Joel B. Rothman

West Palm Beach Partner Joel B. Rothman was a guest lecturer on April 12 at Northwestern University’s Medill School of Journalism, Media and Integrated Marketing Communications masters degree program. Mr. Rothman spoke to two sections of a graduate class entitled “Law, Policy & Media” and addressed topics on advertising law, claim substantiation, unfair/deceptive practices, and intellectual property issues. Northwestern’s Medill program in Integrated Marketing Communications is an innovative program whose graduates occupy positions at advertising and marketing firms worldwide, as well as in marketing departments at Fortune 500 companies and start-up businesses.

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Judith L. Grubner

When I lived in the Chicago suburb of Oak Park, Illinois, if the wind was blowing from the right quarter you could smell the aroma of LEMONHEAD® and RED HOTS® candy from the Ferrara Pan Candy Co. factory in nearby Forest Park. Ferrara Pan, founded in 1908, is also the manufacturer of other well-known candies such as ATOMIC FIREBALL® cinnamon candy, JAW BUSTERS® jawbreakers and BOSTON BAKED BEANS candy coated peanuts. In June 2011, Ferrara Pan added PEANUTHEAD® candy to its line of products and obtained a federal registration for that trademark in September 2011. Ferrara Pan used what it described as a photograph of a BOSTON BAKED BEANS candy package that also bore the PEANUTHEAD mark as its specimen of use to get that registration.

While the PEANUTHEAD application was still pending in the U.S. Patent and Trademark Office, Ferrara Pan filed a notice of opposition in the Trademark Trial and Appeal Board against an application to register NUTHEADS, owned by Nut Heads Chocolate Factory, Inc., of Perham, Minnesota. After the PEANUTHEAD mark registered, Ferrara Pan also filed a notice of opposition against Nut Heads’ application to register NUTHEADS CHOCOLATE FACTORY. In those opposition proceedings, Ferrara Pan made statements that Nut Heads’ use and/or registration of the NUTHEADS and NUTHEADS CHOCOLATE FACTORY marks are likely to cause confusion because of their resemblance to the PEANUTHEAD mark and other Ferrara Pan marks that contain “HEAD.” Ferrara Pan also responded to a written question in the NUT HEADS opposition that “use and/or registration of NUTHEADS for the goods identified in [the NUTHEADS application] is a violation of [Ferrara Pan’s] trademark rights.”

Those statements, which are commonly made in opposition proceedings, have come back to bite Ferrara Pan. In a Complaint filed in U.S. District Court in Minnesota on February 10, 2012, Nut Heads and its parent company KLN Enterprises, Inc. have asked the judge to declare that the NUTHEADS and NUTHEADS CHOCOLATE FACTORY marks do not infringe Ferrara’s Pan’s PEANUTHEAD or other marks, to allow them to continue selling their products using those marks, to bar Ferrara Pan from suing them for trademark infringement, and to order the TTAB to dismiss the pending oppositions. Nut Heads states in the Complaint that it is currently selling chocolate covered licorice, pretzels, potato chips, and caramel-corn, glazed nut-clusters and holiday gift tins in connection with its marks.

Nut Heads contends that Ferrara Pan “has not offered [KLN and Nut Heads] evidence showing that [Ferrara Pan] has in fact used the mark PEANUTHEAD as of June 1, 2011.” In support, it points to the absence of any PEANUTHEAD products on Ferrara Pan’s web site as of December 12, 2011. However, Nut Heads does not go so far as to claim that Ferrara Pan obtained its PEANUTHEAD registration fraudulently or that the PEANUTHEAD mark and registration are invalid because the mark was not actually in use in U.S. commerce on June 1, 2011, as Ferrara Pan represented to the USPTO. Nor did Nut Heads include any allegations of fraud or invalidity in its answer to Ferrara Pan’s opposition to the NUTHEADS application.

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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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On October 4, 2011, Real Mex Restaurants and Chef Solutions Holdings filed for bankruptcy relief in Delaware under Chapter 11 of the Bankruptcy Code. The very next day, Friendly’s Ice Cream, known for its old-style East Coast ice cream parlors and restaurants, also filed for protection from its creditors under Chapter 11.

