What a difference a year can make. Twelve months after Nutrition Business Journal reported that the weight-loss category was making strides in improving an image tarnished by the 2004 ephedra ban, Iovate Health Sciences' voluntary recall of its No. 1 selling Hydroxycut weight-loss supplement brand has cast the category under a cloud of suspicion again, hampering consumer confidence and leaving companies wondering who's next in what seems an inevitable regulatory crackdown.
Making matters worse for the weight-loss category are the lingering economic slump and the fact that many weight-loss pill-form supplements are facing double-digit dips in sales — even at a time when, according to the Centers for Disease Control, 66% of Americans are overweight and more than one-third are considered obese.
According to NBJ estimates, weight- loss pill-form supplement sales continued their downward decline in 2008, with U.S. consumer sales across all channels falling 1.1% to $1.66 billion. This represents a loss of $18 million in annual sales last year for the weight-loss supplement market. Sales in this segment are now less than they were in 2006, when annual sales reached $1.69 billion. NBJ research shows that the compound annual growth rate (CAGR) for weight-loss pill-form supplements from 1997 to 2008 was 4.2%; however, the segment's CAGR from 2003 to 2008 was -1.6%. This illustrates the rocky sales environment these products have had to navigate over the last five years. The silver lining to all of this gloom and doom, however, is the steady growth in products such as meal-replacement formulas and protein- and fiber-based weight-management offerings intended to promote fullness and accompany important lifestyle changes. In fact, the public's growing mistrust of “magic pills” touting miracle weight-loss results may be slowly leading the industry in a healthier direction toward weight-loss solutions that are backed by better science and a more inspiring safety record.
“I see a movement more toward products and ingredients that are easily understandable to the consumer and are paired with lifestyle changes, rather than magic bullet approaches that are surrounded by hype,” said Douglas Kalman, PhD, RD, director of the nutrition division of Miami Research Associates, a supplement and pharmaceutical research firm.
A Rough Few Months For Weight-Loss Supplements
Long before the Hydroxycut recall began to make headlines, the weight-loss supplement industry was clearly in trouble. Market research firm Information Resources Inc. (IRI) reports that sales of “weight control candy/tablets” — which include sales of weight-loss supplement brands such as Hydroxycut, Slimquick, Zantrex and Dexatrim as well as GlaxoSmithKline's alli over-the-counter weight-loss pill at supermarkets, drugstores and mass merchandise outlets (excluding Wal-Mart) — were down 9.5% at the end of 2008, with some products slipping by as much as 68%.
This bad sales news has been coupled with growing regulatory scrutiny of weight-loss supplements. In December 2008, the U.S. Food and Drug Administration (FDA) warned consumers not to purchase 28 different supplement products marketed for weight loss, saying they contained “undeclared, active pharmaceutical ingredients,” including anti-seizure medications, diuretics, suspected carcinogens and pharmaceuticals in dosages far exceeding FDA recommendations. The agency later boosted the list to include 72 products. One product included on the list was the StarCaps brand, which was found by the FDA to contain a potent pharmaceutical drug called bumetanide that can have serious side effects. Manufactured in Peru, StarCaps was sold at GNC, Vitamin Shoppe and other retailers and marketed through celebrity endorsements.
Then in May 2009, the FDA warned consumers to immediately stop using Hydroxycut — the nation's top-selling weight-loss supplement brand — citing 23 reports of serious health problems, ranging from jaundice and elevated liver enzymes to liver damage requiring a transplant and one death of a 19-year-old man. Ontario-based Iovate Health Sciences voluntarily recalled 14 of its products following the warning. It also swiftly reformulated a new line called Hydroxycut Advanced that was back on the shelves by summer. (Iovate declined an interview with NBJ.)
With the FDA looking into which of Hydroxycut's many commonly-used ingredients — which included garcinia cambogia, gymnema sylvestre, caffeine, green tea and ginger — might have triggered the brand's adverse event reports, the entire industry took a hit. “It's bad,” said Jordan Rubin, CEO of Garden of Life, which makes fücoTHIN, the top-selling weight-loss supplement in the natural & specialty channel. “This has cast a dark shadow over the entire industry, and no one knows which ingredient did it.” FücoTHIN contains a combination of fucoxanthin and pomegranate-seed oil and shares no common ingredients with the recalled Hydroxycut.
