New Hope Network

Natural Products Expo:
East
West
New Product Launch Pad
New Hope

Insurance Coverage for CAM? Some Lawmakers Say Yes

Complementary and alternative medicine (CAM) healthcare providers are waiting to see whether federal lawmakers will pass an amendment that allows for more insurance coverage of their therapies and services. As the larger healthcare debate in Washington wages on, senators such as Tom Harkin of Iowa and Dennis Kucinich of Ohio are campaigning for licensed integrative practitioners to be included as mainstream caregivers and afforded the same insurance coverage under the new reformed healthcare system.

“It’s time to end the discrimination against alternative healthcare practices,’’ Harkin said at a congressional hearing. Advocates argue that the alternative treatments can be less expensive than conventional therapies or drugs. But critics maintain that if the alternative treatments were truly effective, they would already have been adopted by the mainstream medical community. The alternative medicine amendment, which is cosponsored by Harkin, has been adopted by a Senate committee. The committee will have control over what portions of the amendment make it into the final healthcare reform bill.

The National Center for Complementary and Alternative Medicine (NCCAM) released a report in August 2009 that concluded 38% of Americans had used some form of integrative medicine over a 12-month period in 2006 and 2007. That study also concluded that the CAM market has grown to nearly $34 billion in the U.S. Nutrition Business Journal estimates that there are more than 1.3 billion integrative medicine healthcare practitioners operating in the U.S.

NBJ offers a historical analysis of the U.S. integrative medicine market, including supplement sales, therapy revenues and a population breakdown by healthcare practitioner type in the 2009 Integrative Medicine Report.


Related Links:

CAM Insurance Coverage Is Up, But It Is Still Considered Sorely Inadequate by Many

How Much of the Growing CAM Market is Fueled by Dietary Supplement Sales?

If the Science is There, Obama Says He Will Back Complementary & Alternative Therapies

NAD Turns in SlimForce 7 to FDA, FTC for Unsubstantiated Advertising Claims

At this year’s NBJ Summit, much discussion centered on the need for industry self-policing to ferret out the bad actors—those companies making illegal product or marketing claims or selling intentionally adulterated products—so responsible companies can continue operating as is and without the need for additional government oversight. The Council for Responsible Nutrition’s (CRN) initiative with the National Advertising Division (NAD) of the Council of Better Business Bureaus to monitor and take action against unsubstantiated dietary supplement advertising is one program helping to achieve this goal.

On August 10, NAD reported that it had referred advertising for the weight-loss product SlimForce 7 to U.S. and Canadian regulatory agencies. In reviewing SlimForce 7’s advertising claims, NAD took issue with numerous statements being made for the product, including: “You can lose up to 1 pound in 8 hours,” “You just need to take 1 capsule a day at breakfast to lose as many pounds as you want,” and “You just don’t lose weight, your whole metabolism is gradually modified.”

NAD tried to contact SlimForce 7 via the 800 number and Website listed for ordering the product and sent a letter to the company’s postal address in Ontario, Canada, but never received a response. (Nutrition Business Journal had a similar experience recently when trying to contact a number of weight-loss supplement companies for our upcoming Sports Nutrition & Weight-Loss issue.)

In a press release, NAD noted that it was particularly troubled by the company’s failure to respond given that the print advertising in question appeared as a full-color, two-page spread in TV Guide and made weight-loss claims that have been found by Federal Trade Commission (FTC) to lack scientific support.

NAD said it will refer the matter to the FTC, U.S. Food and Drug Administration (FDA) and the Competition Bureau of Canada, where the SlimForce 7 company appears to be based.

NBJ’s 2009 Sports Nutrition & Weight-Loss issue, which publishes in September, will include a feature exploring the weight-loss supplement category and the potential silver lining behind the recent Hydroxycut recall. To order a copy of the issue, subscribe to NBJ or download a free 32-page sample issue, go to www.nutritionbusinessjournal.com.

Related links:

NBJ’s Sports Nutrition & Weight-Loss Report 2009

McLemore: ‘There Is No Question That a New and Improved FDA is Emerging’

Industry Making Strides in Improving Tarnished Image of Weight-Loss Supplements

How Worrisome is the Hydroxycut Recall for the Dietary Supplement Industry?

