Bodybuilding.com has recalled 65 products containing suspected anabolic steroids as part of a cooperative arrangement with the FDA. According to Functional Ingredients Magazine:

The FDA has informed the Company that it believes that the Recalled Products contain ingredients that are steroids. Specifically, the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” While the Company has not had an opportunity to independently confirm the FDA’s concerns, the company is undertaking this voluntary recall in an abundance of caution.

Click here to read the rest of the article (inc. the list of recalled supps).

Paul posted a rant about Kellogg’s Froot Loops and Apple Jacks last week, so I figured I’d pile on too… Can’t let him have all the fun, after all.  According to a recent press release:

Kellogg Company Discontinues Immunity Statements On Rice Krispies Cereals

BATTLE CREEK, Mich., Nov. 4 /PRNewswire-FirstCall/ — Kellogg Company today announced its decision to discontinue the immunity statements on Kellogg’s Rice Krispies cereals.

Last year, Kellogg Company started the development of adding antioxidants to Rice Krispies cereals. This is one way the Company responded to parents indicating their desire for more positive nutrition in kids’ cereal.

While science shows that these antioxidants help support the immune system, given the public attention on H1N1, the Company decided to make this change. The communication will be on pack for the next few months as packaging flows through store shelves. We will, however, continue to provide the increased amounts of vitamins A, B, C and E (25% Daily Value) that the cereal offers.

We will continue to respond to the desire for improved nutrition, and we are committed to communicating the importance of nutrition to our consumers.

Why are they doing this now?

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According to Reuters, the “Smart Choices” labeling program has  “voluntarily” postponed “active operations” - pending an investigation by the FDA.  Some companies, like Kraft, intend to continue using the system on existing products, but will not expand its use. Kellogg, however, intends to phase it out completely.

It’s funny what a little public scrutiny can accomplish, isn’t it?

Remember this?  Looks like the so-called “Smart Choices” labelling system is drawing critics with teeth.

Raising the stakes in the battle over nutritional claims for packaged foods, the Connecticut attorney general said on Wednesday that he was investigating a national labeling campaign that promotes products like Froot Loops and mayonnaise as nutritionally smart choices.

In letters to Kellogg’s, General Mills and PepsiCo, the attorney general, Richard Blumenthal, said he was concerned that the program, called Smart Choices, was “overly simplistic, inaccurate and ultimately misleading.” The three companies are among several food giants that participate in the program.

In an interview Wednesday, Mr. Blumenthal said he had discussed his investigation with attorneys general from other states and several had expressed interest in joining his effort. In other prominent consumer protection cases, states have worked together to pursue companies or industries, including cigarette makers and subprime lenders, over charges of deceptive marketing.

“As a matter of common sense, these sugar-laden or fat-saturated products seem very questionable as so-called ‘Smart Choices’ nutritionally,” Mr. Blumenthal said. “We’re ratcheting up pressure for truthful answers to these issues.”

The Connecticut investigation will seek to determine if the labeling campaign violates the state’s consumer protection law, which bars misleading or false product claims, he added.

Personally, I’d be delighted to see Mr. Blumenthal roast the industry over a sloooow fire for this one.  Stay tuned…

I’m of two minds about this…

In an effort to limit how much sugar and fat students put in their bellies at school, the Education Department has effectively banned most bake sales, the lucrative if not quite healthy fund-raising tool for generations of teams and clubs.

The change is part of a new wellness policy that also limits what can be sold in vending machines and student-run stores, which use profits to help finance activities like pep rallies and proms.

As a health/fitness professional, obviously I don’t support having a lot of junk food in schools.  But as a former parent-teacher organization member/officer, I also have a lot of sympathy for student groups and clubs that are being deprived of a popular fund-raising tool.

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Evidently it’s “truth or consequences”…

Under the revised Guides, advertisements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect. In contrast to the 1980 version of the Guides – which allowed advertisers to describe unusual results in a testimonial as long as they included a disclaimer such as “results not typical” – the revised Guides no longer contain this safe harbor.

…the post of a blogger who receives cash or in-kind payment to review a product is considered an endorsement. Thus, bloggers who make an endorsement must disclose the material connections they share with the seller of the product or service.

LOL – if the FTC follows through, maybe this will put a damper on some of the more outrageous and deceptive ad practices.  We’ll see…

According to the New York Times, the law mandating that chain restaurants in NYC post the calorie counts of their food isn’t working… or so a recent study reports.

The study, by several professors at New York University and Yale, tracked customers at four fast-food chains — McDonald’s, Wendy’s, Burger King and Kentucky Fried Chicken — in poor neighborhoods of New York City where there are high rates of obesity.

It found that about half the customers noticed the calorie counts, which were prominently posted on menu boards. About 28 percent of those who noticed them said the information had influenced their ordering, and 9 out of 10 of those said they had made healthier choices as a result.

But when the researchers checked receipts afterward, they found that people had, in fact, ordered slightly more calories than the typical customer had before the labeling law went into effect, in July 2008.

