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Top regulators to kick off CRN annual conference sessions With a new administration in Washington, D.C., there’s also a new FDA and Federal Trade Commission (FTC) overseeing the supplement industry—and CRN is bringing in the new to its annual conference in October. Two of the nation’s top government regulators will headline The Conference—Joshua Sharfstein, M.D., FDA’s principal deputy commissioner, and David Vladeck, FTC’s director, Bureau of Consumer Protection. The Conference takes place October 21-24, immediately following The Workshop, at the brand new Terranea Resort in Rancho Palos Verdes, Calif. Registration is now open and several options are available for attendance at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry, The Workshop: CRN’s Day of Science or both. See CRN’s events website for details: www.crnusa.org/2009events. CRN calls for supplier qualification guidelines to combat EMA Ingredient supplier qualification is critical in combating economically motivated adulteration (EMA), CRN observed in its comments to FDA, submitted today. “For dietary supplements, high standards for manufacturing practices combined with routine and thorough facility inspections by FDA (and other) officials are key components in the battle against EMA…However, [good manufacturing practices], even when thoroughly implemented are not themselves adequate to defend against EMA,” CRN’s Andrew Shao wrote in comments submitted on behalf of the association.
“These all point to a need for the dietary supplement industry to develop ingredient supplier qualification guidelines.” CRN’s comments pointed to the Standardized Information on Dietary Ingredients (SIDI) protocol developed by the supplement industry as a key tool to assist with qualification of ingredient suppliers and the association urged FDA to work collaboratively with industry in developing guidelines. In addition, CRN recognized the need for and importance of informing FDA about known or suspected instances of EMA related to dietary supplements or dietary supplement ingredients. Contact Andrew Shao for more information (202-204-7660). |
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Award-winning ‘Life...supplemented’ program recognized for communications excellence
The CRN-managed consumer wellness program, “Life...supplemented,” took “honorable mention” in the issue-specific website category of the 2009 Gold Circle Awards. The award-winning website—www.lifesupplemented.org—encourages visitors to assess their level of wellness through its free interactive tool, My Wellness Scorecard, which focuses on the three pillars of wellness—healthy diet, dietary supplements and exercise—along with other smart healthy lifestyle choices. The Gold Circle Awards, the American Society of Association Executives’ (ASAE) annual awards competition, recognizes associations and nonprofit organizations that have demonstrated excellence in communication within a number of categories, including annual reports, magazines, newsletters, blogs, podcasts, innovative communications and others. The competition received more than 300 entries this year, and "Life…supplemented" took second place in its category.Join the growing group of companies funding ‘Life…supplemented’
As the “Life…supplemented” program moves into its third year, CRN’s CEO urged member companies to pledge their financial support. CRN is asking every member company to play a role in ensuring a third successful year for this proactive consumer wellness program that urges responsible use of dietary supplements in combination with other healthy habits.
The list of companies stepping up to fund the campaign is growing—Douglas Laboratories, GNC, Natural Alternatives International, Natural Factors Nutritional Products, New Hope, Shaklee Corporation, Sierra Mountain Minerals, and Wyeth are the latest companies to show their commitment to a program that has generated over 900 million media impressions in two short years.
These companies join Kyowa Hakko, Nutramax Laboratories, Perrigo Company, Schiff Nutrition, and The Vitamin Shoppe as Year Three funders of the program—and Steering Committee members BASF, Bayer, DSM, NBTY and Pharmavite—as Year Three funders.
The campaign has resulted in more than 2,300 positive stories to date. In addition, data from the “Life…supplemented” survey of dietary supplement use by healthcare professionals has just been published in an online peer-reviewed journal, which adds further credibility to the campaign’s relevance. Results of the successful campaign can be viewed on the “Life…supplemented” website. Contact Judy Blatman for more information about funding (202-204-7680).
CRN Chair LeDoux keynotes NBJ Summit opener with industry call to action
Companies that don’t get politically active will “become legislative road kill,” CRN Board Chairman Mark LeDoux warned the audience at last week’s NBJ Summit in Dana Point, Calif. He urged the dietary supplement industry to get out of its “cocoon” and get to know their members of Congress, invite them on facilities tours, and educate them on the economic importance of these facilities for their congressional districts.
