Judith L. Grubner

Phoenix dietary supplement company ThermoLife International, LLC, has sued Denver competitor MusclePharm Corporation in U.S. District Court in Arizona, claiming that MusclePharm’s Creatine supplement is infringing ThermoLife’s U.S. Patent No. 7,777,074 for amino acid compounds, including creatine nitrate, a vasodilator that increases blood flow. In its Complaint, filed February 1, 2012, ThermoLife contends that the stiff competition and ever-increasing market demand for the “next great muscle building supplement” results in dietary supplement makers frequently copying the successful products and ingredients of competitors, such as ThermoLife’s supplements. One such supplement is ThermoLife’s creatine nitrate product C-BOL.

The patent notes that creatine, which provides muscles with energy, is used by the dietary supplement industry to increase muscle-mass gains, improve athletic performance and strength. It is a nonessential amino acid that does not have to be obtained directly through diet because the body independently manufactures it. Taking creatine supplements is said to increase creatine production in the body. By itself, creatine has no vasodilating effect.

The patent also discusses “tolerance,” a side effect of nitrate compounds that occurs when a subject’s reaction to nitrate decreases so that larger dosages are needed to achieve the same vasodilution effect. The patent states that the presence of the amino acid arginine may prevent the development of nitrate tolerance (but it does not say the same for creatine nitrate compounds).

ThermoLife, founded by professional bodybuilder and promoter Ron Kramer, charges that MusclePharm’s Creatine product contains a “Creatine Matrix” of five types of creatine, including creatine nitrate, which ThermoLife describes as “a desirable additive to dietary supplements for athletes and others.” ThermoLife’s patent states that the creatine nitrate compound it discovered improves vasodilation over creatine, nitrates or nitrites alone, provides better circulation and distribution of the creatine amino acid in the body, improves absorption of the amino acid and requires a much lower dose to produce the vasodilation effect.

According to the Complaint, MusclePharm’s competition with Creatine has been effective enough to make it the No. 15 top selling product on BodyBuilding.com, which ThermoLife describes as the largest sports nutrition company in the world and most visited bodybuilding and fitness web site on the Internet. However, when Ron Kramer contacted MusclePharm’s co-president Jeremy DeLuca (former co-owner of BodyBuilding.com) to inform him of ThermoLife’s patent, MusclePharm did not stop selling its Creatine product, resulting in the lawsuit that charges MusclePharm with patent infringement, inducing patent infringement and contributory patent infringement. ThermoLife is seeking a holding from the judge that its patent is valid and enforceable, an injunction preventing MusclePharm from selling Creatine, destruction of all Creatine products, MusclePharm’s profits or a reasonable royalty from its sales of selling Creatine, triple damages and attorneys’ fees.

U.S. Patent No. 7,777,074, issued August 17, 2010, has only one independent claim – “An Amino Acid Compound consisting essentially of a nitrate or nitrite of an Amino Acid selected from the group consisting of Arginine Beta Alanine, Agmatine, Citrulline, Creatine, Glutamine, L-Histidine, Isoleucine, Leucine, Norvaline, or Ornithine.”

If this case goes forward, we can expect to see MusclePharm attacking the validity of ThermoLife’s patent. ThermoLife has also sued Pure Assay, Sechel Holdings (Ergogenix), SciLabs Neutraceuticals and others for including their patented amino acid nitrates in supplements. However, Gaspari Nutrition has requested that the U.S. Patent and Trademark Office reexamine ThermoLife’s patent, based on publications it claims contain references that will invalidate the patent. ThermoLife’s attorneys have disputed the relevance of those references.

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Joel B. Rothman

I have an article published in this month’s Nutritional Outlook that discusses our recent big win for energy drink maker Celsius in a class action filed against it in California state court.

My article discusses class actions challenging advertising and labeling claims for dietary supplements and food products in which companies are accused of making product claims that are unfair or misleading to a large group of consumers.  I note that in these cases consumer experiences with a product and its claims may differ greatly and, as a result, individual lawsuits, instead of class actions, may be more appropriate.

I argue in favor of an individualized approach to cases over deceptive claims.  In Celsius, the court recognized that this plaintiff could never prove whether the Celsius supplement product’s performance claims are true or not. Since this was an essential element of his claim, he lacked standing to show how he was damaged, and the class action case was dismissed.

As I have said elsewhere, I believe that we are seeing the beginning of a trend toward more individualized treatment of cases involving deceptive claims, and away from class actions.  The defense strategy companies adopt is critical and must focus the court on the plaintiff’s proof.

