The Nutrition Business Journal Blog

Industry Responds to Press Coverage Of ConsumerLab’s Animal Supplement Test

Carlotta Mast — Tue, 14 Jul 2009 17:55:16 +0000

Joint-related products represent the most popular supplements for dogs and horses, and yet a new analysis from ConsumerLab.com found that many of these products may not be providing the benefits they could or, worse yet, may actually be harmful to the four-legged creatures who consume them. At least that’s the story, as reported by the Associated Press, that began showing up in newspapers and on news Websites around the United States on July 9, 2009. Although they haven’t disputed the findings from ConsumerLab’s most recent test of animal joint supplements, some in the industry remain frustrated with how the media, particularly the Associated Press, has reported on this and other supplement-related stories in recent months—and they want to set the record straight.

“The [July 9 Associated Press] article is an example of how the industry has been portrayed very unfairly by selecting specific snippets of conversations which support a preconceived premise that is both incomplete and very misleading given the efforts of the majority of the industry,” Bill Bookout, president of the National Animal Supplement Council, told Nutrition Business Journal.

In ConsumerLab’s test, four of the six joint supplements for animals analyzed by the independent, for-profit testing agency lacked the amounts of glucosamine or chondroitin indicated on their labels or contained lead, most likely due to glucosamine sourcing. ConsumerLab also released the results from its most recent test of human joint supplements, which found that five out of the 21 brands tested did not contain the promised amount of chondroitin or failed other quality measures.

In her July 10 story, the Associated Press’s medical writer Marilynn Marchione quoted Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), as saying that quality problems have been associated with supplements, although many companies do a good job. Blumenthal was also quoted as saying that dogs and cats are unable to give their subjective assessments of a supplement’s efficacy, and that owners want to believe that the supplements they pay for are having beneficial effects on their pets.

“These statements were pulled from an approximately 45-minute phone interview that Marchione conducted with Blumenthal on June 24, and many topics of that conversation and qualifications that Blumenthal provided were not included,” ABC wrote in a July 10 advisory to its members about Marchione’s article. “For instance, Blumenthal discussed several companies that are conducting legitimate research on the benefits of supplements on companion animals (dogs, cats, horses), but these were not mentioned in the article.” Marchione has written other Associated Press articles in recent weeks that have been critical of—and many in the industry say have been biased against—dietary supplements.

In its own test of animal supplements conducted in April, NASC found that 28% of the 87 brands tested did not contain what was claimed on their labels. NASC uses this information to help its members with quality control—which is a top priority for NASC and its members, which represent about 90% of the animal supplement companies operating in the United States today.

Bookout was also quoted in Marchione’s July 9 article, and he said NASC is working on a response now. As Bookout said he explained to Marchione, there are many challenges associated with supplement testing and it is important to understand that “testing is simply a snapshot in time.” This information was not included in the Associated Press article, nor were any details about the programs and initiatives NASC has put in place to help safeguard the quality of animal supplement products.

Unlike human supplements, animal supplements do not fall under the regulatory umbrella of the Dietary Supplement Health and Education Act (DSHEA), and therefore animal supplement companies are not required to adhere to the new Good Manufacturing Practice (GMP) rules created for human dietary supplements. To help ensure animal supplement quality and create a system for self regulation within the animal supplement industry, NASC established its own GMP quality standards to which each of its approximately 100 member companies must adhere. The NASC is also focused on certifying raw material providers as quality suppliers to the animal supplement industry as an added effort to ensure quality. “You cannot have a quality outcome without starting with quality ingredients,” Bookout said.

Such efforts are crucial to the future of the animal supplement industry, because, as Todd Henderson, DVM, president and founder of supplement manufacturer Nutramax Laboratories, told NBJ, quality problems can arise on both the animal and human sides of the supplement business—and these can be very problematic for the companies involved and the industry at large. According to Henderson, Nutramax Lab’s Cosequin brand, which was launched in the early 1990s as the first glucosamine/chondroitin combination product line for animals, was included in and passed ConsumerLab’s analysis of animal joint supplements.