These three companies run the gamut in the food industry. Real Mex Restaurants is one of the largest full service, casual dining Mexican restaurant chains in the United States. In 2006, an affiliate of Sun Capital Partners, based in Boca Raton Florida, purchased Real Mex Restaurants for $359 million. An affiliate of Sun Capital also invested in Friendly’s, the owner and franchiser of about 490 restaurants and ice cream parlors along the East Coast. Chef Solutions, on the other hand, provides prepared foods under brand names such as Orval Kent, Pennant, Yoder’s and La Francaise.

The filing of any one of these Chapter 11 Cases triggers concern among suppliers and customers as to whether a supplier should continue to ship goods to the Chapter 11 debtor and on what terms. They are also concerned with whether the debtor will secure financing to continue to produce goods for their respective customers.

Therefore, suppliers and customers of a Chapter 11 debtor should take immediate action to protect their rights upon learning of a bankruptcy filing. For example, if you are one of the critical vendors of a company in bankruptcy, you may be entitled to negotiate a deal where you are paid a portion of your pre-petition claims in exchange for agreeing to certain credit terms on a going forward basis. You also may be entitled to a priority claim for goods shipped and delivered within twenty days of the filing date. Finally, if you received any payments within ninety days of the filing of the Chapter 11 Case, you may receive a demand letter, or possibly a complaint, requiring that you return all payments received within that time period.

These preference demands are subject to many defenses often reducing or eliminating any potential exposure you may have. Therefore, it is critical at the outset of a Chapter 11 Case to understand your rights, preserve any claim you may have to a distribution and protect yourself against a lawsuit for payments you received within ninety days of the bankruptcy filing.

With the present economic conditions and rising food prices, sales have declined greatly in the food and restaurant industry. Many more middle class households are deciding that it is more economical to eat at home. When you mix in above market rents you have a recipe for disaster. While we expect the wave of bankruptcy filings to continue, it is important to stay vigilant in monitoring the companies for whom you do business and protect, to the best of your ability, your right to recover any amounts due.

Many of these issues can be addressed in advance of the bankruptcy filing when you notice that the days from invoice to payment have increased along with the total outstanding receivables. It is important to stay ahead of the game; otherwise, you may find that you have bitten off more than you can chew.

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The FBN Blog is sponsored by my firm, Arnstein & Lehr, LLP.  This change will bring in fresh perspectives from members of the new Food, Beverage & Nutrition Law Practice Group and provide our readers with great information they can use in their business beyond just dietary supplements. 

In the coming weeks and months you will be introduced to my partners and associates who represent a range of manufacturers, distributors and sellers of food, beverage and nutritional products.  In the process, the blog will expand its focus to address the challenges food, beverage and nutrition industry companies face in the areas we practice in including:

• Labor and Employment
• Intellectual Property
• Corporate Finance, Securities and Mergers & Acquisitions
• Bankruptcy and Creditors’ Rights
• Regulatory and Governmental Affairs

We hope you like the new look.  We expect you will enjoy reading what our blog offers in future and that you continue to find the information and viewpoints here valuable to your business.  Thank you for your support now and in the future!

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Earlier this year, President Obama signed the Food Safety Modernization Act (FMSA), which amends various portions of the United States Code relating to FDA’s powers to detain and regulate domestic and imported food products.  While the law was primarily drafted to grant the FDA some preventive measures to protect the American public from recent food scares (e.g., tainted peanut butter and eggs in 2009 and 2010 respectively), the language of the act will also have an effect on the dietary supplement industry.  However, the question is whether the FMSA, which will become effective on July 3, 2011, will have a material impact on the way most dietary supplement firms run their business.

Generally, the FMSA grants the FDA the authority to detain food products that it reasonably believes is adulterated for up to 30 days, and it also requires food importers to disclose whether their products were denied entrance in other countries.  While FDA’s expanded authority to detain foods is certainly material to the dietary supplement industry, the second rule is rather periphery unless a dietary supplement firm relies on imported food ingredients.  In addition to these two broader rules, the FMSA also amends some language in the Food, Drug & Cosmetic Act (FDCA) governing new dietary ingredients.  More specifically, the new law requires the FDA to notify the DEA whenever an application for a new dietary ingredient lacks sufficient substantiation proving that the ingredient is free from steroids or steroid analogs.