To read the decision in Fletcher v. Celsius, click here.

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Judith L. Grubner

Infomercials are popular methods for selling nutritional supplements and other products. However, they must follow the same rules that govern other advertising. The Federal Trade Commission (FTC) has authority under the Federal Trade Commission Act to regulate unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce. That includes the power to ban false advertisements, including infomercials. The FTC can sue to enjoin the false advertising and the offender can also be fined and/or imprisoned.

In 1998, the FTC charged Kevin Trudeau with falsely claiming in infomercials that certain products could cause significant weight loss, cure addictions to heroin, alcohol and cigarettes, and give users a photographic memory. He agreed to pay a $500,000 penalty and post a $500,000 performance bond. In 2003, the FTC charged him with violating the agreement by making cancer cure claims. In 2004, he agreed to pay a $2 million penalty and was banned from making infomercials except for publications where he truthfully represented the content.

In 2007, the FTC obtained a court order from the U.S. District Court for the Northern District of Illinois against Trudeau for misrepresentations he made on television about the content of his book, The Weight Loss Cure “They” Don’t Want You to Know About. In 2008, the judge ordered Trudeau to pay over $5 million and banned him for three years from making infomercials for products in which he had an interest. The FTC returned to court to have Trudeau held in contempt for violating that order in over 32,000 subsequent deceptive infomercials. In 2009, the court fined Trudeau $37.6 million and banned him from making infomercials for three years. On appeal from that order, the U.S. Court of Appeals for the Seventh Circuit required the judge to explain how he figured the fine and to modify the ban to allow Trudeau to make infomercials that did not misrepresent his book content.

The judge explained that the fine was calculated by multiplying the price of the book by the number of 800-number orders, plus the cost of shipping, minus any returns. The FTC was required to distribute the funds to anyone who bought the book using the 800 number and to return the remainder not used for administrative costs to Trudeau. The judge also required Trudeau to post a $2 million performance bond, effective for at least five years, to prevent further deceptive infomercials.

This time on appeal, the Seventh Circuit upheld the judge’s order as a “reliable and conservative” figure that compensated consumers for their losses incurred as a result of Trudeau’s contemptuous behavior. The judge was not limited to imposing relief based solely on Trudeau’s unjust profits. The fine could have been much higher, as the judge could have included bookstore as well as telephone sales because the books bore stickers saying “As Seen on TV.” The performance bond was also an appropriate remedy, as it would not be forfeited unless Trudeau makes more deceptive infomercials and the amount is low in light of Trudeau’s sales of thousands of books a day for many months. FTC v. Trudeau, No. 10-2418 (7th Cir. 11/29/11).

Last week, the Seventh Circuit issued its mandate after denying Trudeau’s motion for rehearing.  Trudeau now has 90 days to petition the U.S. Supreme Court to hear his case.  He tried that before and lost.  Expect him to try again.  But don’t expect much more than that.

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Irwin Naturals, one of the nation’s leading suppliers of natural dietary and herbal supplements, announces that it has reached a settlement with a California task force that named seven of its hundreds of products as being mislabeled or falsely advertised according to California law. The company has resolved all issues raised in the investigation.

The task force alleged that several Irwin products did not carry the proper lead warning label as required by California’s unique Proposition 65 law, but not that any of them contained an unsafe amount of lead. No product recall was or will be instituted as a result of the settlement, and no products were reformulated in response.

Proposition 65 requires a warning label for any product that contains an identifiable amount of a chemical or heavy metal on a daily dose basis. However, according to Prop. 65, the level of lead at which a product is considered unsafe is about 28 times greater than the level at which a warning on a label is required. As a result, Prop. 65 warnings have become ubiquitous throughout California on everything from wine bottles to Disneyland.

“We stand by our products, as we have for 15 years, and this settlement acknowledges that our products are safe and that we are in compliance with California laws,” said company spokesperson Rebecca Pearman. “As a trusted name in the nutritional supplement business, we are committed to best industry practices in manufacturing, quality assurance and labeling to ensure the quality and safety of our products and our continued leadership position in the industry.”

The task force also alleged that their tests failed to find Hoodia in some of the company’s products labeled as containing the herb. However, the company could not confirm these findings because no validated test method exists for identifying Hoodia in the softgel product form used by the company. The company relied instead on the industry standard method of confirming the input of Hoodia, and all manufacturing records confirmed that Hoodia had been put in to the products. The investigation did not result in either a product recall or reformulation.