How Much of the Growing CAM Market is Fueled by Dietary Supplement Sales?

The National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services, announced the results of a 2007 survey that showed Americans spent $33.9 billion on integrative medicine, or complementary & alternative medicine (CAM) as it is commonly referred to, over the previous 12 months. That represents nearly 1.5% of total healthcare expenditures and 11.2% of total out-of-pocket healthcare expenditures in the United States. The CAM portion of the 2007 National Health Interview Survey (NHIS) was sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and concluded that approximately 38% of adults use some form of integrative medicine.

U.S. adults spent $11.9 billion on 354 million visits to practitioners. Approximately $15 billion or 44% of all integrative medicine out-of-pocket expenses were spent on non-vitamin, non-mineral, natural products such as fish oil, glucosamine and echinacea, according to NIH and NCCAM. The survey asked participants about 45 dietary supplements, including androstenedione, carnitine, creatine, DHEA, fish oils, glucosamine, lutein, lycopene, melatonin, omega fatty acids, prebiotics or probiotics and SAM-e, but not vitamins or minerals. “With so many Americans using and spending money on CAM therapies, it is extremely important to know whether the products and practices they use are safe and effective,” said Josephine Briggs, MD, director of NCCAM. “This underscores the importance of conducting rigorous research and providing evidence-based information on CAM so that health care providers and the public can make well-informed decisions.”

More than 1.3 billion integrative medicine healthcare practitioners operate in the United States, according to Nutrition Business Journal estimates. The total number of practitioners grew 3.8% in 2007, indicating a growing acceptance of alternative therapies and treatment options in the country. Medical doctors and nurses represent the largest portion of integrative medicine practitioners, with more than 700,000 now offering some form of integrative therapy or treatment, according to NBJ research. NBJ forecasts indicate that the number of U.S. integrative medicine practitioners could expand by more than 40% over the next 10 years.

NBJ offers a 10-year historical analysis of the U.S. integrative medicine market, including supplement sales and therapy revenues by healthcare practitioner type in the 2009 Integrative Medicine Report. It can be of value to health care professionals, business planners, investors, product developers, ingredient suppliers and others requiring an accurate snapshot, a reliable forecast and a comprehensive reference on the integrative medicine business.


Related Links:

If the Science is There, Obama Says He Will Back Complementary & Alternative Therapies

Briggs: Supplement Use Is Being Influenced by Science

The Inclusion of CAM in the Classroom is changing the Face of Medical Education

2009 NBJ Summit Recap: Transforming Adversity into Opportunity

The 2009 NBJ Summit is now over, and the three-day event at the St. Regis Resort in Dana Point, California proved to be an energizing and eye-opening event for many of the more than 300 executives in attendance this year. The gathering spurred some positive news about the continued resilience and vitality of the nutrition industry, particularly of dietary supplement companies, as well as some somber discussion of the regulatory and quality challenges facing the industry and what is needed moving forward to protect what could be a golden future for dietary supplements.

Below are several of the key messages that emerged from the education sessions at this year’s NBJ Summit:

• Strong supplement sales are a silver lining of the bad economy. One message delivered time and time again by NBJ Summit presenters and attendees was that dietary supplement sales are benefiting from the recession and people’s increased focus on self-care and sickness prevention. “Instead of massive obstacles, the economy is offering up a huge platter of opportunity,” Vitamin Shoppe CEO Tom Tolworthy told NBJ Summit attendees. Vitamin Shoppe, Tolworthy explained, recently experienced its 14th consecutive quarter of comp store sales growth and has seen a 20% rise in new customers. As NBJ Publisher and Editorial Director Patrick Rea noted during his state of the industry presentation, dietary supplement sales growth was stronger in 2008 than it has been since the late 1990s. NBJ expects supplement sales to continue growing in 2009 but at a slightly slower pace than in 2008.

• DSHEA is under threat. During a video address to Summit attendees, Orrin Hatch, the Republican senator from Utah who is one of the most vocal and active supporters of the Dietary Supplement Health and Education Act (DSHEA) in Congress, pulled no punches when explaining what currently faces the dietary supplement industry in Washington, D.C. “Your industry has a very difficult road ahead on Capitol Hill,” he said. “DSHEA is a war still being waged in Congress.” One change that could potentially be coming to the regulation of dietary supplements is the addition of a pre-market approval requirement for all supplement products—which, as Sen. Hatch noted, could spell the end for many responsible supplement companies.

