Attention copywriters. The FDA has taken out a bright red pen and is poised to mark up your product statements. The green shades (an antiquated description of newspaper copyeditors)  signaled much closer review of health claims with a warning to General Mills about oat cereal. The agency has also revised a health claim for selenium, rendering it useless to marketers. The size and stature of the companies involved suggests that all businesses, not just those operating in the back alleys, are subject to more intense scrutiny.

The FDA notified General Mills on May 5 that “your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.” On June 19, the agency changed the language for the prostate cancer health claim for selenium to to read as follows:

“Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”

After the new language was released, the Center for Science in the Public Interest filed a complaint with the FDA. In a letter dated June 29, the organization said that Bayer’s claims for its One A Day Men’s Health Formula vitamin overstated the health benefits related to prostate cancer. That followed a complaint filed June 18 with the Federal Trade Commission about marketing claims for the same supplement.

Why should the FDA put a spotlight on the giant companies when a Google search for other products would turn up claims that deserve equal if not more attention? The FDA does not respond to such inquiries, but the question may contain the answer: When a teacher gets tough with the biggest kids in a classroom, the little ones take notice and get in line. And given that both General Mills and Bayer both have backed off their product statements, it would seem that the FDA is very much in control.

Will there continue to be companies that ignore or try to test regulations on product claims? Of course. But the vast majority of nutritional supplement companies that want to play within the rules may become more conservative. Or at least more wary of FDA watchdogs.

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Connecticut Atty. Gen. Richard Blumenthal said the claim might be “voodoo nutrition” in pursuing an investigation of the drink, which contains caffeine. As a result of the agreement, Coca Cola and Nestle are re-labeling Enviga to add disclosures and disclaim weight-loss benefits, Blumenthal told news media. Any marketing of Enviga or a similar beverage that uses the terms “the calorie burner,” “negative calories” or “drink negative” must clearly disclose that the product doesn’t lead to weight loss without diet and exercise, he said.

Coca-Cola made the claim of weight loss based on studies that it claimed showed that caffeine combined with the green-tea antioxidant, EGCG, can increase calorie consumption.  Two years ago, the Center for Science in the Public Interest sued Coke and Nestle over the Enviga claims which it asserted were based upon “a 72-hour Nestlé-funded study of 31 people who were given a drink containing amounts of EGCG and caffeine equivalent to three cans of Enviga.”  CSPI claimed this study was insufficient substantiation for the calorie burning claims.  To read the complaint, click here.

Coca-Cola introduced Enviga in the United States in November 2006.  Since then the drink has come under scrutiny for its claims.

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The European Food Safety Authority (EFSA)

Taurine and d-glucuronolactone occur as natural ingredients in food, and are normal human metabolites. They are also usually used at much higher levels and in combination with different ingredients in energy drinks. The new data confirmed a No Observed Adverse Effect Level (NOAEL) of 1,000mg per kilogram of bodyweight per day for both substances.  Read the press release here.

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The Center for Science in the Public Interest (CSPI) has filed suit against Coke and Energy Brands claiming that the companies make deceptive and unsubstantiated claims on the VitaminWater line of beverages.  To read the press release, click here.

Coke markets VitaminWater as a healthful alternative to soda by labeling its several flavors with such health buzz words as “defense,” “rescue,” “energy,” and “endurance.” The company makes a wide range of dramatic claims, including that its drinks variously reduce the risk of chronic disease, reduce the risk of eye disease, promote healthy joints, and support optimal immune function.

To read the complaint filed in federal district court in California, click here.

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Included among the predicted trends:

• Fiber (according to National Starch Food Innovation)
• Vitamin K (according to PL Thomas)
• Phytochemicals
• Botanicals

To read the article, click here.

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Regulators said the beverage does not have enough nutrients to justify the use of the word “plus” in its name. According to the agency, foods labeled “plus” must have at least 10 percent more nutrients than comparable products. Additionally, the FDA said it is inappropriate to add extra nutrients to “snack foods such as carbonated beverages.” To read the complete warning letter click here .

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The National Advertising Division (NAD) of the Council of Better Business Bureaus has recommended that General Mills modify or discontinue certain advertising claims for the company’s Yoplait Yo-Plus product.

NAD, the advertising industry’s self-regulatory forum, examined broadcast, print and Internet advertising for Yoplait Yo-Plus, following a challenge by Dannon, the maker of Activia Yogurt, a competing product.

To read the press release, click here

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Participation deadlines:

• To make an oral presentation, Nov. 14th
• To participate, Nov. 28th

For important contacts and more information, click here.
The hearing will likely address the FDA’s past complaints that take direct aim at typical functional food properties and marketing strategies.
To get a better idea of what is at stake here, take a look at the this warning letter the FDA sent in May of this year to candy conglomerate Mars. Mars subsidiary Masterfoods recently launched a new line of functional foods called CocoaVia. The CocoaVia brand is marketed as “heart healthy” chocolate with such claims as “Promotes a Healthy Heart” and “Now you can have real chocolate pleasure with real heart health benefits.”

The functional food market includes big players. Some have forecast that the functional foods business could top $165bn by the end of the decade. There is a great deal at stake here.
Further information on functional foods and additional research sources:

• Food Safety Risk Analysis Clearinghouse — Functional Foods Page
• GAO Report: Improvements Needed in Overseeing the Safety of Dietary Supplements and “Functional Foods”

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Participation deadlines:

• To make an oral presentation, Nov. 14th
• To participate, Nov. 28th

For important contacts and more information, click here.
The hearing will likely address the FDA’s past complaints that take direct aim at typical functional food properties and marketing strategies.
To get a better idea of what is at stake here, take a look at the this warning letter the FDA sent in May of this year to candy conglomerate Mars. Mars subsidiary Masterfoods recently launched a new line of functional foods called CocoaVia. The CocoaVia brand is marketed as “heart healthy” chocolate with such claims as “Promotes a Healthy Heart” and “Now you can have real chocolate pleasure with real heart health benefits.”

The functional food market includes big players. Some have forecast that the functional foods business could top $165bn by the end of the decade. There is a great deal at stake here.

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