Thursday, September 22, 2011

Label Claims. @USANA Explains What It All Means.

Regulatory Affairs: A Crash Course on Label Claims

September 22 2011 written by Diana Yin
Have you ever wondered why and how supplement companies are allowed to make certain claims about their products?

For example, what makes something “high-fiber” or “high-potency?” What’s the difference between a supplement that “supports healthy immune function” versus one that states “antioxidant vitamins may reduce the risk of certain forms of cancer?”

And what are the regulations that companies have to follow when they make these kinds of claims?

I’ve often wondered the same thing and decided, once and for all, to understand what all these label claims really mean or at least become better informed. So I paid a visit to Howard Gurney, USANA’s Executive Director of Regulatory Affairs, for a quick course in label claims.

To give you some background, Howard and the entire legal/compliance department review every piece of PR/marketing material we create related to our products, from press releases to flyers to magazine ads — even this blog post. Simply put, they make sure we are as accurate as possible and ostensibly in good standing with the government and the public.

Getting Started

Let’s start with the basics. There are three types of Food and Drug Administration (FDA) labels on consumer products:
  1. Nutrition Facts
  2. Supplement Facts
  3. Drug Facts
Nutrition Facts are for foods. Supplement Facts are for nutritionals. Drug Facts apply to over-the-counter (OTC) drugs.
Curious to know if your bag of fiber powder is considered a food, a supplement or an OTC drug? Just look at the label. Know that from the perspective of FDA oversight, Nutrition Facts have the least rigorous rules. They’re followed by Supplement Facts and finally Drug Facts, which are more strictly monitored.

For a company to make any type of marketing claim on a product, the product (or specifically, an ingredient) has to have an FDA “daily value” (DV). For example, the government recommends that an adult get 25 grams of dietary fiber every day per a 2,000-calorie diet. However, it doesn’t list a DV for sugar. Therefore, you can make a health-related claim for a product containing dietary fiber, but not for sugar.
There are four types of claims you can make when marketing a supplement:
  1. Nutrient Content
  2. Structure/Function
  3. Approved Health
  4. Qualified Health

Nutrient Content Claims

Nutrient Content claims essentially tell you about the specific nutritional content of the product you are consuming, such as “low-fat,” “high-fiber,” or “a good source of.”
To say something “contains” an ingredient, it must have between 10-19 percent of the DV of that ingredient within the product. To say that a product is “high” in something, it has to have more than 20 percent of its Daily Value (such as calcium). To say that something is “high potency,” there must be more than 100% of the DV of that specific ingredient contained in the product.

Structure/Function Claims

Structure/Function claims pre-suppose that a healthy person is taking the product, so therefore the product is “supporting” or “maintaining” the consumer’s health. A company must have scientific research to support a certain claim, such as saying USANA’s Mega Antioxidant “supports healthy immune function” and be accompanied by the often-seen FDA disclaimer: “These statements have not been evaluated by the Food and Drug Administration…”

Approved Health Claims

Approved Health claims are interesting — they are health claims that the government has pre-approved for companies to use. However, the claim has to be printed exactly as the FDA has them written. For example, this common claim: “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.”

Qualified Health Claims

Qualified Health claims are the most restrictive. Like Approved Health claims, Qualified Health claims are a list of pre-approved claims. However, they are followed by an FDA disclaimer that discounts the original health claim: “Drinking green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce that risk because there is very little scientific evidence for the claim.”

This can be frustrating because for many of these claims, there is substantial evidence demonstrating the health benefits of something, but the FDA often lacks the resources to verify the claims, so it errs on the safe side through ambiguity.

Do Your Research

We understand why the government imposes the kinds of restrictions that it does. However, as consumers, I often find that the onus is on us to do our research and look up credible scientific sources to decide for ourselves what would be the healthiest choice for us.

I hope this blog post was informative and has helped some of you become better-informed consumers.
To read more in-depth literature on label claims, you can visit the FDA’s official website. Or to get some useful tips from the FDA on how to read your Nutrition Facts label, visit:

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