First, it is important to note that the FMSA lessens the burden of proof required by FDA to invoke its power under 21 U.S.C. 334(h)(1)(A) to detain adulterated food products from credible evidence to reasonable belief.  Whereas Black’s Law Dictionary defines the “credible evidence” standard as “evidence that is worthy of belief,” it also defines the “reasonable belief” standard as “to believe a given fact or combination of facts under circumstances in which a reasonable person would believe.”  Further, the “credible evidence” standard is generally considered a relatively easy burden to prove compared to other standards; however, under the FMSA, 21 U.S.C. 334(h)(1)(A) is abrogated to include an even lesser burden of proof standard.  Thus, if the FDA reasonably believes a given dietary supplement is adulterated—a catchall term that includes violations of the FDCA that range from relatively harmless violations such as improper structure and function claims to more egregious infractions such as the presence of harmful contaminants—the dietary supplement in question would be subject to federal detention for up to 30 days.

Second, section 113 of the FMSA also amends 21 U.S.C. 350b by adding the following language:

If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. (Emphasis added)

This provision is clearly designed to prevent the market and sale of unlawful steroid and steroid-analogs under the guise of dietary supplements.  While the language is putatively consistent with the Dietary Supplement Health & Education Act of 1994 (DSHEA) insofar that the burden rests with FDA in proving that a given ingredient does not comport with the law, it seems rather presumptuous to immediately conclude that the absence of documentation showing a dietary ingredient does not contain steroids or steroid analogs means it is, or contains, the steroid or steroid analog.

Nevertheless, the addition of these two new rules under the FMSA will likely affect the way dietary supplement firms operate their businesses, but it is unlikely that compliance with the FMSA will present the same challenges as CGMP compliance.  Yet, dietary supplement firms should be acutely conscious of the detention provision because the FDA is legally permitted to take proactive steps to detain products by satisfying a lesser burden (i.e., it is easier for the FDA to detain potentially adulterated products).  Coupled with the possibility of criminal sanctions under the Park Doctrine, dietary supplement firms should navigate the changing regulatory landscape cautiously and adopt super-adequate protocols that comport or exceed the requirements set forth in 21 C.F.R. 110 and 111.  Similarly, firms engaged in the manufacture, distribution, market, or sale of new dietary ingredients should take deliberate steps to dispel any suspicion that an ingredient is adulterated with steroid or steroid-analogs by submitting the necessary documentation.

Shafiel A. Karim earned a B.A. from California State University, Fullerton and an M.A. from California State University, Long Beach.  He is currently a J.D./M.B.A. candidate at Southwestern University School of Law and the Peter F. Drucker and Masatoshi Ito School of Management at Claremont Graduate University.

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As FDA continues to inspect dietary supplement manufacturers under the new CGMP framework, it is clear that many manufacturers share similar deficiencies.  Recent FDA warning letters show that many manufacturers are still struggling with structure function claims, the required pre- and post-production qualitative and quantitative testing requirements, and strong quality control units that have the necessary authority and resources needed to comport with CGMPs.  (See, e.g., here, here, here, here, here, and here.)  When coupled with recent administrative guidance suggesting FDA may resort to reprimanding non-complying firms under the Park Doctrine, which imposes strict criminal liability for non-compliance with CGMPs, it is imperative that dietary supplement firms understand the potential consequences arising from serious CGMP violations.

Indeed, last year FDA sent a letter to Senator Charles Grassley (R-IA) explaining its intention to reintroduce the possibility of imposing criminal charges for misdemeanor violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”) under the Parks Doctrine.  The Park Doctrine imposes strict liability, which means that the violating firm’s senior management need not have intent or knowledge of the violations to be found guilty.  Therefore, given FDA’s publicly stated intention of imposing harsher punishments for CGMP non-compliance, are future violations similar to those recorded thus far likely to result in criminal sanctions under the Park Doctrine?

