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.

• None Found

This is a tale of two types of weight-loss products and how the Food and Drug Administration had different responses to similar problems with them. The separate, but not equivalent treatment raises questions about how the FDA operates.

On Aug. 24, the FDA issued a statement about an ongoing safety review of orlistat based on reports of liver injury in people taking the weight-loss drug. It is marketed as the prescription drug Xenical and the over-the-counter medication Alli.

The FDA said it had received 32 reports of serious liver injury in patients taking orlistat between 1999 and 2008.  Of those cases, 27 required hospitalization and six resulted in liver failure.

Sound familiar? It should. On May 1, the FDA issued a warning about the danger of Hydroxycut based on 23 reported liver problems over seven years, including 16 hospitalizations. One person died in February 2007 after taking that weight-loss product.

That is where the stories diverge. For orlistat, the FDA is conducting a review because, “no definite association between liver injury and orlistat has been established at this time,” according to the release. “Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.”

In contrast, the FDA told consumers to stop immediately using Hydroxycut even though the agency acknowledged in a health hazard evaluation board report that “The Board does not know what ingredient(s) of Hydroxycut are responsible for producing liver toxicity. In addition, there is insufficient information to determine whether there is a dose-response effect between Hydroxycut ingestion and liver disease or whether its effects are cumulative over time.”

Despite a lack of direct evidence, the board concluded “that the ingestion of the dietary supplement, Hydroxycut, presents a severe potentially life-threatening hazard to some users.” The makers of Hydroxycut immediately ordered a recall.

What might the same health board members think about orlistat? It has caused liver injuries for a longer time period and has put more people in the hospital with similar ailments — jaundice and liver failure.

Does the FDA give greater weight to the patient death? If so, it seems to us that the product would have been recalled in 2007.

Is the difference the way the products are regulated? The FDA approved Xenical in 1999 and Alli in 2007. None of the ingredients in Hydroxycut were identified in the report as needing FDA review.

If the distinctions are not clear from a review of the facts, then what are we to expect the next time a weight-loss product is associated with health problems?

• None Found

What has not changed since our first blog on Aug. 2, 2005, is our mission. So it is worth republishing the first entry by our founder, Joel Rothman. For those of you who were not present for the launch, here is the original post:

Welcome friends to the first legal weblog devoted entirely to the nutritional supplement industry. This first post will give you the what and why of this blog, as in what I am going to write about here and why I am writing it. For more information on who I am, click the “About” link on this page.

Okay, what is this blog about? It’s about all forms of nutritional and dietary supplements, vitamins, neutraceuticals and cosmeceuticals, the laws that regulate them, and court cases concerning those laws. It’s about laws regulating supplement safety, advertising and sales. It’s about lawsuits brought by those claiming to have been injured by supplements, and lawsuits brought by and against companies in the supplement business. It’s about the claims dietary supplement manufacturers make in big bold letters on the front of the box, and the disclaimers in tiny letters on the back of the box. It’s about other things too that strike my fancy. So that’s the what.

The why is pretty simple. From time to time I represent nutritional supplement manufacturers. In the past I have found it difficult to get current, topical and useful information about the laws and cases that matter to my clients. Other lawyers I know have also told me that there is really no place to go on the web that addresses legal matters of concern to this young and growing industry. So, I hope to provide some measure of assistance to those like me looking for a resource like this.

Now, a word about what this blog is not. Since I have already said that I have clients in the business, you might have figured out that this blog is not a place to find a lawyer to sue supplement manufacturers because you think you got sick or hurt from taking dietary supplements or using cosmeceuticals. There are lots of lawyers out there who I am sure will listen to you and they are easy enough to find. This is also not a blog that rails against nutritional supplements and the people who make them. This is not a blog about the pros and cons, this is a blog about the legal environment in which nutritional supplements are made and sold. If you have something to say about what is good or bad about a particular pill, creme or protein shake, we are interested only if there are legal implications to it. This blog is also not legal advice, so don’t use it as such and we disclaim any liability to you and yours should you disregard this warning.

So there you have the what and the why. Again, the who is linked on the sidebar. Now, let’s get busy with some content!