Pearman said that while the company does not agree that it intentionally mislabeled or falsely advertised its products, it has no dispute with the task force’s fundamental objective to bring greater oversight to the nutritional supplement industry.

“For more than 15 years, we have staunchly supported the evolving standards under which our industry operates,” said Pearman. “California has some of the most stringent labeling laws in the nation, and in complying with those, we will continue to strive to meet or exceed all national requirements for our industry.”

Unrelated to the labeling claims was an allegation that the company failed to refund consumers who met the company’s refund policy. The task force did not identify specific complaints or consumers, but the company has set up a limited restitution fund. Consumers with questions about eligibility for refunds under the settlement can call the company at (800) 941-9098.

For the official announcement and more contact info on Irwin Naturals please visit 24-7 press release.

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Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found.

So begins an article in the New York Times on a Government Accounting Office report released May 26 that questions the safety of supplements. Could plaintiff attorneys be thumbing through the pages looking for defendants?

Very little in the report is news to the industry. A number of supplements  have trace amounts of ingredients that could be harmful in large doses. And questionable health claims are commonplace.

A government study carries weight in the mind of jurors considering product defect claims: Did a supplement make plaintiff sick? Did it contribute to health problems? Did the manufacturer take adequate steps to ensure the safety and quality of its product? This  is the stuff of litigation.

The report has led to the usual suggestions: better disclosure of ingredients on labels; better inspections of manufacturing plants; better enforcement of rules on product claims; and FDA power for recalls. None could prevent tainted products from being marketed and sold, so what legislation cannot do, litigation might.

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The Washington Post recently published an article asserting that vitamin D is shaping up to be the nutrient of the year, if not the decade. The article started factually strong but weakened at the end when it made specific recommendations.

The Post references an article in Consumer Reports titled “Most people get insufficient Vitamin D, but extra supplements may not be needed.” That article correctly notes that vitamin D blood levels in U.S. residents are on average below what is now thought by some experts to be what is needed for optimal health; the magazine perhaps overstates the case by writing that “…77% of Americans have insufficient amounts.”

In an article published last year in the American Journal of Clinical Nutrition, Elizabeth Yetley uses NHANES data to show approximately 6 percent of adults are below the traditional cut-off defining vitamin D deficiency and 77 percent are below what some nutritionists now opine to be the preferred target of 80 nmol/L.

The Consumer Reports article also points out what is putting the U.S. population at risk, primarily increases in obesity (fat sequesters some of the vitamin D synthesized in the skin) and less skin exposure to sunlight’s ultraviolet radiation.

The Institute of Medicine is currently reviewing the Dietary Reference Intake value for vitamin D, which was last updated in 1997. A final report is expected this May.  Currently, people 19 to 50 years of age are advised to consume at least 200  International Units per day,  those 51 to 70 at least 400 units, and those over 70 at least 600 units. Estimates are that adults get 100 to 150 units daily from food.

Consumer Reports goes astray when it writes: that people don’t need a special supplement; that overdosing is unlikely; and who should be advised to have their blood levels tested. Although makers of nutritional supplements are planning reformulations of their multivitamin products pending the institute’s report, most of what is on the shelves now is still at only 400 units.

What defines overdosing is up in the air. Officially, the Tolerable Upper Intake Level is 2,000 International Units per day. While bets are that the Institute will raise the adequate intake to 1,000 units per day, it is less clear whether the upper limit will also be increased. Writing in the American Journal of Clinical Nutrition, John Hathcock and his colleagues make a case for 10,000 units as a safe limit. The Institute has a conservative approach to upper limits.

Finally, people should not wait to get a blood test until they are diagnosed with weak bones or an absorption problem, contrary to what Consumer Reports says. Better advice would be for all adults to start taking 1,000 units per day from supplements. If you are in a higher-risk group for low vitamin D levels (obese, female, older, bypass surgery, Hispanic, African-American), get tested a few months later.

David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at david@dmarknutrition.com or 978-897-0890.

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The DEA’s actions are the equivalent of the carnival game, “Gopher Bash,” in which you take a soft, oversized mallet and bop gophers on the head when they emerge through holes in a playing surface. Even though you might strike all the gophers on the head, they keep popping up.

The DEA, FDA, nutritional supplement make, retailers and some athletes are all prisoners of this game. The DEA is trying to keep up with companies that synthesize new forms of steroids. In this instance, the agency declared off the shelves the following — Madol, boldione and 19-nor-4,9(10)-Androstadienedione. Because they are now considered anabolic steroids, retailers run the risk of arrest if they sell supplements containing those substances. Manufacturers and marketers have to find another way to market the substances, which may be available by prescription.

