a structure/function claim?

For dietary supplement labeling, the requirements include:

  • Substantiation: The business making the claim must have evidence showing that it is truthful and not misleading.
  • Notification: The entity making the claim must notify FDA no later than 30 days after first marketing the supplement with that claim.
  • A disclaimer: The claim must be accompanied by the required FDA disclaimer, presented according to the applicable rules.
  • Appropriate wording and context: The claim must not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.

The Body Biotics Manufacturer’s  submission of a structure/function claim in 2010

The Body Biotics Manufacturer’s website posts a structure/function notification dated June 8, 2010, identifying Body Biotics products and listing 22 proposed claims.

The company’s accompanying announcement describes a submission of more than 700 pages, including scientific literature and supporting summaries. It reports that the notification received no opposition.  For claims like this it is common that the FDA does not give approval, they simple offer no opposition to the claim.

Do website and advertising platforms have their own rules?

Yes. For me, the website hosting services I use with Etsy and Shopify and the marketing services with Pinterest do have their own rules to make sure FDA policies are followed.  I have found that, even though Body Biotics has submitted a structure/function claim, these companies do not have a way of knowing about those claims. 

So the result of all this is I simply do not make any claims.

My approach at Upward Quest

I focus on information that helps you understand what you are buying: product and label details, its name history, storage requirements, ordering information, and my background as a longtime seller.

I have offered this product for many years because I believe in it.

—Sally Robertson
Upward Quest LLC

Sources and further reading

This page explains my approach as a retailer and provides general information about U.S. supplement marketing requirements. It is not legal or medical advice.

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