Mr. LeDoux told attendees that they must be sure their companies are complying with the new dietary supplement good manufacturing practices and strictly adhering to requirements for their advertising. “These times call for a sensible approach to food safety,” said Mr. LeDoux, emphasizing the need for industry to get its house in order. “All companies need to act like industry leaders by assuring their consumers that their products are well-made and live up to their claims. Excellence is not cheap,” he said, but observed that the market demands no less.
Mr. LeDoux then called on companies to police each other with self-regulatory efforts, such as the CRN-funded advertising review initiative with the National Advertising Division (NAD) of the Council for Better Business Bureaus (CBBB). “And if someone sends you adulterated ingredients, contact FDA, don’t just destroy the shipment,” he added.CRN, Virgo Publishing team up for fall webinars
CRN and member company Virgo Publishing are partnering for the third consecutive year on educational webinars for the dietary supplement industry, with two webinars to be held in fall 2009.
On Sept. 30, a webinar moderated by CRN’s Andrew Shao, entitled Emerging international markets for dietary supplements: opportunities and challenges will provide practical information for dietary supplement ingredient suppliers and manufacturers doing business, or looking to do business, in Latin America and Southeast Asia, focusing on the associated regulatory and policy challenges, including potential trade barriers.
On Nov. 3, CRN’s Duffy MacKay moderates a webinar entitled, Avoiding Red Flags and Monetary Penalties—What Every Company Needs to Know About Dietary Supplement Advertising. This session will examine some of the lesser-understood requirements for dietary supplement advertising and offer guidelines to help companies interpret and stay within the regulatory framework.
On-line registration will be available beginning in mid-August through Virgo Publications. Both webinars are open to CRN members and non-members. For more information contact Judy Blatman (202-204-7680).
CRN discusses self-regulation at FTC request
CRN’s self-regulatory initiative with the National Advertising Division (NAD) Council of Better Business Bureaus (CBBB) has increased attention to untruthful and misleading advertising of dietary supplement products since its launch in 2007 and has been getting noticed by regulators, legislators and other industry stakeholders. (See a related story in Hill Happenings.) In fact, FTC requested that CRN discuss the program with delegates from the Egyptian Consumer Protection Agency visiting this week. CRN’s Duffy MacKay gave a presentation to the group, providing an overview of U.S. government regulations for supplements and the CRN/NAD initiative, the latter focusing on the importance of industry self-regulation.
Dr. MacKay underscored the importance of protecting consumers’ trust, observing, “All dietary supplements are affected when any one of them fails to live up to its advertising claims…Responsible industry prefers a level playing field for marketing its products.”CRN reports from ODS soy workshop
The biggest dilemma in soy research lies in translating epidemiology and preclinical data to human clinical trials, experts said at a scientific workshop held this week by the National Institutes of Health’s (NIH) Office of Dietary Supplements (ODS), attended by CRN’s Duffy MacKay. ODS held the workshop in collaboration with other NIH bodies including the Division of Nutrition Research Coordination, the National Cancer Institute, the National Center for Complementary and Alternative Medicine and others, to provide guidance for the next generation of soy protein/soy isoflavone human research.
Speakers at the workshop noted concerns about interpreting research because of the variability in the chemical composition of what is called “soy.” They called for careful characterization of materials used in studies and for details on materials and methods used to be reported in all clinical studies. In addition, they emphasized that guidelines should be established to standardize reporting information about dietary proteins/isoflavones that are used in human clinical trials.
