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CRN responds to ‘Supplement Safety Now’ initiative “We share the concerns of Travis Tygart (USADA Executive Director) and his colleagues at Major League Baseball, the National Football League, and a coalition of other organizations, about rogue companies that sell illegal drug products labeled as dietary supplements,” said CRN’s Steve Mister in a statement issued by the association on “Supplement Safety Now,” an initiative launched by the U.S. Anti-Doping Agency (USADA) and a coalition of other organizations.Mr. Mister added, “This kind of criminal activity is dangerous to consumers and also negatively impacts the overwhelming majority of dietary supplement companies that are committed to following the laws.” CRN commended USADA and its coalition for stepping forward to find ways to get these illegal products removed from the marketplace and offered to partner with these organizations on ‘Supplement Safety Now’ in those areas in which the association can find common ground with the USADA coalition. CRN purposefully noted that the current regulatory framework is more than adequate to support the objectives of ensuring consumers’ access to safe supplement products, but acknowledged there were potential enhancements to the law it could support. CRN further emphasized in its statements and in media interviews that FDA needs more resources to enforce laws already on the books before laws need to be rewritten. Read more in CRN in the News. CRN reaches out to Boston Globe As part of the association’s rapid response program, CRN last month arranged for an editorial board meeting via conference call with the Boston Globe. Responding to an editorial in the Globe, “Police These Pills and Powders,” which advised that “The U.S. Food and Drug Administration is virtually powerless in regulating the $25 billion dietary supplements industry,” CRN provided factual information on supplement regulation to set the record straight. CRN’s Steve Mister and Andrew Shao spoke for 30 minutes with the editorial board reporter, explaining how the Dietary Supplement Health and Education Act (DSHEA) works and why the law is the appropriate framework for regulating the dietary supplement industry. In addition to participating in the meeting, CRN was the first industry representative to post a comment on the newspaper’s website in response to the story when it first ran. Contact Erin Hlasney (202-204-7684). CRN responds to vitamin B study The findings of a recent study on B vitamins do not nullify the potential long-term benefits that folic acid fortification may have on the population’s health, CRN stated, agreeing with an editorial in the Nov. 17 issue of the Journal of the American Medical Association (JAMA) that accompanied study results on “Treatment with Folic Acid, Vitamin B12 Associated with Increased Risk of Cancer, Death.” CRN was ready pre-embargo with talking points and a standby statement in response the study, sharing information with member companies, and strategically reaching out to select press contacts. As anticipated, the study received only moderate pick-up in national media outlets with relatively balanced coverage. CRN’s perspective was included in WebMD’s coverage, as well as in trade publications. In most other consumer coverage, an academic or health expert was quoted, reminding the public of the larger body of scientific evidence supporting the importance of folic acid. CRN emphasized that these latest results are inconsistent with the existing body of evidence on B vitamins, that lung cancer rates have gone down overall during the period since folic acid fortification has been mandatory, and that the results do not readily apply to the general population because the study was done on heart-disease patients, the majority of whom were smokers. “For consumers, the most important message is that they should continue to feel confident in the safety and efficacy of consuming the recommended amounts of folic acid as part of an overall healthy lifestyle." Read more in CRN in the News. CRN comments on NCCAM’s influence on research, healthcare professionals and consumers “CRN would like to see NCCAM display greater leadership in the investigation of new research methods designed to explore the complexities of [complementary and alternative medicine] therapies and overcoming the methodological challenges presented by the very nature of these therapies,” CRN’s Duffy MacKay wrote in comments to the National Institutes of Health’s National Center for Complementary and Alternative Medicine (NCCAM) on its strategic plan for the next five years. NCCAM is developing its third strategic plan and called for public comments on three background papers covering mission, priority setting, and communications/decision-making, which will support the development of this plan. “The CAM research community needs clear criteria and guidelines for how best to study effects of nutrients and other naturally occurring bioactive compounds in humans, and subsequently how to evaluate those findings…NCCAM should be an integral part of high level discussions and investigations of whether it is appropriate to apply a drug-based research paradigm to assess nutrient and CAM-related questions,” Dr. MacKay noted, emphasizing “the definition of rigorous scientific investigation should not be limited to reliance on the conventional randomized controlled trial (RCT) as the single gold standard.” CRN’s comments addressed the center’s specific requests for information, touching on NCCAM’s key areas of influence—research, healthcare practitioners and consumers. “When a consumer who lacks medical and scientific knowledge is faced with a medical condition, they are interested in fair and balanced information about ALL of their health care choices. Consumers desire the ability to compare the potential benefits, risk, costs, resulting quality of life, and personal commitment that accompanies each choice,” Dr. MacKay wrote. “NCCAM should place a