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PLEASE NOTE: The Report will be on hiatus August 27, returning on September 3.
CRN does heavy lifting with major media in response to ‘Consumer Reports’ story During last week’s media frenzy focusing on an article from Consumer Reports on “The 12 Most Dangerous Supplements,” CRN emphasized the strong safety profile and benefits of the majority of dietary supplement products on the market that over 150 million Americans take each year to support good health. In an advisory to CRN members alerting them to the piece, CRN’s Judy Blatman reminded companies that CRN President Steve Mister was interviewed for the piece several months ago, and although he was not quoted, it was clear the publication took into account the progress the industry had made since the last time the magazine did a major story on the industry in 2004. However, that did not stop the eight-page critical assessment of the supplement industry that focused on industry regulation, through the lens of 12 mostly obscure ingredients. The story also included three pages on the pros and cons of specific multivitamin products, as well as a sidebar highlighting “Eleven supplements to consider.” Thanks to an assist from CRN member company New Hope’s Nutrition Business Journal, CRN determined that the twelve products drawing all the negative publicity accounted for less than one percent of the industry’s overall sales, and repeatedly made that point to the media. The story generated extensive news coverage, particularly among the broadcast networks. USA Today ran an editorial, with Mr. Mister penning the “Opposing View” in defense of the supplement industry. CRN’s statement appeared on the NBC Today show and was read aloud by anchor Matt Lauer. In addition, Mr. Mister also appeared on camera on ABC Nightly News. CRN’s Andrew Shao and Judy Blatman were also quoted in coverage of the story. Read more in CRN in the News. Contact Judy Blatman for more information (202-204-7680). FDA’s Sharfstein to speak at CRN conference With the adverse event reporting law and good manufacturing practices in full effect, how has the regulatory landscape changed? What can responsible industry do to help FDA in its mission to protect the public health? When can industry expect more guidance from the agency on critical issues, like new dietary ingredient notifications? Join CRN and your industry colleagues for The Conference to hear directly from Joshua Sharfstein, M.D., principal deputy commissioner at FDA—and get your questions answered. Dr. Sharfstein delivered one of the most important presentations at last year’s annual conference, and returns this year with the opening address. The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry will take place Sept. 29–Oct. 2 at the Hyatt Regency Lost Pines Resort & Spa outsideof Austin, Texas. Don't miss Dr. Sharfstein and the other top-notch speakers lined up for this year’s event. Keep an eye out for your conference brochure in the mail, encourage a colleague to come along, and register today. The CRN hotel room block closes Sept.13. RSVP for CRN’s in-person GRC meeting, September 15 CRN’s Government Relations Committee (GRC) will hold its second annual in-person meeting—on Sept.15 in Washington, D.C.—focusing on the political landscape for the 112th Congress and the legislative and political possibilities for dietary supplements on the horizon. Led by CRN’s government relations staff and outside lobbying consultants, CRN’s member company legislative experts will examine strategies to promote and protect supplement interests in the next Congress and exchange perspectives on the political landscape in a candid, open forum, assessing and developing plans for potential legislative threats. The meeting will take place Wednesday, Sept. 15 from 8:00 a.m. to 12:00 p.m. (with breakfast included) at the offices of Covington and Burling. Contact Ingrid Lebert for more information and to RSVP (202-204-7699). CRN discusses drug contamination with top FDA official CRN’s Steve Mister and Andrew Shao met with FDA’s principal deputy commissioner Joshua Sharfstein, M.D., on July 30 to discuss the problem of prescription drug contamination of products labeled as dietary supplements. FDA Chief Counsel Ralph Tyler and representatives from the agency’s Center for Food Safety and Applied Nutrition (CFSAN) and its Center for Drug Evaluation and Research (CDER) joined Dr. Sharfstein, who had indicated in his testimony before the Senate Aging Committee in May that contamination of products was his most critical concern for the supplement industry. Dr. Sharfstein noted that three categories of products (weight-loss aids, sexual enhancement products and muscle builders) are of particular concern to FDA. Representatives from other major trade associations of the supplement industry joined CRN in the meeting and all parties agreed that both FDA and industry should do more to counter this problem. CRN offered constructive suggestions for how FDA could police these products and alert industry to those known drugs and their