Following up on a post from June 30, the question of consumer confidence in nutritional supplements arises again. The Times-Herald reports that many supplements have quality problems.  No one knows just how many of 40,000 products underdeliver on the goods listed their labels and over-deliver on unlisted, harmful ingredients and contaminants. “I believe that the problem is narrow, that the well-established and reputable brands deserve their reputations,” Michael McGuffin, president of the American Herbal Products Association, tells the paper that serves the Hudson Valley of New York.

The article then reels off test results that indicate a much broader problem:  “In ConsumerLab.com tests, six out of nine chondroitin supplements failed testing in April 2007. One had only 8 percent of what it claimed to contain, and one ‘maximum strength’ product had none.”

How big will the elephant become before the people in the room acknowledge its presence? And who will act first: manufacturers, regulators, consumers, Congress, a state attorney general, or a sharp civil attorney? And which company will be hounded out of existence as an example to others in the industry?

Anne Hart has lots of questions about the quality and safety of nutritional supplements, 19 questions to be exact. They revolve around product integrity, contamination, mislabeling (think sibutramine), FDA oversight and so on.  A nutrition columnist for Examiner.com, Ms. Hart has several ideas for matching products to their labels,  all of which create more questions about the testing of every pill, powder, gel and liquid that could be considered a nutritional supplement.

The basic premise of her column is that a lab — probably a lot of labs — should test each nutritional supplement to see if it contains what the label says. The test results should be made available free of charge to consumers whether they are buying online, in a store or from a friend. Who owns the labs and who pays for all those assays and the like? And what entity maintains the databases that must constantly be updated?

Ms. Hart would like the nutrition supplement industry to underwrite the testing costs, but that poses an ethical problem: Just how independent and trustworthy can the labs be if their clients are the  manufacturers? For the answer, look at the uneven history of research firms on Wall Street. The Council for Responsible Nutrition is off the list, too, says Ms. Hart. We can rule out the FDA because it does not have the funding and cannot tax the manufacturers to pay the costs.  Universities have lots of labs and student researchers, but not the money to conduct tests.

“What about forming a group of consumers that would watch the government agency, the independent testing labs, and the manufacturers?” asks Ms. Hart? The idea may be laudable but it is not realistic. America’s social and economic structure does not have a place for such an entity unless it is underwritten by a foundation. The closest model is the Insurance Institute for Highway Safety. It tests how well vehicles fare in crashes, but insurance companies — not consumers — pay for the publicly available research.

Is there a solution that gives consumers peace of mind that what they buy is what they get?

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.

The Nutritional and Dietary Supplement Law Blog is pleased as punch to announce that Joel B. Rothman, your faithful editor and publisher, has joined the West Palm Beach office of Arnstein & Lehr LLP as a partner.

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!

In the days following the FDA warning on the dangers of taking Hydroxycut and the manufacturer’s recall, the reaction has been more sliced than divided. There were the oft-seen reactions: NaturalNews headlined its commentary, “FDA Floats Hydroxycut Scare to Discredit Yet Another Supplement Company.”  The personal injury law firm of Onder Shelton O’Leary & Peterson issued a press release that called for stricter controls regarding both the safety and weight loss claims of supplements like Hydroxycut.

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.

Here is some good advice I received in an email courtesy of Greenberg Traurig partner James R. Prochnow who allowed us to reprint this here.  The advice came in the context of potential reaction from the article by David Epstein and George Dohrmann in Sports Illustrated entitled “What You Don’t Know Might Kill You.”

James’ suggestions are excellent ones for supplement companies to consider at any time, not just when scrutiny is heightened.  Here are James’ suggestions:

We strongly recommend the following based upon the reading of this article and the likelihood of more consumer lawsuits, including class actions based upon false or deceptive advertising, recent developments relating to product recalls, and the ever-increasing regulatory and quasi-regulatory scrutiny of web site claims:

1. You should review, or you should have someone review, your insurance policy or policies to make sure that you are covered with respect to losses or claims that are most likely to be asserted by others or by you (for coverage by your own insurer) that arise from some alleged injury or damage from (i) the ingestion by a consumer of your dietary supplement or a supplement that you handle in some way or (ii) a product recall. This review should definitely include (1) preparation of a list of possible claims and circumstances and (2) a follow-up call or meeting with your insurance agent and a writing from an authorized representative of your insurance carrier that the coverage you desire is, in fact, provided by your policy.
2. You should again consider getting bids for contracts for the carrying out of carefully designed scientific studies to confirm or develop your major advertising and labeling claims.
3. You should make sure that the claims being made for your product, if based upon one or more scientific studies, are consistent with that scientific study or those studies.