Nutramax Labs is not a member of NASC, but Henderson said the company is dedicated to quality and science. In fact, according to Henderson, an inspection by the U.S. Food and Drug Administration showed that Nutramax Lab’s manufacturing facility operates at the level of pharmaceutical GMPs, which go beyond the requirements established for human supplement manufacturers under DSHEA and for animal supplement manufacturers under NASC’s member rules.

This commitment to quality is helping the company maintain double-digit growth for its animal supplement products, even in the current recession, Henderson said. “The economy has affected everyone, but it has affected science-based, quality products less because the consumer realizes that there is value to the quality and safety and effects that they see from these products.”

NBJ’s August issue will be devoted to the U.S. animal nutrition industry and will include features about the current regulatory status of animal supplements and the work of NASC and others to safeguard the quality of the industry’s products. To order a copy of the issue, subscribe to NBJ or download a free 32-page sample issue, go to www.nutritionbusinessjournal.com.

Related articles:

Joint, Omega-3 and Other Supplements Prove Popular for Bowser and Fluffy

Mineral Premix Problem Triggers Voluntary Recall of Nutro Cat Food

Where’s the Balance? SI Continues Attack on Supplements

Michigan Man Could Get 25 Years in Prison for Illegal Supplement Claims

Carlotta Mast — Tue, 07 Jul 2009 16:19:48 +0000

I returned to work from a nice holiday weekend yesterday to find a press release from the U.S. Department of Justice proving that some people are, well, just plain stupid.

The person in question is Tony T. Pham, owner of the dietary supplement company Techmedica Health Inc. in Grand Rapids, Michigan. The press release was announcing that Pham had pleaded guilty in federal court on July 6 to fraudulently marketing supplements via the Internet with illegal claims that the products could prevent, treat or cure diabetes, irritable bowel syndrome and a handful of other diseases. In addition to forfeiting to the government the nearly $12 million he made from selling the supplements in 2005 and 2006, Pham could end up in federal prison for 25 years without parole and be forced to pay another $500,000 in fines.

As part of his guilty plea, Pham admitted that he participated in a conspiracy to buy and sell unapproved new drugs and misbranded drugs over the Internet. The products involved were marketed as Diabeticine (later renamed Diamaxol, and also known as Glucolex), Digestrol (also known as Digesticine), Uricinex (also known as Uricaid), Cholestasys Rx (later renamed Cholestasys), Hyperexol and Prolipamy.

But Pham didn’t only make illegal claims. He also used stock photographs to create fraudulent customer identities to tout the effectiveness of Techmedica’s supplement products via its Websites. A fictitious doctor and nurse were also conjured up—both using the same picture on different Websites—to promote and endorse the products.

Such actions were sure to draw the attention of the U.S. Food and Drug Administration (FDA), but Techmedica attempted to prevent that from happening through the use of what is called mirror image technology. According to the Department of Justice press release, this technology assured that when each of [Techmedica’s] Websites was accessed from an FDA network computer, they displayed a “sanitized” version of the Website containing medical claims that attempted to comply with the federal Food, Drug and Cosmetic Act. However, when each of these Websites was accessed from a computer whose IP address could not be traced to the FDA, they displayed claims that the dietary supplements could cure, mitigate, treat and prevent diseases.

A sentencing hearing for Pham will be scheduled after the completion of a pre-sentence investigation by the United States Probation Office. In addition to the conspiracy, Pham pleaded guilty to one count of wire fraud related to payments in the form of a wire transfers to a bank account.