• Industry involvement is crucial to preserving DSHEA. “Your industry must take a more active role in preventing the rollback of DSHEA,” said Sen. Hatch, who noted that he plans to continue fighting for the industry and for DSHEA. “But,” he added, “I need your unwavering support and strongly encourage your involvement in the legislative process.” He advised supplement executives to visit their congress members, educate them about the important role supplements play in health and wellness, and invite them to tour their GMP-compliant facilities to see what responsible companies are doing to safeguard product quality and safety. GNC CEO Joseph Fortunato urged companies to join and support the Coalition to Preserve DSHEA, the non-profit industry group created in 2004. “Everyone should be concerned about the sea change we are seeing in Washington,” Fortunato told NBJ Summit attendees.

• Preserving individual access to health should be industry’s message. As United Natural Products Alliance Executive Director Loren Israelsen pointed out during his dinner speech (which was aptly titled, “Industry Turbulence—Buckle Up”), at the same time DSHEA is coming “under assault,” a growing number of Americans are going bankrupt because they simply can’t pay for their healthcare expenses. People can’t afford to get sick, and this is why many are turning to dietary supplements and other less-expensive health products. So, Israelsen explained, rather than position its defense of DSHEA around the notion of “saving our vitamins,” the industry should beat the drum of preserving “the fundamental access of individuals to the kind of healthcare they want.” After all, natural self-care is not just about being able to ward off illness with a handful of supplements, it’s about “living as well as you can for as long as you can”—and this is what the industry should stand for, Israelsen said.

• How well is the supplement industry delivering on the “product promise”? This question, posed to Summit attendees by NBJ’s Rea, points to the many challenges the industry as a whole continues to face in the areas of product quality and substantiation. As Rea asked attendees, is what’s on your product label actually in the pill at the point of purchase, is it absorbed efficiently and effectively into the body, and is the product safe? If your answer is, ‘No, not always’—or even, ‘I’m not sure,’—your company has important work to do.

• Healthcare reform is coming. While it might not get done this year, healthcare reform will happen—and the dietary supplement industry must act quickly if it wants to have its voice heard and become a stakeholder in the process. The good news is that with the Obama administration and the public increasingly focused on disease prevention, the perceived importance of dietary supplements by consumers and legislators could greatly improve.

• Supplement AERs tell a positive story—one that the industry should be promoting. As Tolworthy pointed out, the supplement industry experienced 596 Serious Adverse Event Reports (SAERs) between December 2007 and October 2008—this compares to the tens of thousands of SAERs that come in annually for pharmaceutical drugs. “Our industry has a clean record on safety,” Tolworthy said. “We need to tell this story.” But as Israelsen told Summit attendees, the industry also needs to learn how to do AERS well or potentially suffer the fate of Hydroxycut and Zicam, which were both pulled off the market after AERs reporting pointed to potential safety problems.

• Retailers and consumers are hungry for product innovation. “We need a new emphasis on product innovation,” said Vitamin Shoppe’s Tolworthy, who noted that 18% of his company’s revenues are generated by the sale of new products. New products are essential to an industry that has very few big, consumer-driven brands, he added. GNC President and Chief Marketing/Merchandising Officer Beth Kaplan said product innovation is helping to fuel her company’s continued growth. “We thrive on new products,” said Kaplan, who went on to talk about some of the company’s latest GNC-branded offerings, including its new line of nitric oxide-based sports nutrition products for endurance athletes called Pro Performance AMP. “These are the kind of things that fuel growth for specialty retailers,” she added.

• Consumer education is lacking. Doug Degn, Wal-Mart’s retired executive vice president of merchandising, shared some interesting survey results with NBJ Summit attendees that highlighted the need for more consumer education about the many benefits of supplements. According to Degn, when asked why they chose not to make a supplement purchase, 40% of consumers surveyed said it was because they didn’t see a need, while 20% said they already eat a balanced diet so didn’t require supplements and 27% said it was because supplements were too expensive.