Researchers noted that the current published literature is difficult to analyze because the poor characterization of materials used and provided suggestions on how this might be improved. They pointed to the validated and official analytical methods for accurate identification and quantification of soy isoflavones published by AOAC as a valuable resource. The upcoming National Institute of Standards Technology (NIST) Standardized Reference Material (SRMs) for isoflavones, and several natural matrix soy materials, is expected within a year. ODS will publish a white paper on soy protein and isoflavone research soon (no timeframe was indicated). Contact Duffy MacKay for more information (202-204-7664)
Coalition to Preserve DSHEA gets new interim leadership from CRN member company
The Coalition to Preserve DSHEA has elected General Nutrition Center (GNC) General Counsel Jerry Stubenhofer as the interim executive director replacing current Coalition Executive Director David Seckman who is stepping down from that position when he resigns as executive director/CEO of the Natural Products Association on July 31. CRN serves on the Coalition Board as a non-voting member and participates in its Congressional lobbying efforts. The Coalition also announced plans for a new lobbying campaign that will include attracting new Congressional allies for the industry and strengthening its grassroots support among consumers. The first step is to raise funds to finance this effort and GNC has already demonstrated leadership in this area. GNC CEO Joe Fortunato spoke at last week’s NBJ Summit, urging companies to help fund this effort in the face of new threats to the Dietary Supplement Health and Education Act (DSHEA) from Congress and FDA. A video message from Sen. Orrin Hatch (R-UT) called on industry members to be vigilant and prepare for legislation by critics of dietary supplements that would threaten the principles of DSHEA.Hill Happenings |
CRN’s efforts at self-regulation highlighted at Hill hearing
At a recent Senate hearing on advertising issues, David Vladeck, director of the Bureau of Consumer Protection at the Federal Trade Commission, gave testimony that was critical of deceptive advertising practices, using as examples specific dietary supplement advertisements.
On a more positive note, in his testimony at the same hearing, Lee Peeler, president of the National Advertising Review Council (NARC), and former Deputy Director of the FTC’s Bureau of Consumer Protection, chose to spotlight the value of CRN’s self-regulatory efforts on behalf of the dietary supplement industry. Referencing the CRN/National Advertising Division (NAD) self-regulatory initiative, Mr. Peeler used this effort as an example of what responsible industry can do to protect both consumers and business.
“In the past two years, NAD has reviewed advertising for and issued decisions regarding more than 50 separate dietary supplement products, including resveratrol, omega-3 oil, green tea extract and glucosamine, substantially increasing NAD oversight in this important area,” testified Mr. Peeler, whose Council sets the policies for NAD.
The hearing was convened by Senate Consumer Protection, Product Safety and Insurance Subcommittee Chair Mark Pryor (D-AR) to address deceptive advertising practices and ascertain whether FTC has the resources and enforcement authority to act against misleading advertising. CRN attended the hearing, providing on-line, real-time updates to its member companies through Twitter. More information, testimony and a webcast of the hearing can be found on the U.S. Committee for Commerce, Science and Transportation’s website. Contact Ingrid Lebert (202-204-7699).
FSEA passes House; to date, no action on Senate version
The Food Safety Enhancement Act of 2009 (FSEA/HR 2749) passed a House vote this week after some word wrangling among members of Congress. There were no changes to the bill on the House floor affecting issues of concern to CRN, such as redundancy with existing good manufacturing practice requirements for dietary supplements, the feasibility of accelerated FDA inspection timelines in the face of resource shortages and other matters. While still in committee, the annual registration fees were cut from $1,000 to $500 and a country-of-origin labeling (COOL) requirement for all ingredients was replaced with country-of-last-processing labeling requirement for the final product.
The Senate version is less troublesome, says CRN’s Mike Greene, explaining that Sen. Richard Durbin’s (D-IL) bill doesn’t have registration user fees or COOL requirements. He noted that while a bipartisan bill is expected to move through the Senate, neither Sen. Hatch (R-UT) nor Sen. Harkin (D-IA) have co-sponsored. “We could see Senate action in the fall if healthcare debate stalls or in ‘vacuum of health debate if they can’t accomplish it’. Senators will be looking for things to accomplish while healthcare reform interests negotiate,” Mr. Greene said. Contact Mike Greene for more information (202-204-7690).New bill would include supplements in FSA deductions
Rep. Earl Blumenauer (D-OR) and Rep. Ginny Brown-Waite (R-FL) this week introduced—the “Tax Equity for Meal Replacements and [Dietary] Supplements Act of 2009.” This bipartisan legislation has evolved from the health savings account (HSA)/ flex spending account (FSA) legislation of prior Congresses, introduced in the past by former Rep. Chris Cannon (R-UT) and now Chairman Ed Towns (D-NY) of the Oversight and Government Reform Committee.