Loren Israelsen, executive director of the United Natural Products Alliance and a member of NBJ's editorial advisory board, said the “question of incidence of use versus incidence of injury” has also complicated the forensic analysis conducted to determine which ingredient or ingredients in Hydroxycut led to the adverse event reports (AERs) for the brand.
“There has been a lot of Hydroxycut sold over a number of years,” Israelsen said. “Why have only a few people reported injury in view of millions of units used? This is one of the challenges presented by this case.”
Iovate's new Hydroxycut Advanced product is promoted as being a thermogenic agent that boosts a person's metabolism to burn more calories and increase his or her energy. The new formula, which is also available in instant drink packets, contains a proprietary blend of vitamins C and D, goji, acerola, blueberries and other ingredients. The key thermogenic ingredient in the new formula — and the only one left over from the recalled formula — is caffeine, a stimulant commonly found in weight-loss supplements. Among the ingredients no longer listed on the Hydroxycut label include chromium, green tea root extract and garcinia cambogia, a botanical extract marketed as Super CitriMax by InterHealth Nutraceuticals.
“I don't understand how Iovate can make any claims on this new formula — there is no data of any significance on any of the ingredients in there,” said Anthony Almada, founder and chief scientific officer at IMAGINutrition and a member of NBJ's editorial advisory board. “I suspect it was designed to quickly fill the void created by the recall and help the company recoup some of the sales that it lost.”
Recall Accelerates Losses
By July 2009 — two months after the Hydroxycut recall — sales of weight-loss candy/tablets at supermarkets, drugstores and mass merchandise outlets were down 15% from July 2008, according to IRI. Ironically, Hydroxycut sales were still up 12% for the 12-month period, despite the stall in sales that occurred as the company scrambled to reformulate and get a new version of its Hydroxycut brand on the shelves.
Supplement retailer GNC — another major nutrition industry player most immediately affected by the Hydroxycut recall — saw its second quarter 2009 sales growth slow to 2.3%. GNC grew its business by 2.5%, or $21.5 million, over the first six months of 2009. That figure would have been closer to 5%, but the company reported that sales were negatively impacted in both quarters by the Hydroxycut recall.
Meanwhile, Garden of Life — which also makes a weight-loss multivitamin — saw sales of its weight-loss supplements in natural supermarkets dip 25% from June 2008 to June 2009, according to SPINS. Numerous other companies selling through the natural channel (including NOW Foods, Iron-Tek and Nature's Way) also suffered double-digit losses for the category during this 12-month period.
Take a look at figures from May 2009 (the time of the Hydroxycut recall) to July 2009, and the numbers are even bleaker, especially considering the fact that this is the time so many Americans try to quickly lose a few pounds so they can squeeze into their summer swimsuits. According to IRI, sales of weight-loss pills from May 2009 to July 2009 were down 21% from the same three-month period in 2008, with Hydroxycut sales plummeting 78%, Dexatrim sales falling 43% and Relacore sales dipping 49%. The makers of Slimquick weight control tablets (which slid into Hydroxycut's first place spot after the recall) still saw sales dip 16% from the same three-month period in 2008.
“As for sales, there is no question this has been a challenging year for our industry,” said Bob Green, president of Nutratech Inc., a raw-material supplier of the weight-loss supplement ingredient Advantra Z. But Green too sees a bright side. “Certainly, the Hydroxycut recall is an opportunity for other products to pick up market share,” he said.
Ammo Against DSHEA
Sales aside, the recent flurry of FDA activity is being viewed by many as a sign of things to come for the industry. “[The Hydroxycut recall] is a big deal for the dietary supplement industry because it will inevitably invite comparison to the ephedra AER episode, and critics of the industry will no doubt call for some review of DSHEA [the Dietary Supplement Health and Education Act] as a result,” Israelsen told NBJ in May after the recall was first announced by Iovate Health Sciences.