…Tameika Coates, 28, who works in the gift shop at St. Patrick’s Cathedral, ordered a Big Mac, 540 calories, with a large fries, 500 calories, and a large Sprite, 310 calories.

“I don’t really care too much,” Ms. Coates said. “I know I shouldn’t, ’cause I’m too big already,” she added with a laugh.

April Matos, a 24-year-old family specialist, bought her 3-year-old son, Amari, a Happy Meal with chicken McNuggets, along with a Snack Wrap for herself. She said with a shrug that she had no interest in counting calories. “Life is short,” she said, adding that she used to be a light eater. “I started eating everything now I’m pregnant.”

Nutrition and public health experts said the findings showed how hard it was to change behavior, but they said it was not a reason to abandon calorie posting.

NYC is conducting its own, considerably larger study, so this isn’t the final verdict, although the early returns don’t look promising.

It’s time for another round of congressional and agency posturing over dietary supplements… particularly those that – in the words of this New York Times article - “illegally contain steroids.”

Now Congress is investigating whether laws, health agency resources and manufacturing guidelines are adequate to protect the public from products that illegally contain steroids but masquerade as dietary supplements.

…Testifying on Tuesday at a Senate hearing on bodybuilding products, Travis T. Tygart, chief executive of the United States Anti-Doping Agency, estimated that hundreds of illegal products containing steroids were now available in the United States. As evidence of the problem, Mr. Tygart introduced Jareem Gunter, a former college baseball player who said he suffered acute liver failure after taking a bodybuilding product called Superdrol.

“Jareem had no way of knowing that a regulatory scheme designed over 15 years ago for a few companies selling a limited number of simple vitamins and mineral supplements has been hijacked by unscrupulous profiteers,” Mr. Tygart told members of the Senate Judiciary Committee Subcommittee on Crime and Drugs at the hearing on bodybuilding products.

…Mr. Tygart, of the Anti-Doping Agency, recommended legislative changes that would give the agency greater power over dietary supplements both before and after they go on sale.

There’s really only one word to describe this song and dance: it’s horses**t.

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It probably is. 

Although this lawsuit was filed back in May, it just made it across my radar screen… and it’s too good an illustration of this principle to pass up.

Claim to boost testosterone meets class-action lawsuit
Posted by Hugo Ottolenghi

The company says that its product will boost testosterone levels by 10,000%. The plaintiffs says the product is snake oil marked up to $70 a package. So begins a class-action lawsuit filed in California superior court May 6. The suit says that Musclemeds makes false advertising claims about Arimatest and that the product creates a false result when tested.

Scott J. Ferrell of Call Jensen & Ferrell of Newport Beach, Calif., represents two California men plus others who would qualify for class-action status. The suit seeks “to recover millions of dollars generated by defendants via the false and misleading claims.”

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More evidence of an FDA crackdown on steroid-based supplements.

Thursday’s raid followed a two-year criminal investigation into the company and corporate officers, including founder Ryan DeLuca, by the U.S. Food and Drug Administration, according to search warrants filed in U.S. District Court.

The searches were conducted at Bodybuilding.com’s headquarters at 2026 S. Silverstone Way, Meridian, and its warehouse off Gowen Road in south Boise…

…Between February 2008 and last August, Robert Blenkinsop, an FDA special agent based in Boise, made four purchases from the company, he said in an affidavit filed in support of the search warrant.

Of the 31 products he bought, 23 tested positive for one or more of five anabolic steroids: madol, tren, superdrol, androstenedione and turinabol, he said in the affidavit.

Local news video here.

About time, too.

As a part of its ongoing monitoring program and in conjunction with an initiative with the Council for Responsible Nutrition to expand the review of advertising claims for dietary supplements, NAD – the advertising industry’s self-regulatory forum – requested that the company provide supporting evidence for advertising claims that included:

People who take Stemulite Experience:

• Deep REM Sleep
• Increased Muscle Gain and Endurance
• Increased Weight Loss and Fat Loss
• Increased Wellness and Energy

…NAD was also concerned about testimonials on the Stemulite website, including:

• “Within Two Days of Using Stemulite, I Slept Great!”
• “I Have Noticed A Tremendous Energy Boost.”
• “Using Stemulite, I Have Seen Results in 2-3 Weeks”
• “In Three Days, Suddenly My Sleep Was Fantastic.”
• “I Am Getting Eight Hours of Restful Sleep, It’s A Miracle”
• “I Had A 6 Pound Loss In A Short Period Of Time”
• “In Just 5 Days, My Endurance Has Increased 25%”

The advertiser contacted NAD, and despite requesting and being given an extension of time within which to file its response, failed to do so. The advertiser represented to NAD that it would be conducting a study in the future and would participate after the completion of the study.

Wonder why they decided to stonewall?  Anyone want to take a guess?

First, Oprah… according to the Chicago Tribune:

Alleging Internet marketers are using her name without permission, Oprah Winfrey–through her corporate vehicle, Harpo Inc.–on Wednesday filed a federal trademark infringement suit against 40 peddlers of dietary supplements.

…Last year, Oz praised the anti-aging properties of the acai berry.