The new bill would amend the Internal Revenue Code to exclude from gross income those amounts reimbursed by an individual’s employer for certain dietary supplements and meal replacement products.” It would allow consumers to deduct dietary supplements and meal replacements with health claims from their FSAs. Rep. Blumenauer and Rep. Brown-Waite sit on the House Ways and Means Committee, which has jurisdiction over flexible savings accounts. Contact Mike Greene for more information. (202-204-7690).FDA head discusses current challenges in alliance address
The way food and ingredients are inspected has drastically changed in recent years, as ever-evolving technology and a growing global marketplace make for a more complex world, FDA Commissioner Margaret Hamburg, M.D., observed during a talk she gave to members of the Alliance for a Stronger FDA last week. She emphasized her agency’s commitment to adapting to meet these challenges noting that FDA is rethinking its inspection activities, especially with regard to aspects of specialization and interchangeability. She stated that FDA would engage in partnerships with states and other federal agencies to bolster inspection capabilities, and that the agency plans to partner with Europe and Japan to help with inspections.
Dr. Hamburg also generally discussed the agency’s role in protecting public health, identifying four key priorities: food and import safety; strengthening the regulatory science-base with increased understanding of when and how a product is considered safe and effective; tobacco regulation; and H1N1 virus (swine flu) preparedness.
She commended the Alliance, of which CRN is a member, for their efforts toward increasing funds for FDA, but acknowledged that the agency remains in need of additional resources in order to operate most effectively. FDA will receive a total of $1 billion in new money to hire new staff, build technology and infrastructure and other activities, however, the agency’s breadth of regulatory responsibility is far-reaching and it faces many challenges.
Federal Watch |
FDA warns consumers about steroid-containing bodybuilding products illegally marketed as supplements
FDA this week held an audio press conference (which CRN attended) and issued a Public Health Advisory (PHA) warning consumers to stop using bodybuilding products that are represented as containing steroids or steroid-like substances. “Many of these products are marketed as dietary supplements,” the agency said. The PHA notifies consumers and health care professionals that FDA has received reports of serious adverse events associated with the use of bodybuilding products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung).
As part of the PHA and press conference, FDA also noted its recent actions against American Cellular Laboratories Inc. for marketing and distributing bodybuilding products containing synthetic steroid substances.
The agency noted that although these products containing steroids may be marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.
NCCAM data shows strong consumer use of CAM therapies, including supplements
“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 P. Briggs, M.D., director of the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH). Highlighting data from recent government surveys, Dr. Briggs added, “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.”
NCCAM cited data from a 2007 government survey showing Americans spent $33.9 billion out-of-pocket during the previous 12 months on CAM therapies including medical and health care systems, practices, and products such as herbal supplements, meditation, chiropractic, and acupuncture that are not generally considered to be part of conventional medicine. CAM accounts for approximately 1.5 percent of total health care expenditures ($2.2 trillion) and 11.2 percent of total out-of-pocket expenditures (conventional out-of-pocket: $286.6 billion and CAM out-of-pocket: $33.9 billion) on health care in the U.S. More information, including the full report, is available on the NCCAM website.
ODS provides web resource on analytical methods program
The National Institutes of Health (NIH) Office of Dietary Supplements (ODS) this week made available on its website information about its Dietary Supplements Analytical Methods and Reference Materials (AMRM) Program. The program, launched in 2002, encourages the development of validated analytical methods and reference materials to meet the needs of manufacturers, regulators, contract laboratories, academicians, and researchers.
The newly posted web resource includes links to reference materials for dietary supplement analysis, focusing on the ODS collaboration with the National Institute of Standards and Technology (NIST) to develop reference materials and calibration standards relevant to dietary supplements. On the website, users will find information on these materials’ stage of development, public availability, and resulting publications. Information on the ODS-supported laboratory quality assurance program established by the NIST and information on how to participate in upcoming exercises is also available, along with listings of analytical methods by stages of development and supporting articles in the Journal of AOAC International.
