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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In a statement, commission chairman Jon Leibowitz said, “We expect more from a great American company than making dubious claims – not once, but twice – that its cereals improve children’s health. Next time, Kellogg needs to stop and think twice about the claims it’s making before rolling out a new ad campaign, so parents can make the best choices for their children.”

In a joint statement, Leibowitz and commissioner Julie  Brill used stronger language: “As a trusted, long-established company with a presence in millions of American homes, Kellogg must not shirk its responsibility to do the right thing when it advertises the food we feed our children.”

Kellog had a run-in with the FTC over its Frosted Mini-Wheats that resulted in the company’s admission that health claims made for the cereal were false and a settlement order in February 2009. Kellogg agreed not to claim “benefits to cognitive health, process, or function provided by any cereal or any morning food or snack food unless the claims were true and substantiated,” according to the statement on the Rice Krispies order.

Leibowitz and Brill said in their joint statement that even as Kellogg was pulling back on the Mini-Wheats claims, it must have been moving forward with health claims on the Krispies cereals.

“The company clearly has the means and ability to carefully test its children’s food products to determine if the products in fact provide health benefits for kids,” the commissioners said. “We are also confident that Kellogg has the wherewithal to carefully develop truthful and nonmisleading advertising about such health benefits.”

Kellogg responded with a statement saying that it stands behind the validity of product claims and research. “So we agreed to an order that covers those claims,” their statement said.

The expanded order now prohibits Kellogg from “making claims about any health benefit of any food unless the claims are backed by scientific evidence and not misleading.”

This is familiar ground for makers of nutritional supplements, but not so much for a manufacturer whose advertising icons include three guys in hats and a cuckoo bird. (Cocoa Puffs had the claim, too.) Kellogg, and General Mills whose Cheerios heart-health claims drew a warning letter from the Federal Drug Administration, are now learning what it’s like when you emblazon words like “immunity” and “antioxidants” on product packaging.

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Should there be a language standard in Google ads for supplements? Drug marketers may adopt rules given the close scrutiny that the FDA is giving search-generated ads for pharmaceuticals. The Interactive Advertising Bureau is asking the feds to endorse the use of standard formats online for drugs.

Why? Because seemingly harmless statements are incurring the FDA’s wrath. Case in point: A search for the pain medication Fentora generated this sponsored message from its maker, Cephalon: “Learn about treating breakthrough pain in patients with cancer.”

Harmless, right? No, said the FDA. According to a MediaPost report, the FDA deemed “such ad copy was deficient because it implied that all cancer patients with breakthrough pain could use Fentora.” The agency also said that the “implication was misleading because the drug is only indicated for people who can already tolerate around-the-click opioid therapy.”

The FDA warned a host of the world’s largest drugmakers that they too were running misleading ads. Unsure of how to act, the companies cut back on search-generated ads, with volume falling by about half. Now, the IAB wants a set of clear rules so that the drugmakers can resume online advertising without getting into trouble.

Standards may also help marketers of nutritional supplements. While drugmakers have a higher standard for publishing warnings and limitations on their products (see any Cialis ad), makers and marketers of nutraceuticals operate at their peril in making claims for ingredients. And sponsored links on Google could be one place they find trouble.

For example, a search on antioxidant produced this language in a sponsored link:

Get Healthy w/Natural Antioxidants
One Year Money Back Guarantee!”

Similarly, a search on glucosamine chondritin produced this ad language:

Drink Joint Juice and Leap More.
The 30-Day Joint Health Challenge!

How would the FDA or FTC view these claims getting healthy or jumping higher if they were made for drugs? The supplement industry may want an answer before agencies go on the offensive.

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This time, the news report is real. In an earlier blog, we identified News 13 and News 29 as faux-TV news Web sites that touted the health benefits of resveratrol and acai. Our search of public and other records linked them to a company in Hollywood, Florida, among other locations. We told readers to stay tuned for an update.CBS News -- the real network -- reported July 29 on what appears to be the same Hollywood-based company, FWM Laboratories, in a national broadcast and an accompanying Web story headlined, "Buyer Beware: Web Supplement Scams." Some of the Web site visuals in the TV report (such as the Resveratrol Ultra Web page) are the same we saw in our research. Some had prominent mentions of CBS News and its "60 Minutes" news show as sources of information about the benefits of resveratrol. That may have prompted the story.Kelly Cobiella

In its reporting, CBS discovered an “F” rating from the same regional Better Business Bureau and a multitude of Web sites that FWM uses, though it is not clear if the faux-TV stations were among them. Kelly Cobiella, a real reporter from CBS, found the company’s offices. She toured the sales and shipping departments, and had a sit-down with CEO Brian Weiss who looked, in our opinion, a little uncomfortable. He told Cobiella, “We’ve sold to million and a half customers since November. So in the overall picture, the number of complaints seems high, but it’s low when compared to the number of orders we’ve shipped out.”