Following the recall, the anti-obesity group The Reality Coalition (which is funded in part by GlaxoSmithKline) called on Congress to take a new critical look at DSHEA and require weight-loss supplement companies to be held to the same scientific standards as pharmaceutical companies. The Coalition has yet to craft an actual bill or find a Congressional sponsor, but many believe that with a tough new FDA director in place and with several Congress members — including Rep. Henry Waxman, a Democrat from California and chairman of the House Committee on Energy and Commerce — expressing concerns about dietary supplement safety, the time is ripe for tighter supplement controls. “We have a new administration and a new FDA. We know who to talk to in Congress, and we are ready to act,” said Reality Coalition Co-Founder George Blackburn.
Of course, even Blackburn concedes that with a massive healthcare reform bill on the table, it could be a while before a proposed DSHEA overhaul comes to the fore on Capitol Hill. After all, more than 15 months have passed since GlaxoSmithKline asked the FDA to begin treating weight-loss claims for dietary supplements as disease claims and the agency has yet to issue a response.
Still, most agree that increased enforcement and possibly regulatory changes are in the future. Some of this will come from the FDA inspections associated with the new Good Manufacturing Practices (GMPs) that are now in place for the dietary supplement industry. According to FDA spokesperson Susan Cruzan, the FDA intends to up the frequency of inspections of manufacturing plants. Under the new industry's adverse event reporting rules, which led to the Hydroxycut recall, the agency also expects to see more adverse reporting by both manufacturers and the public, Cruzan added.
Many in the industry say they applaud the FDA's stepped-up enforcement of current supplement laws — which some hope will prevent the need for new, tougher legislation. “There are ways to improve the situation without crushing the industry, but I don't think you could go to a pharmaceutical-like model and expect the industry to survive or thrive,” said Susan Trimbo, PhD, a Florida-based consultant and former head scientist for GNC. Trimbo said she welcomes increased government enforcement and wouldn't be opposed to some regulatory changes. “There does need to be more clarity around ingredients that can be used in products, and more guidance on maximum allowable levels,” she said. “There are some ingredients out there that just shouldn't be.”
Nutratech's Green said he too is open to reasonable regulatory changes that help prevent supplement companies from making unsubstantiated or bogus claims for their weight-loss products. “Do we think weight management should be treated as a [disease] claim — as specified by the GlaxoSmithKline petition? No. But we applaud efforts to rid our industry of bloated claims,” he said.” You cannot sit on the sofa, eat potato chips, and lose weight by taking a supplement. There is no magic bullet.”
A Trend Toward Reason
Although some weight-loss supplement brands have undoubtedly lost favor with consumers in recent years, meal-replacement products, such as Abbott Nutrition's Ensure Weight Control drink, remain resilient. NBJ estimates show that sales of weight-loss meal supplements increased 5.2% to $2.3 billion in 2008, adding $112 million in new sales. This was up from the 4.2% growth the segment saw in 2007.
Meanwhile Herbalife — which generates 63% of its revenues from weight-management products — posted its fifth straight year of double-digit sales growth, with $2.4 billion in net worldwide sales in 2008. The network-marketing company's offerings include Formula 1, a soy-protein meal-replacement drink; Personalized Protein Powder, a soy and whey formula aimed at boosting satiety; and Total Control, a weight-loss supplement said to boost metabolism.
How did the Hydroxycut recall impact Herbalife? “It has had zero effect on us — a non-event from our perspective,” said Herbalife Executive Vice President Des Walsh. “Hydroxycut promised rapid weight loss with minimal effort, and that is not our message to people at all. What we want is for people to realize that weight loss without good nutrition is not beneficial to anyone.”
Kalman said he predicts a continued flood of dairy- and whey-inspired protein and fiber products aimed at, quite simply, making people get full faster. Meanwhile, he said he also sees “hyped” weight-loss supplement ingredients that have a complex mechanism of action and scarce science behind them — such as hoodia gordonii — fading in popularity. Hoodia has already taken a sharp dive in sales in recent years, according to NBJ estimates; and in 2008, Unilever dropped its plans to develop a functional drink product fortified with the weight-loss extract. “Something like fiber is more understandable to the consumer,” said Kalman. “They know it will help them feel full and that will impact their food intake. It works.”
GNC is one retailer attempting to move away from a dependence on Hydroxycut-like products. “We are working to broaden the definition of the category beyond simple thermogenic diet products to a focus on weight management programs and tools that our customers can integrate into their larger health and lifestyle plans,” Beth Kaplan, GNC's president and chief merchandising and marketing officer, told NBJ.