By all accounts, Pham and his company could certainly be described as one of the most rotten apples threatening to spoil the entire U.S. dietary supplement industry. Also, it looks as if this guy did just about everything necessary to ensure that the government would prosecute him for his actions. Still, his current dilemma should serve as a cautionary tale for other supplement companies that think they will never be caught by the FDA when they make illegal claims to sell their supplement products or do something else to cross the legal line. As Loren Israelsen, executive director of the United Natural Products Alliance, told Nutrition Business Journal earlier this year, the likelihood of such companies being caught is, thank goodness, rising. “Over the past 15 years, the people in our industry have been used to an eviscerated FDA that had lost funding, money, prestige and had just been gutted out. Those days are over,” Israelsen said. “This is the new FDA. They have money, manpower and mandate.”

NBJ subscribers can read more about supplement regulation in our 2009 U.S. Nutrition Industry Overview issue, which publishes this month. To order a copy of the issue, subscribe to NBJ or download a free 32-page sample issue, go to www.nutritionbusinessjournal.com.

Adverse Event Reporting a Key Issue in the Zicam Case

Jason Phillips — Tue, 23 Jun 2009 16:27:39 +0000

The long-term viability of Scottsdale-based Matrixx Initiatives could be in doubt as company officials work to mitigate consumer fears about the safety of its Zicam homeopathic cold remedies in the wake of an FDA warning letter that the company received on June 16. In the letter addressed to Acting President, CFO and COO William J. Hemelt, the FDA identified two products, Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs, as potentially harmful products that could cause the temporary or permanent loss of smell, a condition also known as anosmia. The company has voluntarily taken both products off the market based on the warning from the FDA.

The full implications of the product withdrawal are still unclear, as Matrixx scrambles to address the concerns of consumers, media, FDA and now the Securities and Exchange Commission (SEC), which has launched an informal inquiry into the product withdrawal. Company officials, while insisting that the FDA’s actions are unwarranted, have initially estimated the costs of a recall to be around $10 million, Hemelt said on a June 18 media conference call. However, those costs could rise significantly if retailers refuse to carry Matrixx Initiatives’ other products. The combined sales of the two products in question represent 40% of the company’s 2009 net sales, according to company financial releases. In addition, the FDA will require the company to file a New Drug Application (NDA) for approval on its zinc gluconicum products, which is a process that requires significant funding. The immediate costs the company faces don’t factor in potential losses due to brand damage or pending litigation, both of which could ultimately contribute to the company’s demise.

Matrixx paid $12 million in 2006 to settle 340 lawsuits brought by consumers who complained of smell problems after using Zicam products. In addition, the FDA claims that the company had knowledge of 800 additional cases of consumer adverse events that were not reported to the FDA. The company claims it did not feel the number of complaints were more than would be expected of the general population and acted on the advice of counsel in not reporting the events.

“The key issue is who knew what and when,” Loren Israelsen, executive director of the United Natural Products Alliance (UNPA), told NBJ. “What is a serious adverse event, and in this case, is the loss of smell a serious adverse event? As I read the statute, I would say it is. The intriguing question is: What did Zicam’s counsel advise them?” In a conference call with reporters on June 17, Hemelt classified the company’s product liability insurance as being “very limited.”

In addition to the up-front costs associated with a potential product recall and the down-the-road costs associated with litigation, the company’s biggest challenge will be to control the scope of the damage to the brand. “Consumers tend to assume the worst and that the rest of the product line suffers from the same consumer perceptions,” Israelsen told NBJ. The company is bracing for a downturn in sales. It had initially forecasted revenue growth of 5% for its fiscal 2010 year, but those projections have been withdrawn.

It is still too early in the case to draw any broad conclusions on how firms can work to prevent disruptions in business such as this; however, companies should be vigilant and err on the side of caution when it comes to adverse event reporting. “Companies should be investigating, getting advice and making some tough decisions as to whether they ought to act on these things,” Israelsen said.

Matrixx maintains it has done nothing wrong and will work with the FDA to reach a favorable outcome in the case. “Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its Zicam Cold Remedy intranasal gel products and anosmia,” said Hemelt in a company release. Matrixx’s price per share has fallen 73% in 7 days, with a trading price hovering slightly above $5 on June 22. U.S. consumers spent $795 million on homeopathic remedies in 2008, according to NBJ estimates.

