Why I Use Careful Wording About Probiotic Benefits

By Sally Robertson, owner of Upward Quest

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 long 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 interest 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 to advertise a particular health benefit. As a retailer, I want to respect that distinction.

What counts as a claim?

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 claims about dietary supplements when the applicable requirements are met.

However, 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 can cause a product marketed as a supplement to be regulated as a drug.

The distinction depends on the meaning of the statement and its context—not simply whether a particular word appears.

For that reason, a seller must consider the overall message customers receive from a page, advertisement, photograph, or testimonial.

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 standard disclaimer reads:

“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

That disclaimer does not replace scientific evidence. It also does not make an otherwise improper claim acceptable.

Does notifying FDA mean FDA approved the claim?

No. A structure/function notification is not an application for FDA approval.

The notification identifies the business, product, and exact claim. A responsible person must also certify that the information is complete and accurate and that the notifying business has substantiation showing the claim is truthful and not misleading.

FDA may object to a notification. Its current instructions explain that when it does not object, it generally does not send a response.

Consequently, receiving no objection is different from receiving approval. It does not establish that FDA has verified the product’s effectiveness or determined that every legal requirement has been met.

What about Body Biotics’ earlier submission?

The Body Biotics 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.

I mention this to explain the product’s regulatory history. I do not describe the submission as FDA approval.

I have chosen not to reproduce that list of benefits here. Publishing another company’s claims on a retail website can still communicate those benefits to customers as reasons to buy the product. Attributing a statement to its original author does not automatically remove the retailer’s responsibility for the message conveyed.

Why isn’t personal experience enough?

Personal experience matters to the person who has it. It can help explain why someone chooses a product or continues using it.

Scientific substantiation asks a different question: What evidence supports the particular effect being advertised?

Research must be relevant to the claim and to the product being sold. A study involving a different probiotic, a different dose, or a different group of people may not support the same statement about this product.

Similarly, a customer’s positive experience does not, by itself, establish what other customers should expect.

That is why I distinguish between telling you about my history with Body Biotics and promising a health result.

Do website and advertising platforms have their own rules?

Yes. Search services, marketplaces, and social media platforms may have their own requirements for supplement listings and advertisements.

A statement that meets applicable federal requirements may still be restricted under a particular platform’s policies. Federal requirements and platform policies need to be considered separately.

I do not assume that a platform’s decision means a product works or does not work. Nor do I assume that a manufacturer’s FDA notification guarantees that every platform will allow the same wording.

Is describing “how it works” different from making a claim?

Sometimes a description concerns a product feature or a general scientific concept. But explaining how a supplement affects digestion, immunity, or another bodily function can itself communicate a structure/function claim.

Calling something “educational” does not automatically change what the reader understands it to mean.

I therefore aim to be careful with explanations as well as with headlines and promises.

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.

My decision to use restrained wording is not a judgment about every other probiotic retailer. Different businesses may have different evidence, resources, and approaches to compliance.

It is the approach I have chosen for my shop.

The absence of a benefit claim on this website should not be interpreted as a promise of an unstated benefit. I want the information I provide to stand on its own, without asking you to read between the lines.

I have offered this product for many years because I believe in it. I also believe you deserve clear information, realistic expectations, and the freedom to make your own decision.

—Sally Robertson
Upward Quest

Sources and further reading

• FDA: Structure/Function Claims
• FDA: Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling
• FDA: Substantiation for Dietary Supplement Claims
• FTC: Health Products Compliance Guidance

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.