The Web story follows with this: “In fact, FWM is one of the most complained-about companies in the nation. The Florida Attorney General is investigating the company and the Federal Trade Commission is looking into the marketing tactic they – and companies like them – use. News organizations including CBS have tried to get FWM and others to stop misusing their reports to sell products.”

Signature statements from Walter Cronkite and Paul Harvey come to mind, but let’s think about consumers. One FWM customer told CBS News that he signed up for what he thought was one 99-cent sample bottle, but received and was billed for two more at $87 each.

Do billing practices like these reflect well on the industry as a whole? If not, what can be done so that other sellers of resveratrol and acai are not also labeled as scammers?

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As many of our readers know, I devote a substantial portion of my practice to representing dietary supplement companies in regulatory matters, transactions and litigation, including intellectual property disputes and licensing.  That is one of the reasons why I started the Nutritional and Dietary Supplement Law Blog almost four years ago, and it’s why I chose to bring my practice to Arnstein & Lehr.

Arnstein has an excellent Health Care Practice Group and I hope to contribute my knowledge of supplement regulatory issues to assist existing and new firm clients.  Furthermore, my specialty in intellectual property will help me support and grow the Intellectual Property Practice Group at the firm.

I am especially excited to be working with veteran trademark lawyer Judy Grubner of Arnstein’s Chicago Office.  Judy has over thirty years experience registering trademarks for some of the biggest brands around.  I am so fortunate to have Judy as a resource to help my supplement clients manage and grow their trademark portfolios and protect their brands.

Arnstein & Lehr was founded in 1893 and is currently home to over 150 lawyers practicing in Chicago, Wisconsin, Florida and beyond.  I am pleased to have the opportunity to offer the depth and breadth of resources of this great firm to my wonderful clients who have supported me over the years.

I encourge all our readers to spend a few minutes at the Arnstein & Lehr website and get to know the firm and its capabilities.  Please contact me if Arnstein & Lehr can help you or your business in any way.  You can find all my contact information on my bio page here.  I can’t wait to hear from you!

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The Food & Drug Administration issued on May 1 a consumer warning to stop using Hydroxycut, the heavily marketed weight-loss product. The agency said that “some Hydroxycut products are associated with a number of serious liver injuries” and announced that the maker was recalling all products.

Did the FDA properly react? The warning cited 23 serious health problems, including jaundice, liver damage, seizures and cardiovascular disorders. One person has died from liver failure since 2002 when the Center for Food Safety and Applied Nutrition first received reports about liver damage associated with intake of Hydroxycut.

Some people — for reasons not totally understood — had adverse reactions to Hydroxycut, according to a research report cited in the FDA warning. Sometimes the individuals required serious treatment for liver damage. Other times, the people regained normal health when they stopped taking the product.

Until 2004, Hydroxycut contained ephedra, a substance that the FDA banned after a study found more than 16,000 adverse events associated with its use in dietary supplements. According to a recent label, the main ingredients in Hydroxycut are now the minerals calcium, chromium and potassium, plus what the company calls Hydroxagen Plus and HydroxyTea. The former contains leaf and rind extracts and the latter is a combination of tea and ginger extracts.

None are banned substances. And the  health hazard evaluation board acknowledged in its report that it “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.”

The board concluded, “Three lines of evidence derived from multiple disparate sources suggest it is very likely that exposure to Hydroxycut can cause idiosyncratic hepatotoxicity.”

Some definitions are in order. According to a 2007 article in Toxicological Sciences, “Idiosyncratic hepatotoxicity is a rare and unpredictable event of liver injury affecting generally less than 1 in 10,000 patients treated with certain drugs. However, it is a serious clinical problem as it accounts for 10% of all drug-induced liver failure cases.”