Not long after, Internet marketers began to sell acai products with implications that they had been endorsed by Winfrey or Oz, said Marc Rachman, an attorney for Harpo. But neither has ever sponsored such a product, he said.

The same phenomenon has occurred involving the health benefits of other substances aside from acai berries. “The subject is discussed on the show, then the scams start. It’s brazen,” Rachman said. But acai berries have been a particular magnet for alleged misdeeds.

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I’ll be curious to see how this one plays out…

The Food and Drug Administration is being sued. (Not for the first time.) This time, it’s by supplement companies who don’t like the way the agency denies or waters down the “qualified health claims” they can put on their wares.

…You can see why the companies don’t like the way the FDA alters the qualified claims they allow. One claim cited in the lawsuit started out as “Vitamin E may reduce the risk of bladder cancer. The scientific evidence supporting this claim is convincing, but not conclusive.”

It was changed to: “One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, the FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.”

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Another lawsuit’s in the works: the Cancer Project – a vegan-oriented physician’s group concerned with dietary approaches to cancer prevention/survival - is suing the major hot dog manufacturers for fraud on behalf of three New Jersey consumers.

WASHINGTON—Three New Jersey residents are suing Nathan’s Famous, Kraft Foods/Oscar Mayer, Sara Lee, Con Agra Foods, and Marathon Enterprises for failing to warn consumers that hot dogs increase the danger of colorectal cancer. The action comes in the wake of landmark scientific studies linking hot dogs and similar meats to colon cancer.

The class-action consumer fraud lawsuit, which is being filed July 22 in Superior Court in Essex County, seeks to compel all five companies to place cancer-risk warning labels on hot dog packages sold in New Jersey. The labels would read “Warning: Consuming hot dogs and other processed meats increases the risk of cancer.”

The nonprofit Cancer Project is filing the suit on behalf of John O’Donnell, Ruthann Hilland, and Michele DeScisciolo, who purchased hot dogs made by the companies without being made aware that processed meat products are a cause of colorectal cancer.

“Just as tobacco causes lung cancer, processed meats are linked to colon cancer,” says Neal Barnard, M.D., president of the Cancer Project. “Companies that sell hot dogs are well aware of the danger, and their customers deserve the same information.”

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This time it’s FXsupplements.com, the makers of Acai Berry Maxx.

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… For selling “designer steroids”.

The supplements, Tren Xtreme and Mass Xtreme, are manufactured by American Cellular Labs and marketed as a “potent legal alternative to” steroids. But authorities alleged in search warrants executed on Thursday that the supplements contain illegal man-made steroids, also known as designer steroids. One of the substances is Madol, which was first identified six years ago during the investigation into the Bay Area Laboratory Co-operative.

ACL isn’t the only one, either.  I expect more companies and supps will be targeted in the near future.

Sigh…

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.

The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.

The government’s complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.

The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.

During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.

FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.

“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”

Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.

Which is something that certain supp manufacturers/retailers evidently don’t understand.

Earlier in the week, I clicked through an interesting presentation given at the recent International Society of Sports Nutrition conference.  Entitled “Sports Supplements, Science, and the Politics of New Washington“, it offered some explicit warnings to the supplement industry.  As authors Rick Collins, JD, CSCS and Alan Feldstein, JD put it in a section headed “Self-Regulation or More Regulation”:

If companies making unsubstantiated claims continue to be reported in the press, and lawsuits and class actions proliferate, FDA and FTC may ratchet up their scrutiny.

Indeed. 

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This press release sez it all…

SPRINGFIELD, Mo. – Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Michigan business owner pleaded guilty in federal court today to his role in a conspiracy to fraudulently market dietary supplements over the Internet with illegal claims that these supplements could prevent, treat or cure a number of diseases. Several Web sites were used to sell nearly $12 million worth of the products in 2005 and 2006.

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That’s the title of this Wall Street Journal Blog post – and it sure puts some perspective on all the howling about the dangers of “unregulated supplements.”

Now, a panel of outside experts convened by the agency is meeting to discuss ways to reduce the risk of overdose associated with acetaminophen, the active ingredient in Tylenol. The FDA’s briefing memo says the numbers aren’t entirely clear, but cites one study that suggested acetaminophen overdoses were associated with 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths per year in the U.S. during the 1990s.

Part of the issue is that “there is little difference between the maximum recommended daily dose and a potentially harmful dose,” the FDA says. The agency lays out a few possibilities for dealing with this, including reducing the maximum daily dose and the single adult dose.

One other possibility mentioned in the memo: Getting rid of products that combine acetaminophen with other drugs, on the grounds that consumers may not know acetaminophen is in their medicine, so may take multiple products that contain the drug. Acetaminophen is in lots of cold products — including NyQuil, one of the all-time OTC classics.

56,000 emergency room visits, 26,000 hospitalizations and 458 deaths per year?  I don’t know of any supplement that even approaches the level of risk that “tightly regulated” drugs like acetaminophen does.  If we’re going to save people from themselves, then perhaps that’s the place we should start.