• None Found

Some of us remember when parents would chase their children out to play in the sun, with no protection other than play clothes.  Today, the Federal Trade Commission tells us

overexposure to the sun’s invisible rays – ultraviolet A (UVA) and ultraviolet B (UVB) – can cause skin damage. The damage can be immediate and long-term, with effects ranging from sunburn, rashes, and cell and tissue damage to premature wrinkling and skin cancer. Indeed, many skin changes that often are identified with aging actually result from damage by too much sun. . .To help reduce your risk of skin damage from sunlight, try to minimize your exposure to the sun between 10 a.m. and 3 p.m., when the sun’s rays are strongest. Even casual exposure to sunlight – driving a car, walking to the store, taking an outdoor lunch break – contributes to cumulative lifetime exposure. If you’re out during the peak hours, wear a hat and tightly-woven clothing that covers your body, and use maximum protection sunscreens.  It’s important to understand the labeling information on sun protection products and shop carefully before heading to the beach, tennis court or park. The FTC carefully monitors advertising claims in this area and offers this information to help you make wise purchasing decisions.

Consumers have taken this advice to heart, driving a highly competitive market in sun protection products.

A battle between Schering-Plough and Neutrogena over their respective advertising claims for sunscreens is heating up.  A few months ago,    Schering-Plough, maker of Coppertone  Sport sunscreens, sued major competitor Neutrogena, maker of  Ultimate Sport sunscreens, for alleged false advertising claims favorably comparing the benefits of Neutrogena’s Helioplex sunscreen formula to Coppertone’s formula.  The alleged false claim is that a sunscreen must have Helioplex to provide UVA and/or UVB protection.  Schering-Plough also complained that Neutrogena was falsely claiming that its ULTIMATE SPORT product was the “Best line of sport sun protection.”

Neutrogena fought back with counterclaims that Schering-Plough’s Coppertone Sport ads were falsely claiming that only Coppertone NutraShield with Dual Defense provides both UVA/UVB protection and antioxidants that promote skin repair, that Schering-Plough’s TV commercials falsely claim that 28% of the Ultimate Sport product sprayed on a body is chemical propellant, that Coppertone Sport sprays provide “better protective coverage” than Neutrogena’s sport sprays and that the Coppertone sprays provide better sun protection than the Neutrogena Ultimate Sport sprays.

In this Lanham Act case in the federal district court in Delaware, Schering-Plough is currently trying to obtain a preliminary injunction against Neutrogena’s sunscreen advertising claims that, if issued,  would include corrective advertising obligations.    Neutrogena is also asking the court for an injunction against Schering-Plough’s advertising claims.  It will be a long hot summer for these combatants.

• None Found

GUEST BLOG by David A. Mark

The Institute of Medicine is currently reviewing the Dietary Reference Intake value for vitamin D that last changed in 1997. While a final report is not expected until May 2010, some dietary supplement companies are boosting their dosages now. The increases have implications not only for consumer health but for regulatory action.

The Tolerable Upper Intake Level for vitamin D for adults today is 2,000 International Units per day. The Daily Value is 400 units. Depending on a person’s age, the Adequate Intake is between 200 and 600 units. Those numbers could go higher once the Institute issues its report.

Most people get 100 to 200 units of vitamin D daily from their food. Most multivitamins provide a daily dosage of 400 units. Some manufacturers have begun to offer products with 1,000, 2,000 and even 5,000 units per day. The last is more than double the current upper limit.

Is there a benefit – or a danger — from getting more vitamin D? A growing scientific consensus says that a combination of food, dietary supplements and the typical exposure to sunlight is not sufficient to reach blood levels for ideal health.

While the cumulative evidence supports an increase in the figure for adult intake of vitamin D to perhaps 1,000 units per day or higher, there is not an equivalent body of new evidence sustaining an argument for a safe, higher upper limit.