CRN in the News |
CRN reacts to FDA enforcement against certain bodybuilding products
"This isn't an issue of supplements, it's an issue of criminals and criminal activity," CRN’s Andrew Shao said in an Associated Press article on FDA’s recent warnings about misbranded, adulterated products being marketed and distributed as bodybuilding dietary supplement products when they illegally contain synthetic steroid substances.
"[Criminals] take chances and take risks and perceive there won't be consequences. The FDA's recent actions shows that's not the case," Dr. Shao said. He applauded the warning as the kind of enforcement of which the industry needs to see more.
The New York Times also reported on FDA’s action, including comments from Dr. Shao in its article. “The overwhelming majority of dietary supplements are made by reputable manufacturers that ensure the products are safe,” he said.
CRN shares outlook on supplements, healthcare reform
A July 27 article in the Tan Sheet discusses legislation that seeks space for supplements as part of the push for health reform. CRN’s Mike Greene observed there are myriad ways for nutritional products to find their way into health care reform.
"There is no specific dietary supplement vehicle" for cracking the legislative agenda, Mr. Greene is quoted, adding that CRN would like to see the healthy living ideals of its “Life...supplemented” campaign codified in law. That is, a lifestyle built on the three pillars of health—healthy diet, supplements and exercise.
Still, Mr. Greene explained in the Tan Sheet, CRN prefers that supplements enjoy the same fiscal benefits that characterize other medical products and procedures.
"It's very difficult to read the tea leaves on these legislative proposals," he said. "I think as long as it accomplishes the final goal of providing Americans the tools to purchase the supplements they want and deduct them from their flexible spending accounts, then CRN would support that."CRN comments on FDA search for steroids in supplements
“…there's an awful lot of regulation in this industry and to say there isn't, that's false,” CRN’s Steve Mister is quoted in an Associated Press article on an FDA special agent’s targeting a company allegedly selling steroids under the guise of a supplement. Indeed, the very FDA action discussed in the article points to the agency’s enforcement authority to regulate supplements. CRN’s Judy Blatman was also quoted in the article, observing, “…if a company is putting steroids in a product, it's an adulterated product, an unapproved drug, but it's not a dietary supplement."
Publication of ‘Life…supplemented’ study highlighted
“It may be surprising that physicians and nurses are as likely as the general population to use supplements given the negative views sometimes expressed editorially in medical journals," according to CRN’s Andrew Shao, CRN past president Annette Dickinson and Ipsos Public Affairs vice president Nicolas Boyon, authors of a study newly published in Nutrition Journal, and covered in a Tan Sheet item. The Tan Sheet reported, “a peer-reviewed study in the July 1 Nutrition Journal finds 72 percent of physicians and 89 percent of nurses use supplements, and 79 percent of physicians and 82 percent of nurses recommend them to patients. The study, which showed multivitamins were most commonly used, examined data from the Council for Responsible Nutrition's ‘Life...supplemented’ Healthcare Professionals Impact Study.”
CRN pushback against USADA inaccurate comments noted
An article in the Tan Sheet headlined “CRN Stands Up Against U.S. Sports Official's Criticism Of Supplement Quality” recounted the association’s comments to U.S. Anti-Doping Agency CEO Travis Tygart following his mischaracterization of supplements during a presentation before the National Association of Attorneys General last month. The Tan Sheet noted, “The supplement industry has been a frequent punching bag for athletes blaming tainted nutritionals for their performance-enhancing drug violations, but the Council for Responsible Nutrition is countering accusations by the head of the U.S. group that tests Olympic athletes.”
The Tan Sheet outlined CRN’s multifaceted rebuttal to Mr. Tygart’s comments and quoted association president Steve Mister who pointed to a European group that reported more than 90 percent of the 11,000 athletes competing at the Beijing Summer Olympic Games in 2008 used supplements, but "there were relatively few allegations" of tainted products.Science and Supplements |
Soy proteins lower cholesterol in diabetes patients
A recent study published online ahead of print in the Journal of Nutrition showed soy protein to be beneficial to diabetics in reducing cholesterol, a strong risk factor for cardiovascular disease, itself strongly associated with diabetes.