And citing a study published in May 2005 in the Nature Reviews Drug Discovery, the article said, “Idiosyncratic hepatotoxicities are currently the main cause for Food and Drug Administration-mandated warnings, restrictions of use or even withdrawals of drugs from the market.”

So, the FDA puts great weight on idiosyncratic hepatoxicity even though it is uncommon and difficult to predict in a population. Given the level of uncertainty, did the FDA have other options? After conducting a risk-benefit analysis, could the agency have told the makers of Hydroxycut to add a warning to immediately discontinue use and seek medical attention if certain symptoms present themselves? Why did an average of three cases per year — none this year and only three last year — justify a ban and recall?

Here’s a clue from the report, which references the Center for Food Safety and Applied Nutrition as CFSAN:  “In discussions in March and April of 2009 with hepatologists Tse-Ling Fong, M.D. of the University of Southern California and William Lee, M.D. of the University of Texas Southwestern Medical Center, CFSAN has become aware of these physicians’ case series of patients with severe liver disease associated with the use of Hydroxycut. Two cases from this series, representing additional cases to the ones reported to CFSAN, underwent liver transplantation following acute liver failure.”

Were the doctors two of the three sources? And were their case series the underlying reason for such swift and final FDA action? The answers are not here, but they are needed.

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Let the grant writing begin. The National Institutes for Health has been among the big winners in the American Recovery Act, a.k.a. the economic stimulus package. Universities are lining up for $8.2 billion in research grants on a wide range of subjects. Almost any nutrition supplement company interested in conducting research in support of a product should be able to establish a relationship with a university researcher. The trick is knowing which grants to apply for and how.

The grants are alphabetical categories ( F, K, P, R, S, T and U) that cover everything from fixing up labs to funding clinical research. And as you might expect, no two NIH institutes support the same funding mechanisms. That’s where the fun — and opportunity — begins. Nutritional companies that partner with an adept research grant writer can find the money. Among the prime places to look:

• National Institute on Aging (NIA)
• National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS)
• National Heart, Lung and Blood Institute (NHLBI)
• National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)

There are also grants that target minorities underrepresented in the research sciences and something called the Interactive Research Project Grant.

Companies could spend a lot of time trying to figure out which grants best fit their needs, but the best approach is to find a smart university partner. Science departments are mobilizing for the cash, which will help pay salaries and overhead, and could bring them prestige. The corporate partner that brings an opportunity and resources should be able to generate interest from a dean or department chair.

Keep in mind that much of the federal money may go to existing research proposals that got high marks from federal reviewers but were shelved due to lack of funds. Still, opportunities abound for those that move quickly.

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Two contributors to this blog, Vincent Annunziata and Hugo Ottolenghi, are participating in Nutracon, March 5-7. They will be at the CANI exhibit on Friday and Saturday from noon to 2 p.m. CANI is located in Hall A, Booth 242.

Annunziata and Ottolenghi will also be at SupplyExpo and Natural Products Expo West, which are occurring at the same time in Anaheim, Calif.

Annunziata and Ottolenghi are also members of the NutriCompliance team. Read more about them in the biography section and contact them through the Web site.

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Regulators said the beverage does not have enough nutrients to justify the use of the word “plus” in its name. According to the agency, foods labeled “plus” must have at least 10 percent more nutrients than comparable products. Additionally, the FDA said it is inappropriate to add extra nutrients to “snack foods such as carbonated beverages.” To read the complete warning letter click here .

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The FTC also announced a new Web site about bogus cancer cures. The site – www.ftc.gov/curious – tells consumers how to spot and report bogus claims they see online, and urges people with cancer to talk to their treatment team about any products they’d like to try.
The site features a video and includes a list of resources on cancer treatments from a variety of agencies within the federal government. Information is provided in English and Spanish.

The cases announced today began through an Internet surf conducted by the FTC, the U.S. Food and Drug Administration (FDA), and Competition Bureau Canada in June 2007. Following the surf, the FTC sent warning letters via e-mail to 112 Web sites between August 2007 and January 2008. Of these, nearly 30 percent either closed their sites or removed the problematic cancer treatment claims. The remainder were reviewed to determine whether a law enforcement action was warranted or whether they should be referred to the FDA or the Competition Bureau.

To read the press release, click here.

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