In a statement, commission chairman Jon Leibowitz said, “We expect more from a great American company than making dubious claims – not once, but twice – that its cereals improve children’s health. Next time, Kellogg needs to stop and think twice about the claims it’s making before rolling out a new ad campaign, so parents can make the best choices for their children.”

In a joint statement, Leibowitz and commissioner Julie  Brill used stronger language: “As a trusted, long-established company with a presence in millions of American homes, Kellogg must not shirk its responsibility to do the right thing when it advertises the food we feed our children.”

Kellog had a run-in with the FTC over its Frosted Mini-Wheats that resulted in the company’s admission that health claims made for the cereal were false and a settlement order in February 2009. Kellogg agreed not to claim “benefits to cognitive health, process, or function provided by any cereal or any morning food or snack food unless the claims were true and substantiated,” according to the statement on the Rice Krispies order.

Leibowitz and Brill said in their joint statement that even as Kellogg was pulling back on the Mini-Wheats claims, it must have been moving forward with health claims on the Krispies cereals.

“The company clearly has the means and ability to carefully test its children’s food products to determine if the products in fact provide health benefits for kids,” the commissioners said. “We are also confident that Kellogg has the wherewithal to carefully develop truthful and nonmisleading advertising about such health benefits.”

Kellogg responded with a statement saying that it stands behind the validity of product claims and research. “So we agreed to an order that covers those claims,” their statement said.

The expanded order now prohibits Kellogg from “making claims about any health benefit of any food unless the claims are backed by scientific evidence and not misleading.”

This is familiar ground for makers of nutritional supplements, but not so much for a manufacturer whose advertising icons include three guys in hats and a cuckoo bird. (Cocoa Puffs had the claim, too.) Kellogg, and General Mills whose Cheerios heart-health claims drew a warning letter from the Federal Drug Administration, are now learning what it’s like when you emblazon words like “immunity” and “antioxidants” on product packaging.

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This time, the news report is real. In an earlier blog, we identified News 13 and News 29 as faux-TV news Web sites that touted the health benefits of resveratrol and acai. Our search of public and other records linked them to a company in Hollywood, Florida, among other locations. We told readers to stay tuned for an update.

CBS News — the real network — reported July 29 on what appears to be the same Hollywood-based company, FWM Laboratories, in a national broadcast and an accompanying Web story headlined, “Buyer Beware: Web Supplement Scams.” Some of the Web site visuals in the TV report (such as the Resveratrol Ultra Web page) are the same we saw in our research. Some had prominent mentions of CBS News and its “60 Minutes” news show as sources of information about the benefits of resveratrol. That may have prompted the story.

Kelly Cobiella

In its reporting, CBS discovered an “F” rating from the same regional Better Business Bureau and a multitude of Web sites that FWM uses, though it is not clear if the faux-TV stations were among them. Kelly Cobiella, a real reporter from CBS, found the company’s offices. She toured the sales and shipping departments, and had a sit-down with CEO Brian Weiss who looked, in our opinion, a little uncomfortable. He told Cobiella, “We’ve sold to million and a half customers since November. So in the overall picture, the number of complaints seems high, but it’s low when compared to the number of orders we’ve shipped out.”

The Web story follows with this: “In fact, FWM is one of the most complained-about companies in the nation. The Florida Attorney General is investigating the company and the Federal Trade Commission is looking into the marketing tactic they – and companies like them – use. News organizations including CBS have tried to get FWM and others to stop misusing their reports to sell products.”

Signature statements from Walter Cronkite and Paul Harvey come to mind, but let’s think about consumers. One FWM customer told CBS News that he signed up for what he thought was one 99-cent sample bottle, but received and was billed for two more at $87 each.

Do billing practices like these reflect well on the industry as a whole? If not, what can be done so that other sellers of resveratrol and acai are not also labeled as scammers?