Researchers from the University of Guelph and colleagues studied 29 adults with type-2 diabetes who were not taking lipid-lowering medication using a cross-over design. In the first 57-day supplementation period, participants were randomly assigned beverage powders containing either 80 mg per day soy protein isolate (isoflavone content: 52 mg genistein, 24.8 mg daidzein, and 3.2 mg glycitein) or milk protein isolate. After a 28-day washout period, participants were assigned another 57 days of the treatment they had not received previously. During the study, participants maintained their typical diet, but were instructed to avoid foods such as soy products, beans and legumes, to minimize exposure to isoflavones from other sources besides the soy protein supplement. Blood samples were assessed for changes in serum lipids, including LDL and HDL cholesterol, and levels of the lipid-binding proteins apo B and apo A-1. LDL cholesterol was significantly reduced (6 percent) following soy protein compared with milk protein (3 percent). Although HDL cholesterol, apo B and apo A-1 levels did not significantly change, the ratios of LDL to HDL cholesterol and apoB to apo A-1 significantly decreased following soy protein consumption compared with milk protein. These effects suggest a preventative role for soy isoflavones in diabetes-related cardiovascular disease. See the Research Watch section of CRN's Members Only website for more information on this and other studies.Iodine supplementation boosts babies’ development
Preliminary findings from a recent study suggest iodine supplementation during pregnancy and lactation may benefit infant development. According to the study, women who took 300 mcg of potassium iodine daily had children whose psychomotor skills were more developed than those children born to mothers who had not received iodine supplements. A total of 194 pregnant women who attended the same hospital in Osuna, Spain, were included in the study. The 133 women in the iodine group started supplementation in the first trimester of pregnancy and continued through lactation (average was four months). The 61 control subjects enrolled in the hospital during the last month of pregnancy did not receive iodine supplements.
Infant children were 3 to 18 months old when their cognitive and psychomotor development were evaluated by researchers using the Bayley Scales for Infant Development. The similar mental development index (MDI) values indicate that the children’s cognitive development, for example, sensual and perceptual acuities and ability to respond to stimuli, were comparable regardless of whether their mothers took iodine supplements or not during pregnancy. However, the psychomotor development index (PDI), a measure of body control and motor coordination, was greater in children whose mothers received 300 micrograms per day of iodine. Researchers also noted that children of mothers who were in the iodine group exhibited behaviors on level with their age group compared with children of the mothers in the control group, based on qualitative assessment of items on the Behavior Rating Scale. The study was published online ahead of print in the Journal of Clinical Endocrinology & Metabolism. See the Research Watch section of CRN's Members Only website for more information on this and other studies.
| CRN Calendar |
August 3
Seminar for Supplement Regulators
Manila, Philippines
—Hathcock (presenting)
August 3–5
Retail Physicians Education Congress
Orlando, FL
—MacKay (presenting)
August 4
IOM Committee Meeting to Review DRIs for Vitamin D and Calcium
Washington, DC
—Nguyen
August 4–5
USP Stakeholder Forum on Food Ingredients (August 4) and Dietary Supplements (August 5)
Rockville, MD
—Shao
August 5
"Life…supplemented" Steering Committee Conference Call
—Blatman, Hlasney, Solorio, Murphy
August 6
SIDI Working Group meeting
Washington, DC
—Shao; Nguyen
August 19–22
24th Annual American Association of Naturopathic Physicians Convention and Exposition
Tacoma, Washington
—MacKay
August 25–26
7th Annual Covance Food Symposium
Madison, WI
—Shao (presenting)
September 11
Dietary Supplement Law Symposium
Salt Lake City, UT
—Mister; Greene (presenting)
September 13–16
AOAC Annual Meeting & Exposition
Philadelphia, PA
—Shao
September 14
Media Relations Committee Conference Call
—Blatman, Solorio, Hlasney, Murphy
September 15
Dietary Supplement Caucus Briefing
Washington, DC
—Greene; Lebert
September 16
In-person Government Relations Committee meeting
Washington, DC
—Greene; Lebert
September 17
Health & Beauty Expo
New York City, NY
—Mister (presenting)
September 23–25
Natural Products Expo-East
Boston, MA
—Shao (moderating)
October 21
The Workshop: CRN’s Day of Science
Rancho Palos Verdes, CA
October 21–24
The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry
Rancho Palos Verdes, CA