analogues likely to be used in spiking ingredients. There was also consensus that this adulteration of products is rarely the result of accidental contamination. The parties agreed to meet again this fall to discuss specific strategies to help curb these illegal products. Contact Steve Mister for more information (202-204-7676). More enforcement, not new standards, in store for supplements, FTC says The Federal Trade Commission’s (FTC) Rich Cleland told CRN’s Steve Mister and Duffy MacKay in a meeting on July 27 that the recent consent decrees targeted at dietary supplement advertising reflect more rigorous enforcement of existing standards, not new requirements by FTC. CRN met with Mr. Cleland to discuss the recent FTC enforcement actions for supplement advertising and to highlight industry efforts to self-police retailer-initiated claims. Mr. Cleland said several areas are receiving closer attention these days, including:
Mr. Cleland insisted that these requirements for advertising are not new, but have been part of the FTC’s guidelines for supplements for some time. Read more in a confidential report for CRN Members Only. Contact Steve Mister for more information (202-204-7676). CRN presses the case for multivitamins in the Dietary Guidelines CRN’s Steve Mister, Andrew Shao and Judy Blatman met last Friday with representatives from the U.S. Department of Health & Human Services (HHS) to raise concerns about the negative, non-science-based references to multivitamins that appear in the Dietary Guidelines Advisory Committee’s draft report. CRN previously raised these issues in its written comments on the report and went the extra step to request a face-to-face meeting to discuss in person the implications for consumers of the unsubstantiated comments that multivitamins don’t offer “health benefits for healthy Americans” and may present “harmful effects.” In the meeting, CRN emphasized the importance of reaching one’s daily intake of nutrients, and identified the multivitamin as a safe way to supplement a healthy diet to assure good nutrition. In addition, CRN further expressed concern that a multivitamin with folic acid was not mentioned as an appropriate way for women of childbearing age to help prevent neural tube birth defects, a point which HHS officials acknowledged was included in the last edition of the Dietary Guidelines. CRN is optimistic following the meeting that its concerns were heard and are being considered as HHS and U.S. Department of Agriculture develop the final 2010 guidelines. Contact Steve Mister for more information (202-204-7676). CRN tips members, pre-embargo, to vitamin B study CRN alerted members pre-embargo to a study entitled “B Vitamins Do Not Prevent Vascular Events In Stroke Patients” and was prepared with a summary and comments for its companies as well as for the press. The authors of the study, which was published in The Lancet Neurology, concluded that while safe, B vitamins do not reduce vascular events in recent stroke patients and that B vitamins should not be recommended for preventing an additional stroke. CRN’s Andrew Shao, noted that, overall, the study was fairly well- designed with a well-intended hypothesis: can supplementation with low cost, safe B vitamins reduce the risk of a second cardiovascular event in patients who have already experienced one? He pointed out that the authors acknowledged that the study may have been underpowered and that incomplete adherence to the intervention and incomplete follow up also may have limited the results. Dr. Shao added, “Another important limitation is that this trial tested the hypothesis of secondary prevention, essentially treating B vitamins like drugs. The results of this study in no way address the question of whether taking B vitamins can have a beneficial effect on primary prevention. Data from observational studies consistently demonstrate a primary preventive effect of lower homocysteine on cardiovascular outcomes. This study does not refute those findings.” Read more in CRN in the News. CRN/Virgo webinar examines liability for retailer-initiated claims Retailers are not only subject to liability for false and deceptive advertising of store brands, but for all products sold in their stores—the fact that a manufacturer created the claims and just put the retailer’s name on the package does not absolve the retailer of liability. So said Federal Trade Commission (FTC) attorney Gregory W. Fortsch during last week’s webinar on “Dietary Supplement Claims in the Retail Environment: Roles and Responsibilities of Manufacturers and Retailers,” now available on demand via the Natural Products Insider website. The event was co-sponsored by CRN and Virgo Publishing. Panelists remarked that responsible dietary supplement manufacturers dedicate significant resources to comply with federal regulatory guidelines for advertising and labeling. Creating marketing material requires a qualified team that includes scientific expertise to perform studies or evaluate existing scientific literature, marketing talent that can translate the available science