Food and nutrition long have been intertwined, with advances in nutrition science spurring innovation in product development. How much of an ingredient or nutrient must be added to justify a label or advertising claim? The appropriate answer is taught in law school: “It depends.” It does depend, but certain regulatory guideposts should be considered.

Many claims are expressly defined by regulation. By law, so-called nutrient content claims (e.g., “low fat,” high fiber”) and health claims (e.g., “potassium may reduce risk of stroke”) are specified for each approved claim. A “high fiber” claim must contain at least 20% of the daily value for fiber. At least 6.25g of soy protein per reference amount qualifies a food for a claim touting the relationship between soy and a reduced risk of heart disease. Note that often many other restrictions may apply beyond the level of the nutrient highlighted in the claim.

Touting a food's contribution to meeting the Dietary Guidelines (DG) requires calculations as referenced in the current MyPyramid. The still relatively new DG for the first time move away from “servings.” Although consumers may not yet be comfortable with quantities expressed in “ounce-equivalents” and other such measures specified in the DG, this is the direction the government is moving. The DG provide a useful benchmark for ascertaining what is a meaningful amount of a key nutrient.

“Structure/function” is a distinct category of claims that has emerged in the past decade to convey the contribution of functional nutrients/substances that support the proper functioning of the body. These claims, like statements of dietary guidance, require no government pre-approval. Apart from the amount, care must be taken to avoid framing a claim in a manner that represents the product as a drug.

In 2003, FDA issued a draft guidance surveying the necessary support required to make a structure/function claim. The approach paralleled that long used by the Federal Trade Commission (FTC) in evaluating advertising claims. FDA focused on the following:

* The meaning of the claim
* The relationship of the evidence to the claim
* The quality of the evidence
* The totality of the evidence

The second and third factors are most pertinent to the “How much must I add?” question. Directed toward dietary supplements, the draft guidance is applicable to conventional foods as well.

Ideally, the supporting science is the result of directly studying the particular food or supplement bearing the claim. Alternatively, and more commonly, the level (and, in many cases, the type) of the claimed nutrient or ingredient used in the particular formulation should be comparable to the levels studied. For example, studies that show greater satiety with foods containing 15g of fiber, 8g of fat and 30g of protein may not provide support for the launch of a new satiety-positioned product with 10g of fiber, 3g of fat and 20g of protein. The strength of the study and the validity of the end-point studies are among factors to be evaluated in determining if the marketer's planned product formulation warrants a claim.

Unlike the FDA, the FTC does not distinguish between the different categories of claims, due to its broad statutory mandate to prohibit “deceptive advertising practices.” For the FTC, the key question is not so much how you frame a claim as whether you can support what you say. The FTC typically will apply criteria for a claim already defined by the FDA and will otherwise examine the specific evidence and the underlying body of science relevant to a particular diet/nutrition claim.

As with the FDA, the FTC will examine if the advertised food contains the type and amount of a touted nutrient or ingredient as is reflected in the scientific literature relied upon by the advertiser. Anecdotal evidence is generally insufficient, and any limitations of the science must be communicated effectively as part of the claim. Great care should be taken in how the claim is framed. Often, an advertiser runs into trouble by making a claim that goes beyond the level of proof relied upon.

A marketer must formulate a product with that level of the key nutrient or ingredient that establishes an objective, scientific basis for the claimed function or benefit. A review of regulations and the underlying science is a necessary step in advance of any well-conceived marketing strategy.

Steven Steinborn, Hogan & Hartson LLP, represents food and dietary supplement companies on a range of product development, marketing and regulatory compliance, and enforcement issues involving the FDA, the USDA, the FTC and Consumer Products Safety Commission. His e-mail is: SBSteinborn@HHLAW.com.