And as more substances make their way onto the DEA list, makers, distributors and stores will have to keep a close eye on what they should — and should not — be producing and stocking. And athletes have to watch what they keep on their shelves; they do not want to accidentally take a substance that was banned after they bought it.

Rather than notify the DEA of a problem substance, Travis Tygart, the head of the United States Anti-Doping Agency, said in a statement that, “We need a regulatory system capable of managing the magnitude of this problem, and that can stop those rogue supplement manufacturers who are meanwhile profiting.”

Who might that regulator be? The logical choice would be the federal  agency that oversees drugs and nutritional supplements. Whether the FDA wants the full responsibility is yet to be seen.

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David Frum

David Frum recently laid into the nutritional supplement industry with a guest commentary on CNN.com. The resident fellow at the American Enterprise Institute and one-time special assistant to President George W. Bush lashed out with the classic invectives against supplement makers and marketers. He wrote that any “snake oil flim-flam can be huckstered in the most truth-defying way” using that most evil of laws, the Dietary Supplement Health and Education Act of 1994.

Frum could have lowered his rhetorical blood pressure, without the help of a supplement, by reading the FTC regulations that go into effect on Tuesday. His column then would have begun: The party is over Dec. 1.

And the party — or at least marketing as it has been done for many years — does come to an end. Frum’s arguments against vague product claims no longer hold when the FTC — not the FDA — is watching what is said. The effects of the new rules are worth noting again: no more CYA disclaimers such as “results not typical” language; closer scrutiny of expert and celebrity endorsements; and careful review of consumer testimonials.

All the people who try a supplement and blog about it or are paid to write online reviews also have to disclose their relationships with those who supply them with products.

Frum can argue for repeal of the DHSEA, but he would be better off passing along tips of deceptive advertising to contacts he has at the FTC. That would produce more effective results than spouting off about his distaste for the supplement industry and its marketing practices.

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Vitamin B6

The headline in the Wall Street Journal read, “New Study Gives B Vitamin a Boost” and the first sentence in the article was, “Bring out the niacin.” It turned out that a vitamin — even only a prescription formula — produced better results than Merck‘s new cholesterol-lowering medicine, Zetia.

That was according to a 208-patient trial whose results were announced this month at the annual scientific meeting of the American Heart Association. Score one for the people who have say that vitamins support good health. The smart folks will not claim that niacin lowers cholesterol, but they can leave a copy of the article laying about.

Wait, there is something better. What product and in what dosage? Has it been patented? Uh, no. It’s called a placebo and its effect is often greater than any drug or nutritional supplement, scientists tell the Associated Press. Example: In tests of a new drug to relieve lupus symptoms, about a third of patients felt better when they got dummy pills instead of the drug. What’s more, Michael Perlis, a psychologist and neuroscientist at the University of Pennsylvania, says that he does not know of any herbal remedies for insomnia.

Darn. And it gets worse. A study published in the Nov. 18 issue of the Journal of the American Medical Association raised concerns that high does of folic acid could increase the risk of developing cancer. That could impact the more than $1 billion that is spent annually on B vitamins. Maybe consumers will think they are as better off popping Pez than a prescription pill or Internet-catalog vitamin. All a person has to do is believe that the little candy will make him or her better, and it will.

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As we have written before, makers of nutritional supplements should pay close attention to comments submitted to the FDA before February 2010. There will likely be advocates for warnings on all products that make a claim to support good health. The agency’s rules on search-based advertising for health products could encompass non-prescription items such as vitamins and muscle-building powders.

The ruckus in Washington on Nov. 12 and 13 stemmed from FDA warnings in March to drug makers that their search-based ads did not contain proper product warnings. Drug makers backed off their advertising, and the search-engine companies saw revenues plunge. Everyone hurried to Washington to ask the FDA for clarification.

Google presented a solution. It told the agency that sponsored links are now less transparent and relevant. Google then proposed a standard for product-claim sponsored links:

1. A headline that links to a product landing or home page.
2. A first line with the Web address for that page, followed by an information message.
3. A second line containing a safety warning that cannot be altered, followed by a link to a Web page with more details on the warning.

You can see sample Web pages by Google at Scribd. Other companies and public advocacy groups will likely have ideas on how to balance sales messages and product warnings. There may be software solutions such as pop-ups or Flash that could be integrated in order to present more information in an ad, but an elegant solution seems unlikely. Thus, the FDA could write rules that force makers and marketers of nutritional supplements to alter their sponsored links in ways they never wanted.

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