into terms that consumers understand, and legal and regulatory review to ensure that claims being made are in compliance with FDA and FTC requirements and guidelines. The webinar provided advice for manufacturers, retailers and direct sellers. Experts discussed legal requirements regarding claims made by retail sellers at the point of sale and explored manufacturer responsibility for compliance with both state and federal advertising guidelines in the retail setting, providing examples of industry best practices. Companies who missed the live event can still log on to the webinar and hear Anne Maher, Partner, Kleinfeld Kaplan & Becker, LLP, Donna DiDomenico, Director of Training & Development, The Vitamin Shoppe, Dick Laurin, Senior Corporate Counsel, Compliance, Mannatech Incorporated and Mr. Fortsch share their expertise. CRN members can access the webinar on demand for $149. In addition, CRN and Virgo Publishing are developing a special promotion that will enable manufacturers to share the lessons learned with their retailer partners by purchasing a package of webinar passes they can distribute among their key retail accounts.CRN discusses supplement regulation and naturopathy CRN’s Duffy MacKay, himself a licensed naturopathic doctor (N.D.), addressed an audience of hundreds of fellow naturopaths and other healthcare professionals at the 25th anniversary meeting of the American Association of Naturopathic Physicians this week in Portland, Ore. His presentation, “Dietary Supplement Regulations: Implications for the Practicing Naturopathic Physician,” outlined the current regulatory framework for the supplement industry and provided specific examples of how some of the more recent regulatory developments have shaped the marketplace. Dr. MacKay discussed adverse event reporting, good manufacturing practices, claims, industry self-regulation and the legal responsibilities of N.D.s selling supplements to the public. “It’s a critical topic for N.D.s because we’re talking about the quality and safety of a primary care modality—supplements. Furthermore, our stakeholders’ perception of supplements is related to their perception of naturopathic care—naturopathy, complementary and alternative medicine (CAM), and supplements are all lumped into one bucket,” Dr. MacKay observed. CRN reaches out to practitioners at Retail Clinician Congress CRN’s Duffy MacKay and representatives from CRN member companies Bayer Healthcare, Embria Health Sciences, Nutramax Laboratories, Pharmavite and Schiff Nutrition were on-site at the Retail Clinician Education Congress (RCEC) last week in Orlando, Fla. Hosting approximately 500 nurse practitioners from retail clinics across the U.S., the meeting featured an exhibit area in which CRN and its members hosted an informational pavilion, as well as expert presentations. Speakers on supplements included Tieraona Low Dog, M.D., who discussed “Integrating Supplement Usage in Women’s Health Issues.” She covered mainstream products such as calcium, vitamin D, cranberry, vitamin B12, pre-natal multivitamins with iodine and folic acid and probiotics. Dr. MacKay and CRN member representatives from Bayer HealthCare, Embria, Nutramax Laboratories, Pharmavite and Schiff Nutrition met with the medical director of Minute Clinics, Andrew Sussman, M.D. While Dr. Sussman indicated their model does not include primary care or nutrition advice, he said things might be different in the future. Dr. MacKay encouraged him to consider CRN as a resource for science-based information on dietary supplements and highlighted the association’s responsible member base of companies who adhere to a voluntary code of ethics and self-regulatory programs in addition to the mandatory good manufacturing practices required by law. SupplySide West discounts available to CRN members SupplySide West, taking place Oct. 19–23 at The Venetian & The Sands Expo in Las Vegas, Nevada, features a booth exhibit hall of more than 1,200 global ingredient suppliers and manufacturing service providers, as well as daily networking events, and more than 100 hours of educational opportunities—including the three-day education program, four workshops, more than 40 VendorWorks Presentations and good manufacturing practices (GMP) training. Once again, thanks to a special partnership between CRN and Virgo Publishing, CRN members can get a $50 discount off registration. Visit www.supplysideshow.com or call (800) 454-5760 and mention promo code “CRNvip” to receive the discount. The discount is valid through Oct. 15, does not apply to a previously paid registration, and is available to consumer packaged goods/finished product manufacturers.CRN promotes science staffer Haiuyen Nguyen has been promoted to the position of research manager at CRN. Working with Drs. Shao, Hathcock, and MacKay, Ms. Nguyen provides research assistance and support to CRN’s science department. She is responsible for CRN’s Research Watch, a service for the association’s members, and is involved in other initiatives of the CRN Regulatory Affairs Committee and Senior Scientific Advisory Council.