Red Yeast Rice Research Triggers (Mostly) Positive News for Supplements

Carlotta Mast — Tue, 16 Jun 2009 17:27:46 +0000

A study published June 16 in the Annals of Internal Medicine showing the cholesterol-lowering benefits of red yeast rice triggered a cascade of news stories in the popular press—a welcome change from all of the negative headlines published over the last month about dietary supplements being unregulated, ineffective and, in some cases, dangerous.

In the study, researchers followed 62 patients who had tried taking prescription statins to lower their cholesterol but had to stop because the medications caused severe muscle pain, a common side effect of statins. All of the patients received nutrition and exercise counseling and half also received 1,800 mg of red yeast rice supplements every day. After 12 weeks, those taking the supplements saw their LDL or “bad cholesterol” drop by a significant 27%. Those who did not take the red yeast rice supplements experienced a 6% drop in LDL.

“I was pleasantly surprised with the degree of LDL lowering,” Daniel Rader, MD, a lipid specialist at the University of Pennsylvania School of Medicine and an author of the study told ABC News. “I have to confess, I did not expect this degree of LDL lowering. And there were many fewer side effects than expected.”

The news was not all positive for the supplement industry, however. In nearly every story that was published about the red yeast rice study, reporters erroneously stated that supplements are not regulated. Several stories also used the research to talk about the quality problems that have surfaced for red yeast rice and to issue warnings about supplement use. As a case in point, here’s what CNN reported:

In 2008, the supplement-industry watchdog group ConsumerLab.com analyzed 10 brands of capsules whose labels advertised 600 milligrams of red yeast rice. When the products were tested in a lab, however, they were found to contain wildly different amounts of lovastatin and other compounds. “There was a 100-fold difference from the lowest to the highest,” says ConsumerLab.com president Tod Cooperman. An unexpectedly large dose of lovastatin could cause serious side effects and could interact with other drugs.

The uncertain lovastatin content of red yeast rice products have led to a long-running dispute between the manufacturers of the pills and the federal government. A decade ago, the FDA successfully sought to regulate a red yeast rice extract known as Cholestin, claiming that the lovastatin it contained made it an unapproved statin rather than a supplement.

Any red yeast product containing more than trace amounts of lovastatin can also be regulated (and effectively banned) by the FDA, but red yeast rice products containing monacolin K have remained on the market. And though the FDA does continues to monitor the industry—in 2007, the agency warned three manufacturers that their red yeast rice products were unapproved drugs—the woolly marketplace for supplements should make consumers wary.

“I would never, under any circumstances, suggest that someone take red yeast rice,” says Dr. [Paul[ Phillips [a cardiologist who runs a clinic for statin-related muscle complications at Scripps Mercy Hospital in San Diego]. “It’s not controlled, it’s not safe, and it hasn’t been approved by the FDA in such a way that it’s formulated to be consistent.”

Such a statement is just one more reason why supplement quality and adherence to the FDA’s supplement GMPs (which go into effect for mid-size companies next week) are of the upmost importance. As Keri Marshall, medical director for Gaia Herbs, told Nutrition Business Journal recently: “GMPs will make the good companies stand out and will identify the outliers that are putting bad products on the market. They are also a great example of how the supplement industry is, in fact, regulated.”

According to NBJ research, U.S. consumer sales of red yeast rice grew 6% to $20 million in 2008. More than half of sales—$11 million—were rung up in natural & specialty retailers.

