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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Lesson #1: Do not copy someone else’s advertising. Just because the other companies make product claims does not mean it is OK. The FTC might penalize all of you. The FTC settled with Airborne for $30 million in August 2008 and with Rite-Aid, seller of Germ Defense, in July for $500,000.

Lesson #2: Have product claims reviewed before you advertise. The FTC said in a press release that it had charged CVS with “making false and deceptive advertising claims that using its product would reduce the risk of colds and protect against catching colds in crowded places, such as schools, airplanes, offices, health clubs, theaters, or restaurants.” The FTC said that “the company had no evidence that the products could boost the immune system or prevent colds.”

Lesson #3: The FTC is cracking down on supplement advertising. “With orders against Airborne, Rite Aid, and the one proposed against CVS, manufacturers and retailers are on notice that they have to tell the truth about what dietary supplements can and cannot do,” the FTC said in its release on the CVS settlement.

Lesson #4: Do not stretch the truth. The FTC is taking a highly critical view of product claims and scientific evidence. The agency has sued Rite Aid’s supplier of Germ Defense, Improvita Health Products Inc., claiming that company with deceptive acts or practices and with making false advertisements.

Lesson #5: Avoid the flu — and advertising related to it. This fall, the public faces the dual threat of seasonal flu and the H1N1 virus. A company that advertises a defense against either is likely to receive a call from the FTC.

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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!

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A recent study by LegalMetrics, a litigation analysis firm, named the Southern and Middle Districts of Florida among the top five districts for speed to resolution in patent infringement cases.   Since Florida has not been known as a “rocket docket” in the past, these results may seem surprising.  However, for intellectual property litigation attorneys, the recognition that Florida offers a favorable forum for facilitating the resolution of cases in a timely manner is nothing new.

The Southern District (in yellow) and the Middle District (in green) cover all Florida’s major population centers.  A survey we performed of filings of intellectual property cases in popular federal districts including these Florida Districts reveals that, with the exception of the Eastern District of Virginia, filings of IP cases have trended downward in the last several years.  Of course, fewer cases filed mean more attention for filed cases from the federal judges assigned to those cases.

Decisions in IP cases issued in early 2009 further suggest IP owners receive favorable treatment from Florida district court judges.  Among these decisions were the following:

• In a trademark infringement case filed in the Southern District of Florida, district judge Daniel T. K. Hurley denied the defendant’s motion to dismiss finding that the plaintiff trademark licensee had standing to prosecute infringements even though it was not the trademark owner.  In the process, the court adopted a liberal interpretation of standing for Lanham Act claims favorable to plaintiffs. See Trump Plaza of the Palm Beaches v. Rosenthal, Case No. 08-80408 (Jun. 24, 2009) .
• In a patent infringement case filed in the Middle District of Florida, district judge Steven D. Merryday dismissed counterclaims for unjust enrichment as preempted by federal patent law. See Mayo Clinic of Jacksonville v. Alzheimer’s Institute of America, Inc., Case No. 8:05-cv-839 (Jun. 26, 2009).
• In a patent infringement case filed in the Southern District of Florida, district judge James I. Cohn denied the defendant’s motion to dismiss and held that the plaintiff had standing to sue for infringement based upon an agreement with the original inventor in England signed before the patents were ever filed in the United States. See Flexiteek Americas, Inc. v. Plasteak, Inc., Case No. 08-60996 (Jun. 14, 2009).

Other cases demonstrate a willingness among Florida district judges to find personal jurisdiction over defendants based upon very minimal contacts including activities on the Internet.  Recent decisions have indicated that Florida courts will follow liberal standards for jurisdiction where simply maintaining an interactive website accessible on the Internet from Florida will subject a defendant to personal jurisdiction in the Sunshine State.

The moral of this story: when considering where to file an infringement action, intellectual property owners, including owners of trademarks, copyrights and patents, as well as counsel for these owners, would be wise to consider filing in the Southern or Middle Districts of Florida.  Of course, IMHO, my firm Arnstein & Lehr LLP, with its vast Florida litigation resources and experience prosecuting infringements would be an excellent choice to partner with as knowledgeable counsel for such cases.

PR: wait… I: wait… L: wait… LD: wait… I: wait… wait… Rank: wait… Traffic: wait… Price: wait… C: wait…

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California Attorney General Edmund G. Brown Jr. recently joined with 32 other state attorneys general in announcing a landmark $7 million settlement with Airborne, Inc. that forces the company to stop advertisements that “dramatically misrepresented” its dietary supplements as cold remedies.

“Airborne dramatically misrepresented its products as cold remedies without any scientific evidence to back up its claims,” Attorney General Brown said. “Under this agreement, the company will stop advertisements that suggest that its products are a cure for the common cold.”

Airborne began selling its products as a cold remedy on the Internet around July 2000 and on television in 2004. In its advertisements, Airborne featured people suffering from cold and flu symptoms and made unsupported statements suggesting its products were a cure for the common cold. To read the news release, click here.

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