The Park Doctrine is derived from United States v. Park, 421 U.S. 628 (1975), a landmark case decided by the Supreme Court.  In Parks, the president of Acme Markets, Inc., a large national food retailer, was convicted of violating sections of FFDCA for failing to sufficiently rectify unsanitary conditions at some of Acme’s warehouses, and for allowing adulterated food to be distributed in interstate commerce.  The Court reasoned that “[t]he requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the public has a right to expect of those who voluntarily assume positions of authority in business enterprises whose services and products affect the health and well-being of the public that supports them.” Parks, 421 U.S. at 672.  A dietary supplement is considered adulterated if it is prepared, packed or held in conditions that do not comply with CGMPs, or if it contain poisonous or unsafe ingredients.  21 U.S.C.A. 342.

While FDA has enumerated several “serious” violations of FFDCA during routine CGMP audits, the severity of the violations found do not necessarily pose a serious public health risk as seen in Parks.  For example, FDA’s recent warning letter to Gaspari Nutrition cites several deficiencies in the company’s customer complaint recording procedures.  While the absence of customer complaint recordation procedures may (substantially) delay the recall of an adulterated dietary supplement product that poses a public health risk, it is not aconduct that is necessarily an imminent public health risk.

In fact, the majority of violations found in dietary supplement firms—as recorded in FDA’s published warning letters—stem from a lack of documentation, validation, or pre- and post-production testing.  In Parks, however, the violations were more obviously deleterious; FDA inspectors found chronic rodent infestations in some of Acme’s warehouses.  However, this is not to say that deficiencies in documentation, validation, and testing cannot result in the manufacture or distribution of dietary supplements that pose a public health risk.  On the contrary, such deficiencies may simply be telltale indicators of more substantive public health risks.  For example, if a dietary supplement firm cannot confirm the identity or purity of an ingredient through documentation, it is logically plausible to conclude that the dietary supplement may contain ingredients that are injurious to public health.

Dietary supplements that are processed in operations that do not comport with CGMPs are more likely to be contaminated by virtue of the fact that such operations lack the necessary infrastructure and procedural controls necessary to prevent cross-contamination and adulteration.  Smaller dietary supplement firms are less likely to have made the necessary investments in air handling and water purification systems, both of which are potential sources of adulteration.  If a cleaning procedure is not validated though quantitative testing, how can the manufacturer verify that the equipment has been sufficiently cleaned to prevent potential microbial growth or product cross-contamination?  To be sure, firms that lack validated operating procedures risk improperly cleaning equipment and facilities without sufficiently eliminating the potential for adulteration.

Despite these deficiencies, anecdotal consensus suggests that any future Parks Doctrine enforcement will stem from gross violations of FFDCA and CGMPs that are so pervasive that they pose a substantial and imminent risk to public health.  And, using Parks’ factual circumstances as a guide, habitual or repeated violations will likely be a prerequisite for a Parks Doctrine prosecution.  From a procedural vantage, if FDA intends to pursue criminal sanctions under the Park Doctrine, it must notify its Office of Criminal Investigations accordingly, which is then required to conduct further due diligence.  Unfortunately, FDA has not supplied a bright-line rule articulating what kinds of violations will warrant criminal sanctions.  Instead, firms are left with a series of factors, which includes repeated violations and illegal conduct, inter alia.

Although the likelihood of FDA imposing criminal sanctions to owners and senior decision-makers of dietary supplement firms for minor violations of CGMPs is unlikely, repeated violations that engender public health risks will certainly be candidates for the draconian consequences that arise from the Parks Doctrine.  Accordingly, it is in the dietary supplement industry’s best interest to adopt super-adequate quality control and quality assurance protocols.  Instead of waiting for FDA’s inexorable audit, dietary supplement firms should be conducting regular internal audits to ensure compliance with CGMPs and other relevant regulatory rules.  Such measures will engender good will with consumers of dietary supplement products as well as government agencies.

Shafiel A. Karim earned a B.A. from California State University, Fullerton and an M.A. from California State University, Long Beach.  He is currently a J.D./M.B.A. candidate at Southwestern University School of Law and the Peter F. Drucker and Masatoshi Ito School of Management at Claremont Graduate University.

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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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