Where’s the Balance? SI Continues Attack on Supplements

Carlotta Mast — Tue, 09 Jun 2009 22:09:44 +0000

In the Letters section of its June 8 issue, Sports Illustrated ran reader responses to the May 18 supplement article, “What You don’t Know Might Kill You.” The letter Nutrition Business Journal submitted, which corrected the NBJ data that was erroneously cited in the article, was not printed—nor were any other letters supporting the industry or calling the magazine on its misleading reporting about supplements and DSHEA. (NBJ confirmed that we weren’t the only ones to respond to the Sports Illustrated article in defense of the industry and to correct misinformation published in the article). Instead, the magazine published three anti-supplement letters. Needless to say, it’s disappointing to see such blatant bias on the part of a popular mainstream publication.

For what it’s worth, following is the letter NBJ submitted to Sports Illustrated:

In a May 18 Sports Illustrated cover feature titled “What You Don’t Know Might Kill You,” David Epstein and George Dohrmann incorrectly cite Nutrition Business Journal research to create a picture of a sports supplement industry that appears much larger than it actually is. In reading the article, the average reader would come away with the idea that, according to Nutrition Business Journal, the sports supplement industry has grown to become a $20 billion business—which is simply not true. In 2007, U.S. sales of sports supplement products—the type which this Sports Illustrated article focused on—totaled $2.5 billion, while the entire U.S. sports nutrition and weight-loss market—which includes sports supplements, weight-loss pills, meal-replacement supplements, low-carb foods, nutrition bars, and sports and energy drinks—generated just under $20 billion in sales in 2007, according to Nutrition Business Journal estimates. Yes, sales of sports supplements have been growing, but they still constitute a small piece of the overall sports nutrition and weight-loss market—and this certainly was not made clear in the way Sports Illustrated cited Nutrition Business Journal’s research.

Along with getting this important fact wrong, Sports Illustrated also did its readers a disservice by publishing a story that focuses on only a small minority of products within the U.S. dietary supplement market—products that, in the words of Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), “are not representative of the mainstream companies that manufacture products that consumers choose to include in their cadre of personal healthcare options.” Furthermore, by blaming the Dietary Supplement Health and Education Act (DSHEA) for creating what Epstein and Dohrmann call a “Pandora’s Box of false claims, untested products and bogus science,” your magazine demonstrated a lack of understanding of DSHEA and the regulations it put in place for the dietary supplement industry. As Mister noted in the five-page response CRN wrote to your article, “The extreme examples the article describes appear to be a product of DSHEA, when in fact, they more likely result from FDA’s lack of enforcement of that law over the past 16 years.”

At a minimum, Sports Illustrated should run a correction regarding the Nutrition Business Journal data it incorrectly cited in its article, but also deserving is a follow-up piece that, instead of relying on sensational examples that scare readers into believing that the majority of supplements are unsafe, actually paints a true picture of dietary supplement regulation and its enforcement and maybe even helps readers understand how to identify the many safe and effective supplement products that are available to them today.

Will the Recession Really Force Kids to Eat More HoHos and Big Macs?

Carlotta Mast — Mon, 08 Jun 2009 20:59:50 +0000

The Foundation for Child Development issued a scary report last week arguing that the recession could result in children—particularly poor and very young kids—eating even more cheap, low-quality, unhealthy food than they currently do, as cash-strapped parents are forced to substitute fast food and junk food for more nutritious fare in the current economy. “There is a concern with ‘recession obesity’ apart from the general trend toward an increasing number of obese American children,” said Kenneth Land, project director of the foundation’s Youth Well-Being Index Project, which issues an annual composite assessment of how U.S. kids are faring in terms of education and health.

In issuing the report, the foundation and child advocates called for the creation of policies that help families during tough economic times and strengthen early childhood education. “We should be doing a lot more to invest in children and youth, and it’s pretty clear we’re not doing that,” Ruby Takanishi, president of the Foundation for Child Development, said June 3 during a presentation of the foundation’s report.

The idea of the recession erasing the progress that has already been made on the childhood nutrition front is pretty frightening. And, although the nation’s poorest children are likely to suffer the most nutritionally (and in many other ways) from the economic crisis, not everyone believes the economy will have parents turning toward the cheapest food possible in an effort to weather the economic storm.