Does this mean consumers and manufacturers will turn away from “thermogenic agents” like caffeine, bitter orange and green tea that speed up metabolism and burn calories swiftly? Probably not. But some say a new, safer generation of thermogenic agents is emerging and that these products are able to boost metabolism without amping up the entire central nervous system.
“The industry has gotten used to this central nervous system stimulation method of creating thermogenesis,” said Greg Horn, former CEO of GNC and current president of Specialty Nutrition Group. “There are alternatives out there that don't give you the racing heart and the rest of the negative effects, but there are few that have clinical research behind them.”
Horn said one that does is fucoxanthin, which is an algae-based thermogenic antioxidant said to boost metabolism within the abdominal fat cells, rather than throughout the entire central nervous system. Fucoxanthin is the key ingredient in Garden of Life's fücoTHIN weight-loss supplement, and Horn helped bring the ingredient to market. Nutratech's Advantra Z — which is present in roughly 100 weight-loss products, including Twinlab's Ripped Fuel and CortiSlim — is also considered a non-stimulant thermogenic and has 15 clinical research studies on safety and efficacy behind it.
“If anything, this recall will have more consumers demanding weight-management supplements with tried and true thermogenic ingredients like ours, which has a wealth of research supporting its safety and efficacy,” said Green.
Moving Forward
Numerous sources for this story — including direct competitors of Hydroxycut — came to the defense of Iovate Health Sciences, pointing out that considering the millions of people who have used the product over the years, the number of adverse events was relatively small. They say the media over-hyped the Hydroxycut story. “Properly researched, regulated, prescribed and used drugs are the fourth most common cause of death, estimated at 90,000 to 160,000 per year, but are rarely reported,” Green said.
However, Almada takes a different view. “Why didn't Iovate do long-term studies to show both the efficacy and safety of the Hydroxycut brand? It would have been very easy. They certainly had the money and they pride themselves on being researched-oriented. If they did do the research, why were no studies ever published on the finished product? Perhaps the research showed the product didn't work and wasn't safe.”
In the long run, experts say the weight-loss supplement market will rebound. Human nature, after all, keeps many consumers still hoping for a quick fix to their weight-management problems. As a result, the Hydroxycut recall will have nowhere near the devastating effect the 2004 ephedra ban had on weight-loss supplement sales. “There are a lot of other products out there that could take the place of Hydroxycut,” said Vitamin Shoppe CEO Tom Tolworthy. “There was nothing that could have taken the place of ephedra.”
But there are lessons to be learned nonetheless. Lesson one: Do the research — preferably on the finished product. Lesson two: Expect to be inspected by the FDA. Lesson three: Put safety first.
“When the number one product in a category goes down it can sometimes seem like cause for celebration by competitors, but I don't think that's the case here,” said Garden of Life's Rubin. “It just means that this category is getting a lot of scrutiny right now. This could happen to anyone.”
NBJ Bottom Line
Nutrition Business Journal believes the Hydroxycut recall will ultimately be a good thing for the dietary supplement industry if it encourages weight-loss supplement manufacturers to care as much about their products' safety and efficacy as they do about expanding and protecting their bottom lines.
Given the safety scares and instances of spiked weight-loss supplements, NBJ editorial advisory board member Anthony Almada advises all consumers to call the companies they purchase dietary supplements from and ask questions: Are there independent studies conducted on humans showing the safety and efficacy of a specific finished product? Who manufactures the product, and what testing is done to ensure its safety and purity? From a consumer's perspective, this seems like good advice. However, too many supplement companies, particularly in the weight-loss category, hide behind an evasive cloak of 1-800 numbers and Websites, making it difficult for a consumer (or an industry journalist) to get through. For instance, our calls to Iovate Health Sciences' headquarters were greeted with a recorded message directing callers to a Hydroxycut Website with minimal information. A request to be connected to the administrative offices for Slimquick Laboratories for an interview was met with a polite, “We don't give that information out.” Repeated calls to CCA Industries Inc. (maker of Mega T Green Tea products) were not returned. How is this good for consumer confidence?