Good advice.  I thought it was worth passing along.

There was a ton of buzz this past week about the article by David Epstein and George Dohrmann in Sports Illustrated entitled “What You Don’t Know Might Kill You.” Even my Dad emailed it to me.

The criticism of supplements by SI is flawed in so many respects. Steve Mister of CRN pointed out many of the mistakes made by SI in his response at the CRN website here. I won’t repeat all his observations here. Please go to CRN’s website and read them yourself.

We read the article around here and concluded it was just more old news.   Since articles about performing enhancing drug (PED) are tired, sportswriters appear to be looking for the next big story. From the SI article it looks like they should go back to writing about PEDs. Athletes and their trainers know what works and what doesn’t. What’s banned and what’s not.

The article lacked a forward-looking angle, such as changing FDA rules or requiring manufacturers to test their products at independent labs.

Also, there was nothing about the value of traditional supplement use.  Scientific evidence supporting the use of dietary supplements to reduce the risk of disease is growing.

Meanwhile, over 70% of doctors now recommend dietary supplements to their patients.  Probably most of the SI reporters and editors take a multivitamin daily, but no mention of that in the article.

This month’s Nutritional Outlook magazine features an article by your favorite Nutritional and Dietary Supplement Law blog editor/publisher Joel Rothman.  Entitled “Playing It Safe: Marketers can protect themselves against product adulteration and recalls,” the article provides several valuable tips for supplement marketing companies looking to avoid legal and regulatory problems in today’s challenging environment.

Here is the Cliff’s Notes version:

• Implement cGMPs with custom SOPs and testing
• Negotiate solid contracts with protections
• Consider recall insurance

And remember, NutriCompliance is here to help.  Many thanks to CANI for the great editorial opportunity.

Get ready for the not-so-kind-and-gentle FDA when it comes to food safety. The agency took abuse from politicians and consumer advocates over its handling of peanut and pistachio contamination earlier this year. Possibly to avoid a third hit, the agency moved swiftly and without warning on May 7 when it sent U.S. marshals into a warehouse of Memphis-based American Mercantile to seize $1.5 million in food ingredients.

The FDA found evidence in March of extensive rodent and insect infestation throughout the company’s warehouse, the agency said in a news release. American Mercantile did not clean up the mess, the agency said, so it obtained a court order to send federal agents to the company’s warehouse. They hauled away food products including sarsaparilla, spearmint leaves, cornstarch, sweet orange peels powder, licorice powder, sassafras and salt.

“FDA will not tolerate a company’s failure to adequately control and prevent filth in its facility,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, said in the release. “The FDA is prepared to use whatever legal means are necessary and appropriate to keep potentially contaminated products out of the marketplace.

Tough action matched the words. Functional Ingredients reports that the FDA did not issue a warning letter to American Mercantile before the raid.

The door-kicking has rattled some in the ingredients industry. “If there is anything to be learned from this, it’s that this is a very visible example of a system that needs improvement. Better communication is needed from FDA, third-party certifiers and the National Organic Program and vice-versa,” says Marty Mesh, executive director of Quality Certification Services told Functional Ingredients. QCS was due to re-inspect American Mercantile for organic certification, according to the article.

“The food and supplements industry can expect a lot more of this,” says Loren Israelsen, executive director of the supplements trade group United Natural Products Alliance, told the publication. “This is the new FDA, so wake up everybody.”

Now that the FDA has everyone’s attention, what are the best courses of action?

• Take health inspections seriously. Ignore an FDA or state agency evaluation and armed men may come through your door.
• Keep warehouses and manufacturing facilities squeaky clean. Check vendors and demand documentation, not assurances, that they are following certified good manufacturing practices.
• Communicate. Tell customers, regulators and certification agencies what steps you are taking to make sure that your food ingredients are uncontaminated. Post documents online that show your company and its vendors passed inspections.
• Trust, but verify, as the Russian saying goes. American Mercantile says on its Web site that its manufacturing plant is GMP/FDA and pharmaceutical compliant, but Functional Ingredient could find no evidence to support those claims.

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.