In fact, some people argue that the economy is driving parents to expect more value from the products they purchase, and this could present a competitive advantage for those companies selling products that truly pack a healthy punch. “In this poor economic time, parents are a lot more conscious of how they spend their food money,” Denise Devine, president and CEO of Froose, which makes a patented children’s beverage that combines organic whole fruit and whole grains, told Nutrition Business Journal. “The value proposition is so much more important these days. Why would you pay more for a 50% watered down juice? Half the time [those products] don’t give your child any nutritional value. My product is not just a juice with isolated vitamins. It is a whole food that has all of these wonderful things, including gluten-free brown rice.”

As a mother who is more focused than ever on keeping her kids healthy by feeding them nutritious foods, I tend to agree with Devine on this one. But I also think that much more needs to be done to make healthier foods available, accessible and affordable to all children, especially in the current economic environment, and I’m hoping President Obama and U.S. Secretary of Agriculture live up to their stated promise of making improved children’s nutrition a top priority. In addition, I urge more companies to invest in helping make healthy food and nutrients available to children in need, such as Revolution Foods is doing by supporting bringing healthy school lunches to inner-city schools and Vitamin Angels is doing through its many programs here in the United States and abroad.

NBJ’s newest report—Healthy Kids’ Market Report: Breaking the Entry Barrier—was created to help companies operating in, working to move in to or simply evaluating the U.S. healthy kids’ product market better understand this market and its opportunities and challenges. Order your copy of the report via the NBJ Website.

Cognis Q1 Sales Volume Down 18% as Customers Destock Inventory

Jason Phillips — Tue, 02 Jun 2009 15:50:22 +0000

Cognis, one of the largest raw material and ingredient supply companies serving the nutrition industry, saw its sales volume decline 18% during the first quarter of 2009 compared to the same period last year, as falling consumer demand and a subsequent customer destocking effect negatively impacted company performance, Cognis reported May 27. When excluding the impact of foreign currency and company acquisitions, net sales were down 13.9% for the quarter on a year-over-year basis.

The company’s three main divisions all turned in poor results for the quarter, with the largest decline coming from the functional products division, which was down 16.9% and which services a number of industries, including the automotive, housing and engineering sectors. The company’s nutrition & health division saw its sales decrease 8.3% to 84 million euros for the quarter, as poor consumer demand contributed to weaker sales. The care chemicals division reported a sales decline of 13.8% to 370 million euros.

As rough as the first quarter was for Cognis, total sales volume for the quarter increased 5% over the fourth quarter of 2008—a period which may prove to be the trough in the consumer spending recession. The nutrition & health division was up 4% compared to Q4 of 2008. “We are starting to see a few positive signs, with the rate of volume decline slowing appreciably in March,” Cognis CEO Antonio Trius said in a prepared statement. “Our goal is to further strengthen the leading position we enjoy in growth markets driven by the wellness and sustainability trends.” Trius said Cognis remains cautiously optimistic that performance will improve in 2009. “We expect our cost-saving measures to counteract lower sales. Most of the initiatives will materialize from April onwards,” he said. “Together with our efforts on optimizing our costs, we will also stay focused on maintaining our healthy cash position.” The company also expressed hope that its strategy of investing in global wellness and sustainability trends will help the company better withstand the recession.

Cognis recorded sales of about 3 billion euros in 2008. The company is owned by private equity funds advised by Permira, GS Capital Partners and SV Life Sciences. Cognis appears to be well positioned for success within the nutrition industry as the company has made a number of strategic acquisitions in recent years, including the purchase of WILD Flavors Inc. and InterMed Discovery GmbH. However, only about 10%-15% of Cognis’s total business is devoted to the nutrition & health division, thus, the company is reliant on other sectors to improve total business performance. NBJ expects the nutrition & health division to turn in progressively more favorable results as the year progresses and the company’s cost savings measures have had a chance to take hold.