The identified risk of chronic, high, vitamin D consumption is elevated serum calcium, resulting in inappropriate tissue calcification. The current Daily Recommended Intake text identifies 3,800 units per day as leading to abnormally high serum calcium. The text also says that 2,400 units per day produces an elevated serum average, but still within the normal range. This was a small, short study without evaluation of clinical consequences. Ongoing, massive, multi-year vitamin D clinical trials may detect subtle negative outcomes. Researchers will keep an eye out for harm to kidneys and arteries.

It is reasonable to assume that the Food and Drug Administration is also watching the situation. It would not surprise me if the agency issued warning letters to companies selling vitamin D products containing 2.5 times the current upper level, telling those businesses that their products are potentially unsafe.

FDA action is not the only risk. Recently, the FDA amended the qualified health claim for selenium. Shortly thereafter, the consumer advocacy group Center for Science in the Public Interest filed a complaint with the FDA against Bayer Healthcare, stating that the existing (now superseded) label claim for One A Day Men’s Health Formula overstated the putative prostate cancer health benefit. The Center also said that recent research suggested that selenium supplementation might increase risks for hypertension and diabetes.

The center and other non-government organizations might take the same action against high-dose vitamin D products, potentially creating negative publicity, especially if new research links them to negative health effects. The supplement industry would be wise to prepare for such developments.

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.

• None Found

Manufacturers beware. Your regulatory problems may not be over when you pull a product from the store shelves. Matrixx Initiatives Inc. recalled its Zicam products on June 16 and three days later the Securities & Exchange Commission sent a letter of inquiry. The company said that it did not know what the regulatory agency wanted, according to an article in the Wall Street Journal.

Mattrix is a public company, so it serves many masters, including the SEC and shareholders. The company’s stock lost 70 percent of its value the day the recall was announced. Shares closed at $4.83 on June 23, down another 95 cents from the June 16 close.

As might be expected, users of Zicam products have sued Mattrix. Among the latest is a Fort Lauderdale attorney who defends homeowners against foreclosures. Not a likely plaintiff based on his practice, his claim is based on the fact that he lost his sense of smell in 2007. He attributes that to the use of Zicam and now he wants compensation for damages.

The SEC focuses not on customer, but shareholder losses. A letter of inquiry can be a first step into an investigation that can lead to civil and criminal charges. Or it can lead to nothing; the SEC does not comment on its actions until they are final.

Matrixx stock had survived the downturn in the general market. It was trading near a 52-week high of $19.74 when the Food and Drug Administration issued a warning about certain Zicam products. In May, the company reported that 2009 revenues had hit a record level and annual earnings per share had jumped 40 percent from fiscal 2008 levels. In the earnings press release, acting company president Bill Hemelt said, “The 11% increase in fiscal 2009 net sales was driven primarily by increased sales within our core Zicam Cold Remedy and Allergy/Sinus products.”

Zacks Investment Research had rated the company a strong buy, saying in a release dated May 8 that “The Zacks #1 Rank (Strong Buy) company has now topped the consensus forecast in each of the last 4 quarters with an average upside surprise of 28.48%.”

When a stock on a big upswing suddenly goes into a tailspin, the SEC takes notice. Even if the reason for the decline is obvious, there are questions to be answered.

• None Found

Outside the industry, the viewpoints were more pragmatic. Scot Long, an exercise physiologist and professor from Mississippi, weighed in, writing: “Bottom line, do I think that Hydroxycut is an evil product? No. I think many people abused this product (taking too much) and some may have even had pre-existing medical conditions. Do I recommend it to my students, clients and friends? Of course not. I do think, however, that Iovate Health Sciences could have made a safer product. But it shouldn’t shoulder all the blame.”

Marion Nestle, author of “Food Politics,”  wrote in her San Francisco Chronicle column, “I freely concede that most supplement companies make reliable products, but without federal oversight how is anyone – even a store clerk – supposed to know which ones they are. Some clerks may know their business, but in my experience few think critically about the products they are selling and most appear to take the manufacturers’ words at face value.”

After a Hydroxycut recall article was posted on FitSugar.com, a commenter who goes by the name Mondaymoos offered this first-person experience : “I never took diet pills for the purpose of losing weight. Me, and a lot of other people in the military, used them as a tool to work 12 hour shifts and still go out and have a life afterwards without racking up massive calories in energy drinks and soda. Was it a healthy decision, probably not. Did it work? Definitely yes.”