Senate food safety bill could move when Congress returns in September The Senate Health, Education, Labor and Pension (HELP) Committee held a late afternoon meeting Aug. 12 to review the updated version of S 510—the FDA Food Safety Modernization Act (FDAFSMA). Chairman Tom Harkin (D-IA), Ranking Member Mike Enzi (R-WY), and other senators representing the bipartisan co-sponsors reviewed highlights from the managers’ package as well as the Congressional Budget Office score of the final legislation. While nothing has been scheduled yet, it is expected that the bill could be heard on the Senate floor in early September. CRN’s Mike Greene attended and reports there is a new section (Sec. 113) in the legislation that would require FDA and the Drug Enforcement Agency to share information when a new dietary ingredient notification (NDIN) includes an anabolic steroid, and would also require FDA to issue its (NDIN) guidance no later than 180 days following enactment of FDAFSMA. “The language is virtually identical to language in Senator Harkin and Hatch’s Dietary Supplement Full Implementation and Enforcement Act (DSFIEA—S 3414), and reflects an earlier agreement between Senators McCain, Dorgan, Hatch, Harkin and Enzi when McCain withdrew support for the Dietary Supplement Safety Act of 2010 (S 3002) earlier this year,” Mr. Greene explained. CRN previously announced its support of the bill, with CRN’s Steve Mister saying in a statement, “While no single bill can fully address the breadth of food protection challenges, FDAFSMA is a large step forward in making sure that Americans are adequately protected.” If the Senate passes its food safety legislation next month, it will go to conference with the House of Representatives’ version of food safety, HR 2749, passed in July of 2009. Read more in CRN in the News. Contact Ingrid Lebert for more information (202-204-7699).Legislators urge HHS to demand resources for FDA “We have seen in recent months how regulatory failures can be catastrophic, both in the impacts on our citizens and economic costs to our nation…We also are concerned that these problems could cause the public to view FDA as a failed agency—not because the agency isn’t doing its best, but because FDA simply doesn’t have the resources to be fully effective,” Representatives Henry Waxman (D-CA), John Dingell (D-MI), Bart Stupak (D-MI) and Frank Pallone (D-NJ), along with Senator Tom Harkin (D-IA), wrote to Health and Human Services Secretary Kathleen Sebelius in an Aug. 4 letter. “…We urge you to ensure that your FY 2012 budget request will reflect the urgency of the findings of our Nation’s experts by setting forth a funding level that will allow the Agency to fulfill its vitally important public health mission…” they added. “We recognize there is little you, as Secretary, can do to stem the influx of demands placed on the Agency,” they acknowledged. “There is, however, much you can do to strengthen the Agency so that it is prepared to meet these challenges: it is incumbent on you to request—and to demand—that FDA receives the resources it needs to do its job and do it well.” Contact Ingrid Lebert for more information (202-204-7699).