Supplement Industry Adds $61 Billion to U.S. Economy

Carlotta Mast — Thu, 28 May 2009 16:21:43 +0000

Dietary supplements are taking a beating in the mainstream press these days, but a new study funded by the Natural Products Foundation provides more positive fodder about the economic benefits provided by the supplements industry. According to the study, the dietary supplements industry contributes about $61 billion annually to the U.S. economy, supports more than 450,000 jobs and paid more than $10 billion in taxes in 2006.

“Most industry assessments primarily focus on sales, but this is really just the tip of the iceberg,” said Tracy Taylor, executive director of the Natural Products Foundation. “The labor, materials and technology necessary to move each product from a raw material to the final sale cause a whole spectrum of economic consequences.” Preliminary Nutrition Business Journal estimates peg 2008 U.S. consumer sales of dietary supplements at about $25 billion.

The Economic Impact Report, completed by Dobson | DaVanzo, a Washington D.C.-based economic research firm, is the first to quantify the dietary supplement industry’s overall financial impact on the national economy by considering such contributing factors as supply, production, research, direct employment, manufacturing, taxes, and the extended financial effects these factors produce.

NBJ’s upcoming U.S. Nutrition Industry Overview double issue, which will publish in July, will offer more details about the Natural Products Foundation’s Economic Impact Report, as well as 2008 sales and growth estimates by product segment and channel for dietary supplements and other nutrition industry product categories. To order your copy of the issue, subscribe to NBJ or download a free 32-page sample issue of the journal, go to www.nutritionbusinessjournal.com.

Sports Illustrated Slams Supplements and DSHEA

Carlotta Mast — Tue, 19 May 2009 16:36:51 +0000

In a May 18 Sports Illustrated cover feature titled “Supplements: The Dangerous Obsession with Improved Performance,” David Epstein and George Dohrmann do their best to deliver a knock-out punch to the sports supplement industry and the Dietary Supplement Health and Education Act (DSHEA), which the writers say is the basic reason the sports supplement industry has become “a Pandora’s Box of false claims, untested products and bogus science.”

The piece brings up numerous examples of professional players being punished for using supplements spiked with banned substances, delves into the recent Hydroxycut recall and rehashes the dark days of ephedra. It also features several sports supplement retailers and product developers who reap riches from selling and concocting stimulant-filled products that can be sold “with no proof of effectiveness or safety, and without approval from the FDA.” The story goes on to talk about about how GNC salespeople are paid commission by sports supplement manufacturers to push their products on “unsuspecting customers” who “are sometimes steered to a supplement that is inappropriate for their needs.” It ends with discussion of sports supplement companies manipulating the findings from clinical research or rigging the studies altogether. Taken as a whole, the articles paints a grim portrait of a rogue sports supplement industry that the writers say Nutrition Business Journal research estimates generated nearly $20 billion in U.S. sales in 2007.

The trouble is, the writers use carefully chosen examples to tell only one side of the story—and they misleadingly cite NBJ research to create a picture of an industry that appears much larger than it actually is. In 2007, U.S. sales of sports supplement products totaled $2.5 billion, while the entire U.S. sports nutrition & weight-loss (SNWL) sector—which includes sports supplements, weight-loss pills, meal-replacement supplements, low-carb foods, nutrition bars, and sports & energy drinks—generated just under $20 billion in sales in 2007. Yes, sales of sports supplements have been growing but they still constitute a relatively small piece of the overall SNWL market—and this certainly was not made clear in the way Sports Illustrated cited our research.

Exposés such as the Sports Illustrated article are, unfortunately, not new for the dietary supplement industry, and they will continue as long as there are examples of products containing banned substances, of researching being manipulated, of false or misleading claims, or of people becoming sick after using a supplement—even if these instances do not reflect the overall nature of the supplement industry at large.