Consumers seem to know that there are no magic diet pills and that abusing a product is probably harmful. Thus, rhetoric that casts the FDA — or a manufacturer — as hero or villain does not sway consumers. They would rather know the benefits and risks of a product, and make an informed choice based on that.

• None Found

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.”

Musclemeds claims that Arimatest boosts testosterone much more than competitors’ products, according to the lawsuit. The product inhibits estrogen and elevates action via AI-1 and AI-2 aromatose-inhibiting ingredients.

The plaintiffs claim that the product “does not boost actual, bonded testosterone by 10,000% or anything like that.” The suit further says that Musclemeds claims in advertisements and product labels to have a patent pending for its Fastorb Technology are false because no such application exists.

Arimatest is a synthetic testosterone supplement that is promoted as improving the user’s physical fitness by preventing its conversion to estrogen, according to the suit. The results should be an increase in muscle mass, increased strength or improved stamina. The main ingredient is ATD, which the suit says shows higher testosterone levels when tested through radioimmunoassay methods.

The advertised claim of higher levels is false and the defendants know it, the suit says. ZRT Laboratories, which is cited as the source of research supporting the 10,000% claim, has twice demanded that Musclemeds stop using the lab’s name in its advertising.

In a declaration filed in U.S. District Court on May 4,ZRT marketing director Steve Forsyth wrote, “ZRT did not conduct any research according to scientific methods that would support the research findings being attributed to ZRT by the manufacturer of Arimatest.” Forsyth also said that, in January, he “also had serious doubts about the accuracy of the scientific assertions and representations contained in Arimatest advertising.”

The suit seeks damages based on violation of the California Legal Remedies Act, unjust enrichment, fraud, violation of the California business and protections code, and breach of warranty.

• None Found

Jessica Hardy

A swimmer who missed the Olympics says she doesn’t have a drug problem: A Texas supplement company does.  Jessica Hardy claims in a lawsuit that AdvoCare International Co. caused her to be disqualified from the U.S. team because the products Arginine Extreme and Nighttime Recovery were contaminated with clenbuterol, an anti-asthma medication similar to albuterol, that is banned. The legal battle could have far-reaching effects on company liability.

Advocare has taken the unusual step of suing Hardy for defamation, saying that her claims are infringing on the company’s ability to do business, especially with swimmers. In an article in the Dallas Morning News, company attorney Allison Levy says that Advocare wants to clear its name.

The two sides have conducted laboratory tests with conflicting results. Informed-Choice says Advocare’s products are clean; Anti-Doping Research says that the products contain clenbuterol. The back and forth in court could take years. If there is a trial, the outcome could have a ripple effect on the supplement industry. A win by Advocare might help companies that face civil charges from other athletes who claim that poor manufacturing practices damaged their careers and incomes.

If Hardy prevails, supplement makers might face higher product-liability insurance costs. They may also have to shy away from lucrative athlete markets and could lose valuable endorsements. Even if the matter is privately settled, the legal entanglement again highlights the need for have a good manufacturing process. Advocare’s defense could depend mightily on demonstrating that it took appropriate care.

• None Found

Sergio Mitre

J.C. Romero

Major League players J.C. Romero and Sergio Mitre say they unwittingly consumed androstenedione when taking substances that they bought at GNC. The most famous baseball player to use the steriod is Mark McGwire and this week the slugger was not voted into the Baseball Hall of Fame.

Romero and Mitre say the ingredient was not listed on the labels of Halodrol from Gaspari Nutrition and 6-OXO Extreme from ErgoPharm. And that raises the question of liability. Mitre and Romero will not be paid while suspended for 50 days. Mitre may sue for lost wages and reputation. GNC says that the players are responsible for following league rules.

For the moment, the problem lies with the players. That could change, of course. Other athletes have gone to court over what they considered mislabeling. The message to athletes is clear: consume at your own risk. The lesson for manufacturers is still to come.

• None Found