NCCAM director says consumers must be informed, do their homework “…[C]aveat emptor (let the buyer beware)—I urge you to be a wise consumer and get the facts before you use any dietary supplement or CAM product or practice,” Josephine Briggs, M.D., director of the National Center for Complementary and Alternative Medicine (NCCAM), wrote in her August “Directors Page” letter to consumers. “In particular, remember that ‘natural’ does not necessarily mean safe, and that some herbal supplements can interact in harmful ways with other drugs, medications, or dietary supplements you may be taking.” Dr. Briggs also advised that consumers always discuss with their healthcare provider any CAM therapies they may be using or considering using in order to ensure safe and coordinated care. “Through our research, we are building the evidence base on CAM, but we don't have enough information to proclaim cures and to always ensure safety. Headlines sell, but science must be the bedrock. Consumers need to look beyond the hype and get the facts,” Dr. Briggs said.
CRN view on supplement safety runs as ‘USA Today’ guest editorial “The media circus surrounding the latest issue of Consumer Reports implicates the entire aisle of mainstream dietary supplements based on 12 ingredients that combined make up less than 1 percent of the marketplace. Yet given the attention, one would think these 12 herbs represent the mainstream dietary supplement aisle at your neighborhood pharmacy. They do not,” CRN’s Steve Mister wrote in a bylined guest editorial that ran last week in USA Today opposite the publication’s own editorial claiming the supplement category is unsafe. The editorial was prompted by the Consumer Reports article on dietary supplements. In his piece, Mr. Mister also focused on the positive portion of the Consumer Reports story, stating “Consumer Reports even identifies 11 products consumers should consider, including vitamin D, fish oil, cranberry and calcium. More than 65 percent of American adults take dietary supplements—from multivitamins to fiber to glucosamine—because strong science demonstrates their healthful effects,” he added. “Calls for pre-market approval show a disregard for consumers who want access to a wide variety of supplement products. What FDA needs from Congress is more funding, not new laws. Meanwhile, consumers should talk to their doctors or other health care professionals about any of the supplements they use to maintain a healthy lifestyle. That's good advice regardless of the law,” Mr. Mister observed. ‘Today’ show includes CRN response to ‘Consumer Reports’ article Among the many follow-up stories on the Consumer Reports article taking a critical look at 12 rather obscure supplements, was a segment on NBC’s Today show. “The dietary supplement industry has fought for stronger enforcement of regulations to further ensure consumer safety. More than 150 Million Americans take vitamins and other supplements each year for the health benefits they provide, and overall the supplement category has a very strong safety profile,” CRN said in a statement that appeared on screen and was read aloud by Today show anchor Matt Lauer. CRN also recommended that consumers follow label directions, buy from reputable companies and talk to their doctor or healthcare professional about the supplements they take. CRN provides counterpoints to ‘Consumer Reports’ attack on supplement regulation “…[T]hey are an insubstantial amount of the dietary supplement marketplace,” CRN’s Steve Mister said on the air on ABC Nightly News’ coverage of the dozen ingredients cited for supposed safety issues in a recent Consumer Reports article.
CRN’s Andrew Shao is quoted in WebMD’s coverage saying the report is “a little bit sensationalized...Any time you pick adverse experiences from a handful of individuals, you know it is being sensationalized. It doesn't represent the totality of the evidence." He pointed out that, "Some of these ingredients [in the report] have been flagged by the FDA years ago," but acknowledged their availability, adding that the agency needs more resources for enforcement. In addition, CRN’s Judy Blatman spoke to NutraIngredients.com about the article, defending the way the supplement industry is regulated. “If FDA believes these [12] products truly represent a health hazard, it has the ability under DSHEA to remove them from the market.” CRN’s views also appeared throughout trade press coverage of the article, including Nutraceuticals World.
