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FDA noticeably increased its enforcement of food and dietary supplement labeling violations last year.
FDA noticeably increased its enforcement of food and dietary supplement labeling violations last year. I believe the agency’s stricter approach to antioxidant claims, for example, indicates that manufacturers need to be more careful in the language they use on labeling and avoid making unauthorized implied nutrient content claims.
The agency issued at least three Warning Letters last year criticizing antioxidant claims for tea products. Two of the Warning Letters featured violations based on claims in labeling (on websites) for effects of antioxidants on disease, with the nutrient content claims listed as the second violations. (In Warning Letters, FDA generally lists violations in descending order of significance.) The third Warning Letter addressed only the nutrient content claims.
All three products made claims for antioxidants that used terms the agency had formally or informally designated as expressed or implied nutrient content claims. The claims included such terms as enhanced with, packed with, fortified with, abundantly found in, and rich source.
These terms clearly constituted claims that are not permitted for the flavonoid antioxidants in tea. Antioxidant claims are defined by regulation as available only to nutrients that have Daily Values and that exhibit antioxidant activity. The regulation lists vitamins C and E and beta-carotene as the only antioxidants known to FDA. A claim for any other Daily Value nutrient would have to be based on documentation that the substance had antioxidant function.
We advise clients who want to make antioxidant claims to avoid the types of terms cited in these Warning Letters. Except for “X mg (antioxidant)” claims, we advise avoidance of any terms that indicate the amount of the substance and the careful use of only phrasing that implies the antioxidant function of the substance.
In one instance, in spite of efforts to avoid terms that implied amounts of antioxidants, FDA was of the opinion that the language on the label referring to “the all-natural goodness and healthful blend” of the tea may be viewed as implying that the antioxidants were present in a significant amount when viewed in the context of the entire label. It is possible that FDA was influenced by the presence of “50% DV of vitamin C” in the list of antioxidants in the tea product, but even so, this is the strictest interpretation of what constitutes an implied nutrient content claim that we have seen from the agency.
The claims regulations have always included implied claims as well as express claims, and FDA has always stated that the overall impression of the label can be the basis for finding that there is an implied nutrient content claim. Because of the increased labeling enforcement activity, companies have already become more careful with language that could be implied disease claims. We believe they should also consider reviewing current labels for potential implied nutrient content claims.
While antioxidants are an established marketing trend, and consumers like the message behind antioxidants, the idea that antioxidants are a specific nutrient with clearly defined benefits is not as well supported in science or by the scientific community as many people would like to think. Antioxidants have a halo of wellness around them, but the fact is that they’re becoming a generic message.
As a consequence, in Europe, use of the word antioxidant became “illegal” starting in January, because the science does not substantiate the claims connection to antioxidants.*
* Editor's note: The author is referring to the European Parliament’s Regulation (EC) NÃÂ 1924/2006 (December 20, 2006) addressing nutrition and health claims for foods. In subsequent guidance on the law (December 14, 2007), the Standing Committee on the Food Chain and Animal Health specified (page 11 of the guidance) that antioxidant claims now likely fall in the category of a health claim (indicating functionality or an implied effect on health). A claim like "contains antioxidants" would not be considered a nutrient content claim, because there is no approved nutrient content claim for antioxidants. (Nutrient content claims are only those allowed by an approved list in the Regulation.) So, in essence, companies can no longer simply use phrases like “contains antioxidants” as nutrition content claims on food labeling. To make such a statement, they would have to go the health claims route and prove the physiological benefit to the body. However, in October 2010, EFSA, when asked by the European Commission to deliver an opinion on antioxidant Article 13.1 health claims, had a negative opinion on such claims. EFSA said that for claimed effects such as “antioxidant,” “antioxidant capacity,” “antioxidant properties,” “antioxidant activity,” and “antioxidant effect,” “the information provided does not establish that this capability as such exerts a beneficial effect in humans. No evidence has been provided to establish that having antioxidant activity/content and/or antioxidant properties is a beneficial physiological effect.” It can also be noted that in December 2011, EFSA echoed this opinion when asked to provide guidance on the scientific substantiation for a group of health claims, including antioxidant health claims (see here and here).
This is going to have a wash effect in the U.S. market. Already, regulators have looked more carefully, and with more questioning, at antioxidant claims.
Some people are incensed by this, of course. Some of them are rather upset because they think the science behind antioxidants is great, but it’s just not. The scientific community internationally applauds what Europe is doing, outlawing use of the word antioxidant.
What that means is that companies are going to have to move beyond simply stating “a source of antioxidants” and do enough science to substantiate a specific benefit.
What some companies are doing is replacing the word antioxidant with polyphenols, because polyphenols is a much more valid scientific term. The problem, however, is that consumers are much less familiar with the term polyphenols. So there’s a huge investment that’s going to be taking place in consumer education.
Certainly in Europe, you see some companies in transition. For instance, Welch’s started advertising not about the antioxidant benefits of Welch’s grape juice, but about the “polyphenol antioxidants,” for about a year. At the end of the year, they dropped the word antioxidants, hoping that consumers would continue to make the link.
Nestlé has a high-antioxidant coffee, and they are also switching to using the word polyphenols instead. And they’re specific. In their marketing, they can say “Up to X times the level of polyphenols as found in regular coffee,” because that’s a scientifically correct fact and polyphenols are a properly characterized component. But they wouldn’t be able to say that if they used the word antioxidant. Quite a big change.
The U.S. market is not going to have to make changes right away, but certainly everyone knows that regulators, FDA and the FTC, have been a lot stricter in the past 12 months, and there have been a few head-on attacks. So I think companies in the United States have a few years, but not many years, to steam ahead with their science to support their claims.