The good news is that now the supplement industry has good manufacturing practices (GMPs) and the serious adverse event reporting (SAER) system to ensure supplement product quality and demonstrate the safety of dietary supplements. We also have organizations such as the Council for Responsible Nutrition, the Natural Products Association and NSF International to ably communicate the positive, responsible side of the supplement industry and help ensure the safety and quality of supplement products. But, in this day and age, the industry is likely to need more than that if it wants to protect its reputation and current regulatory structure. To weather the current media storm, all supplement companies are going to need to help defend the industry by strictly adhering to GMPs and DSHEA, by speaking out against potentially damaging products and companies, and by only doing business with those companies whose practices and ideals they support.

From ABC News to Sports Illustrated: Nutrition Industry Falls Under Fire

Carlotta Mast — Thu, 14 May 2009 17:27:38 +0000

Mainstream press coverage of the dietary supplement and healthy food and beverage markets has been anything but positive this week, and the growing barrage of negative news could be a sign of things to come for the U.S. nutrition industry—particularly if the U.S. Food and Drug Administration (FDA) continues to make headlines with what appears to be a stricter regulatory enforcement stance under the new Obama Administration.

On May 13, ABC World News with Charles Gibson included a report about FDA’s warning to General Mills regarding the cholesterol-lowering claims the company is making for its popular Cheerios cereal. This news broke the day before and triggered many print and blog stories, but I was surprised to see ABC News give it more than a minute of prime-time news coverage and include in the piece a broader message that a growing number of food manufacturers are duping Americans with the misleading health claims they put on their products.

Dietary supplements have fared no better this week. On May 12, David Epstein wrote a scathing piece on SI.com (the Sports Illustrated Website) about the adverse health events consumers reported to the FDA in 2008 about dietary supplements. The examples listed in the SI.com piece mostly discuss fringe offerings from small companies and include products with names such as Nuclear Garbage and Fireball Liquifusion. However, Epstein did address more popular, mainstream products in his piece: “Many of the reports concern extremely popular products, like Bayer’s One-A-Day Weight Smart Advanced, which lists increased heart rate—one of the common complaints—in its product information, according to the reports,” Epstein wrote. “The most popular brands and products tend to have the most reports: Herbalife, VPX, BSN, GNC, 5-Hour Energy—and there are 14 reports about Hydroxycut, which was recalled by MuscleTech earlier this month after the FDA warned consumers that it could cause liver damage and had contributed to the death of a teenager in 2007.”

By all accounts, the serious adverse event reporting (SAER) system, which went into effect in December 2007, is good for the supplement industry because it is actually helping to demonstrate the safety profile of dietary supplements. “Data shows the SAER system is functioning as a signal generator and demonstrating the safety of our class of goods,” American Herbal Products Association President Michael McGuffin told attendees of the SupplySide East Trade Show and Convention last month. “The dietary supplement industry fought hard for this good law, and AHPA is encouraged to see it working so well in its first six months.” According to AHPA, the number of supplement AERS submitted between Jan. 1, 2008 and June 30, 2008, were small compared to drug AERs—but you wouldn’t have known that from the SI.com piece.

Epstein’s story—which focuses on several products that in name alone do not appear to be helping boost the credibility of the supplements industry (Who names a supplement product Nuclear Garbage?)—did not come at a good time for the dietary supplement industry, which was already feeling the heat after Iovate Sciences’ recall of its popular Hydroxycut products earlier this month. The SI.com piece also emphasizes the damage a few allegedly bad products can inflict on the entire industry, especially in the age of the Internet.

One lesson I’m taking away from the news coverage the industry has garnered this week is that weeding out potentially dangerous products and pushing all companies to take regulatory compliance seriously are only going to grow in importance under today’s FDA, which certainly showed its muscle with the Cheerios warning. As Bruce Silverglade, legal director of the Washington-based Center for Science in the Public Interest, told Ad Age regarding the General Mills warning: “[FDA is] signaling the rest of the industry that the agency is not going to let a big market leader get away with [false or misleading claims] and won’t let anybody else get away, either.”