• Optimism is growing on the investment front. During his presentation on the first day of the NBJ Summit, Canaccord Adams Managing Director David Thibodeau dished out some much-needed positive market news: Investors, he said, are starting are starting to pay attention to growth markets again and valuations are slowing improving. Public markets are rebounding as well, Thibodeau explained, and many of the public companies in the nutrition industry are performing particularly well. As a case in point, Thibodeau noted that Canaccord Adams’ Healthy Living Index—which includes such companies as NBTY, Herbalife and Green Mountain Coffee—has outperformed the major indices and grown 19.1% over the last six months.

• Adversity can be transformed into opportunity. Many threats and challenges await the nutrition industry, but rather than stick its collective head in the sand the industry should approach these challenges proactively and with the collective goal of weeding out the rotten apples before they spoil the entire crop. “Rather than look at the glass as being half empty, let’s look at our opportunities to refill the glass with fresh water,” said Mark LeDoux, chairman and CEO of Natural Alternatives International Inc. and elected chairman of the Council for Responsible Nutrition

• “Excellence is not cheap.” This message from LeDoux was perhaps the most important statement uttered during the three-day NBJ Summit. As LeDoux noted, ensuring product efficacy, quality and safety requires a hefty investment in proper research, ingredient supply and testing. Product innovation and consumer education also requires substantial time and resources. Cutting corners might save money today, but it will almost certainly short change your company’s—and the industry’s—prospects tomorrow.

• The future could be bright. A key message of Metagenics Chief Scientific Officer Jeffrey Bland’s keynote presentation was one every supplement industry executive should take to heart: The dietary supplement industry is “alive and well,” Bland said, and its “golden years” are coming—provided that the goals and values of responsible, evidence-based supplement companies prevail.

Direct-Selling Supplement Marketer Vows to Stop Using Deceptive Claims and Practices

The Texas Attorney General has once again proven that it will not tolerate supplement companies preying on the sick and unsuspecting. Texas Attorney General Greg Abbott announced on July 21 that his office had reached a settlement with FXsupplements.com that will force the company to stop shipping unauthorized orders to customers, refrain from making false health claims and clearly disclose its terms of service to future purchasers. In addition, the company has agreed to provide refunds for overcharged customers.

The investigation conducted by state officials found that the company was marketing its super fruit supplement, Acai Berry Maxx, as a product that would reduce the risk of heart attack, cancer and Alzheimer’s disease. Customers who clicked on the online advertisements were instructed to pay a $5.95 shipping and handling fee for a free 15-day supply. Once the purchase was made using a credit card, customers were unknowingly entered into a negative option plan where they were automatically billed $80 for a one-month supply of the supplement if they didn’t cancel within the 14-day trial period. Under the Texas Deceptive Trade Practices Act, terms providing for ongoing contractual obligations must be disclosed clearly and conspicuously on the contract, according to the Attorney General’s press release. Investigators determined that the negative option language embedded within the company’s terms and conditions violated the state law.

Companies such as FXsupplements.com knowingly put the rest of the industry at risk with its deceptive practices. Not only was the dietary supplement company taking advantage of consumers by making claims that it could treat or mitigate diseases—which is prohibited by Food and Drug Administration (FDA) guidelines—it is also garnering widespread attention from the media for its bogus free-trial program and giving industry critics more ammunition to validate their claims that the industry is unregulated.

In an April survey conducted by NBJ asking respondents to identify challenges facing direct-to-consumer sellers in the nutrition industry, one industry executive identified this as an ongoing problem. “The growing use of online ‘free’ trial offers that aren’t free at all [represents a big challenge to business.] These scams will leave a gigantic black mark on the entire industry as the press will undoubtedly condemn all health marketers for the sins of a few,” the executive told NBJ. “This is a major issue.”

In March, the Texas Attorney General reached a $4 million settlement with the network-marketing company Mannatech for making false or misleading claims. “Texans will not tolerate illegal marketing schemes that prey upon the sick and unsuspecting,” Abbott said in a prepared statement upon the conclusion of the Mannatech settlement. Both cases should serve as fair warning to all supplement marketers that false claims and deceptive practices will no longer go unpunished. (Editor’s Note: Especially in Texas.)


Related Links:

Mannatech to Pay $6 Million Penalty for Deceptive Marketing Practices

McLemore: ‘There Is No Question That a New and Improved FDA is Emerging’

FDA Increases Enforcement Efforts, Warns Internet Marketers About Swine Flu Claims