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Friday, June 10, 2016

A Guide to Dietary Supplement Claims

Science

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You’re reading through a marketing brochure for a new LifeVantage product and you start to wonder—why doesn’t LifeVantage say anything about the product diagnosing, preventing, or treating any number of diseases? The reality is, because we can’t. Here’s why…

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA) – a piece of legislation that provided a regulatory framework for supplements, ensuring continued access to safe products made to quality standards.

The reason this piece of legislation was put in place was because 1) dietary supplements are not considered drugs or food additives and thus, required a different set of regulations; and 2) Congress saw the need to recognize the value of supplements and the contribution they can make to promoting health.

So, if you thought that dietary supplements weren’t regulated, think again.

Dietary supplements are considered a subset of foods under federal law and are therefore regulated by the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC).

Here is a breakdown of the FDA’s and FTC’s regulations regarding claims…which will hopefully clear up any confusion as to why we (LifeVantage) can only make limited claims regarding our products.

What’s a “claim”?

The FDA and FTC define a “claim” as something said or implied on the label or in the advertising materials for a product. In the dietary supplement world there are a number of different types of claims, all of which are regulated by the FDA and FTC in some way. When it comes to LifeVantage, the two types of claims that are most relevant are – health (disease) claims and structure/function claims.

A “health claim” is about the relationship between the product (or its ingredients) and a disease or health-related condition. This type of claim requires significant scientific agreement and must be authorized by the FDA before the product is made available to the public.

We CAN’T make claims that our products treat, diagnose, cure or mitigate diseases. Those types of claims can only be made about medications or drugs that have been approved by the FDA.

We CAN, however, make structure/function claims.

A “structure/function claim” is about the product’s effect on a specific structure or function of the body. This type of claim does not require pre-approval by the FDA but does require the following –

  1. Substantiation to verify that the claim is not false or misleading,
  2. A disclaimer wherever the claim is found, and
  3. A notice of the claim being made must be sent to the FDA no later than 30 days after the first marketing of the product with the claim.
  • Put simply – Structure/function claims must focus on the supplements ability to promote health by supporting normal body function. These claims cannot infer that the supplement has an effect on abnormal body functions or conditions (which indicates a diseased state).
  • Keep in mind – Because there are many conditions associated with a natural state or process but can be associated with abnormal conditions that are diseases, the context and wording of the claim is very important (see example below).
    • “Product X helps to relieve occasional stress and frustration” might imply treatment of anxiety disorders. But, because these conditions are also characteristic of non-disease states, as long as there is no context linking them to disease, this would be an appropriate structure/function claim.

Why do the FDA & FTC care about claims?

The FDA and the FTC are government agencies that protect consumers. These agencies make sure that consumers understand exactly what they are buying. The way they protect the consumer is to regulate what a company like LifeVantage says to a consumer about its products. They divide the work up like this:

  • The FDA pays attention to the product’s label; and
  • The FTC pays attention to the product’s advertising materials for that product.

These agencies pay close attention to what the company says as well as how the consumer might interpret what the company said. Anything a company says about a product must be “truthful, not misleading, and substantiated”. “Misleading” can mean that some important information was left out. “Substantiated” means that the statement has valid scientific backing, such as proven in a study. Both of these agencies want consumers to get accurate information about dietary products so they can make informed decisions when they buy them.

What happens if LifeVantage makes a false or misleading claim?

Both the FDA and the FTC take false or misleading claims very seriously, and it’s possible that they would levy heavy fines against a company. The FDA and the FTC can file lawsuits on behalf of consumers against companies making claims. Sometimes, these lawsuits have such heavy penalties that companies must shut down.

What does LifeVantage do to ensure it complies with the FDA & FTC dietary supplement regulations?

We are very careful to follow all the FDA and FTC rules. Below is a brief description of our internal process.

1. Product Substantiation

In the product development stage, the Research & Development (R&D) team collects information from previous studies that substantiate the efficacy and safety of the ingredients to be used in the new product. Once the formula is finalized, studies are conducted on the product to verify its effectiveness as well as to better understand how the product works as a whole.

Specific information is then pulled from each study and dropped into a robust substantiation document. Because this information includes complicated terms that are not great for marketing purposes (in other words, are likely only compelling to a scientist), the R&D and Marketing teams work together to take the compiled information and create “marketing claims”. These claims are then reviewed by the lawyers and, once approved, can be used on marketing materials to help promote the product.

Example (from PhysIQ product line):

Scientific Claim
Fructooligosaccharides selectively stimulate the growth of bifidobacteria thus modifying significantly the composition of the colonic microbiota. This is beneficial because it is accompanied by a significant reduction in the number of bacteria reported to have pathogenic potential.
*Roberfroid, M. (1997). Health benefits of non-digestible oligosaccharides, UBTC, Pharm Sciences; pg 211-219.

Marketing Claim
Fructooligosaccharides are a group of naturally occurring carbohydrates that can help promote the growth of beneficial bacteria in the gastrointestinal tract. This, in turn, stimulates healthy digestion.

2. Disclaimer

We include a disclaimer on all materials with claims.

Example:

“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.”

3. Notification & Approval

We notify the FDA of claims to be made about each product. Also, we only use language that has been approved by the LifeVantage R&D and Legal teams when we talk about scientific evidence and studies that have been done with our products.

4. Training & Legal Review

Additionally, we train everyone who is involved with labeling or marketing at LifeVantage in the nuances of “express claims,” “implied claims,” “net impression,” and all the other concepts these agencies care about. Our legal department reviews everything we say about a product to ensure that we are following the rules exactly.

How does this affect me?

Everyone – company employees and independent distributors – who participates in the marketing efforts of LifeVantage products must follow the FDA and FTC rules. Make sure that anything you say about a LifeVantage product is “truthful, not misleading, and substantiated.” Pay close attention to the language provided by LifeVantage as it will help you to promote our amazing products in a way that is both compliant and compelling!

Resources

The U.S. Food and Drug Administration (FDA)

Consumer Healthcare Products Association

The Council for Responsible Nutrition

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