Treatment trial does not discount potential prevention benefits for vitamin B, CRN reiterates “The trial tested the hypothesis of secondary prevention, essentially treating B vitamins like drugs. The results of this study in no way address the question of whether taking B vitamins can have a beneficial effect on primary prevention,” CRN’s Andrew Shao said in a NutraIngredients.com article discussing results of a study on vitamin B and cardiovascular events. “The author highlights the need for continued research in this area, something we would agree with, and also reiterates that subtle benefits can have strong impacts on a population basis, and specifically notes his conclusions are in reference to secondary (not primary) prevention,” Dr. Shao added. “It’s important for researchers to include these kinds of qualifiers, and we appreciate that the author has done so.”CRN speculates on future of food safety legislation Food safety enforcement legislation looks likely to be passed by the Senate after Congress returns from its August recess, according to industry trade reports. “The discussions and negotiations have been going on in the House and Senate for the last four years, even five,” CRN’s Mike Greene said in a Tan Sheet article discussing the Aug. 12 Senate Health, Education, Labor and Pensions Committee briefing for food industry stakeholders about the FDA Food Safety Modernization Act, S 510. While a similar bill has already received approval from the House of Representatives, the Senate bill has not progressed since it passed the committee in November 2009. “…[T]o some degree we're hitting a point where I think most folks will be able to carve out some agreement that everyone can live with,” Mr. Greene added. However, as The Tan Sheet noted, enacting a law requiring new federal regulations may not appear to be an effective campaign tool for members who face highly contested elections this year. “A lot of people aren't going to want to support legislation that could make one party look better than the other,” Mr. Greene observed. “Stalling could be an equally efficient tactic.” CRN defends value of calcium supplementation despite meta-analysis results “Adequate calcium intake is vital to building and maintaining healthy bones, and to preventing osteoporosis—which is caused by a failure to build adequate bone mass or by bone loss that occurs as we age. Most people do not get enough calcium from diet alone, and this is where a calcium supplement can be important to consumers of all ages,” CRN’s Andrew Shao is quoted from a statement throughout various press outlets in response to results of a meta-analysis of the effects of calcium supplements on the risk of cardiovascular events. NutraIngredients.com, HealthJockey.com, and News-Fire.com were among the web-based publications citing Dr. Shao. “The results from this meta-analysis do not undermine the value calcium supplements offer to those concerned with maintaining or increasing bone density, as years of research shows these products do,” he added. Dr. Shao explained, “The authors characterize these findings as though all of the selected studies suggest increased risk. In fact, the opposite is true: most of the studies do not suggest increased risk. Bone health is one of the most common reasons why healthcare professionals recommend calcium supplements; there are other health benefits that may be associated with calcium supplementation, such as reduction of colon cancer risk. This is not even considered by the authors. It’s unfortunate that these investigators are making sweeping judgments about the value of calcium supplements by only assessing a handful of handpicked studies.”
Study shows capsinoids may help weight-loss efforts Capsinoids show promise as a weight loss-aid, according to a small study published online in the journal Nutrition & Metabolism. These compounds are derived from sweet peppers, and unlike their cousin, capsaicin—also studied for its health effects—capsinoids are non-pungent. Through mechanisms still unclear to researchers, capsinoids increased resting energy expenditure and fat metabolism in study subjects—twelve young, healthy and fit males. Subjects were randomly assigned to 10 mg purified capsinoids or placebo one half hour prior to 90 minutes of moderate exercise. During the 30-minute resting period and during exercise, measurements of energy expenditure and lipid utilization were taken. When subjects took capsinoids, oxygen uptake and plasma norepinephrine increased during the resting period, while levels of free fatty acids, plasma glycerol and respiratory exchange ratio decreased. These changes indicated that subjects expended more energy (burned more calories), and used fat as an energy source, as opposed to other sources, such as sugar, while at rest following capsinoid ingestion. There were no significant differences observed during exercise between capsinoids and placebo conditions, however. Elevating ones resting metabolic rate can be a challenge when losing weight, so capsinoids may assist with weight reduction, in combination with diet and exercise, researchers suggest. See the Research Watch section of CRN's Members Only website for more information on this and other studies.
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