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David Ortiz

The confusion surrounding steroid use in professional baseball has taken another strange turn. The Associated Press and New York Times report that eight of the 104 players who tested positive for steroids in 2003 fall into another category. The AP says that the eight did not test positive; the Times says that the eight took 19-norandrostenedione, which was legally sold over the counter at the time. It is now illegal and a player caught with it in his system will be suspended for 50 games.

David Ortiz has said from the time his name was publicly tied to the list that he had been taking vitamins. At a press conference on Aug. 8 before his Boston Red Sox played host New York Yankees, Ortiz said that he had bought supplements in the Dominican Republic and the United States. “I’m not here to make any excuse or anything,” according to a Times article. “I really used a lot of supplements and vitamins.” He added that companies would send him supplements, “but I never used or buy any steroids.”

Former Red Sox teammate Manny Ramirez, Yankee Alex Rodriguez and former Chicago Cub Sammy Sosa were also on the 2003 list. But for what? The details are in the hands of federal investigators, the players’ union cannot tell its members, and a federal judge has told everyone to keep their mouths shut.

Any language confusion in identifying nutritional products may seem unimportant to the public, but to folks in this industry there is a huge difference between a vitamin and a steroid. Or a supplement and a steroid.

When companies do not make the distinction to the satisfaction of the FDA, they hear about it. In October 2004, the agency wrote a warning letter to All American Pharmaceuticals and Natural Food Corporation regarding the labeling of the prohormone as a dietary ingredient. “FDA is not aware of any information demonstrating that androstenedione, 19-norandrostenedione, and 5-androstene-3b 17b-diol were lawfully marketed as dietary ingredients in the United States before October 15, 1994,” the letter said in part.

Apparently, 19-norandrostenedione is pretty strong stuff: “One of the most frequently misused steroid precursors (prohormones) is 19-norandrostenedione (4-estrene-3,17-dione, NOR), which is, after oral administration, readily metabolised to nortestosterone, also known as nandrolone (durabolin),” begins the abstract to a study published in 2008 on the prohormone. Its effect on the careers of All-Star players and Major League Baseball is being felt today.

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Hamburg

The FDA has put supplement companies on notice that violators can expect earlier detection and prosecution. Remarks by commissioner Margaret Hamburg on Aug. 6 strongly suggest that the agency has shifted to a policy of less talk and more action. In a speech to the Food and Drug Law Institute, Hamburg said the FDA will be more vigilant, strategic, quick and visible.

To that end, Hamburg said the FDA has instituted six policy changes:

• Fewer, if any warnings. “If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter,” Hamburg said.
• Greater emphasis on swift enforcement. “When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses,” she said.
• Fewer warning letters. The letters are now limited to significant legal issues. “Most enforcement letters will be able to move forward through a more streamlined process.,” Hamburg said.
• Shorter post-inspection deadlines. “When the FDA finds that a firm is significantly out of compliance, we expect a prompt response,” she said. “The firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action.”
• More follow-up on enforcement actions. “After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices,” Hamburg said.
• Public notice of completed corrections. “We will provide to the firm a ‘close-out’ letter, indicating that the issues in the warning letter have been successfully addressed.”

In sum, a supplement maker can expect a knock on the door before getting a letter in the mail. If the FDA perceives a significant risk to public health, it will ask enforcement agencies to take immediate steps. In some circumstances, there will be no warning and no negotiation before a plant is shut down or a product is recalled.

Why is the change in policy needed? Hamburg, who has been on the job just 90 days,  pointed to slow action on serious violations regarding product quality; adulteration and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising. Agencies took to long to respond because of procedures and policies, she said.

The industry response must be to get better or get out. Get better at controlling ingredient quality; get better at manufacturing; get better at documentation; get better at advertising and marketing; get better at legal representation. Otherwise, get out of the business.

While the actions may seem harsh, they increase the public’s confidence in the dietary supplement industry, Hamburg said.  “The solution is a commitment to compliance backed by a strong compliance program. Now is a good time to reassess whether you have such an effort in place.”

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