greater emphasis on the accurate communication of information about CAM, in context with other health care options available to consumers…To assist the general public make informed choices about their healthcare decisions, it is imperative the public is aware of the impact a particular therapy will have on their quality of life.” Read more in CRN in the News. Contact Duffy MacKay for more information (202-204-7664).CRN reports from AHA scientific meeting Omega-6 and omega-3 polyunsaturated acids can both play a role in improving heart health; weight-loss supplements aren’t all bad; vitamin intake can make a difference in cardiovascular disease; and randomized control trials (RCTs) may not be the best way to determine any of these findings—all this, CRN reported from sessions heard at the American Heart Association (AHA) Annual Scientific Symposium, held last month in Orlando, Fla. CRN’s Season Solorio and CRN consultant Annette Dickinson, Ph.D., attended the meeting due to concerns that there would be controversial sessions on vitamin research. Overall, Ms. Solorio and Dr. Dickinson found the sessions to be balanced and non-sensational, with many conclusions supporting the use of dietary supplements to promote heart health. The question of RCTs was spotlighted in a session entitled “Vitamins and Cardiovascular Disease: Panacea or Placebo?” In her presentation, “Multivitamins: Once a Day or None a Day” JoAnn Manson, M.D., Dr.P.H., noted that there are not large-scale RCT results on multivitamins, other than the Physicians Health Study (PHS II), in which the multivitamin arm is currently ongoing for another 2-3 years. “As such, we have had to rely on observational data and smaller RCTs of combinations of supplements to study multivitamins,” she said. Dr. Manson asserted that the majority of observational studies on multivitamins have shown no effect in preventing heart disease, citing the Women’s Health Initiative study as an example, and conceding that some have shown benefit. She noted that we must be aware of the potential for bias when interpreting these observational studies, particularly because subjects who take multivitamins tend to also have other healthy habits which may be obscuring the benefits of multivitamins. This, she said, is one reason RCTs may be needed. Another perspective on the RCT issue came from Dariush Mozaffarian M.D., Dr.P.H., a presenter on epidemiology in the “Antioxidant Supplements: Lessons Learned” session, who spoke about how observational studies have shown a benefit from antioxidant supplementation, while RCTs have not. Some of the potential explanations for this inconsistent evidence, he noted, include: insufficient duration of treatment in RCTs (a few years versus a lifetime); the wrong populations being studied in RCTs (too sick, too late); the different effects of a healthy diet as compared with effects of supplementation; residual confounding in observational studies (RCTs are right, cohorts are wrong); or none of the above and it’s just more complicated than we thought. For more information, contact Season Solorio (202-204-7682). Follow ‘Life…supplemented’ on Twitter “Life…supplemented,” the CRN-managed consumer wellness campaign that celebrates the more than 150 million Americans who use supplements, is now tweeting on Twitter. Part of the campaign’s Year Three social media mix, “Life…supplemented” will tweet to motivate people to take simple steps to help them move up the wellness scale. In late December, the campaign will launch “America’s Wellness Challenge”—beginning with a 60-day sweepstakes with a grand prize of $15,000—and the industry will be encouraged to tweet about the effort. Sign up now to follow “@wannaBwell” (http://twitter.com/wannabwell) on Twitter. Contact Judy Blatman (202-204-7680) for more information.CRN president addresses omega-3 group “Omega-3s are a ‘halo’ for the dietary supplement industry, but responsible stakeholders must be diligent in protecting against threats from within the industry to the integrity of the category,” CRN’s Steve Mister said in a Nov. 12 presentation to the Global Organization for EPA and DHA (GOED)—an outgrowth of the former CRN omega-3 task force. Mr. Mister underscored the large body of rigorous research, well-demonstrated benefits, buy-in from healthcare professionals, and track record of quality manufacturing that make omega-3s such a strong sector for the industry. He challenged the group to continue to responsibly market their products, emphasizing the importance of maintaining the highest manufacturing standards, investing in research to maintain the integrity of their claims and capitalizing on opportunities to be part of the larger supplement industry. “There is political strength in numbers,” he explained. “Relationships in Washington, D.C. matter and joining the larger industry trade associations is a great way to build key connections.” Mr. Mister’s address was made at the request of GOED’s executive director. CRN well-represented at SupplySide West CRN’s Steve Mister and Andrew Shao both spoke at last month’s industry trade show and educational conference SupplySide West, in Las Vegas, Nev. Mr. Mister, who spoke about legislative developments in Congress, was part of the State of the Industry panel along with other trade association executives. In his presentation, Mr. Mister gave an overview of industry hot topics including: new food safety legislation currently being considered by Congress; the Congressional Subcommittee on Crime & Drugs hearing on steroids and supplements; health care reform; and CRN’s work with the Congressional Dietary Supplement Caucus. In addition, Mr. Mister discussed CRN initiatives including: the advertising review program with the National Advertising Division of the Council of Better Business Bureaus; the Standardized Information on Dietary Ingredients (SIDI) protocol; and the “Life…supplemented” consumer wellness campaign. CRN’s Andrew Shao participated in an educational panel on good manufacturing practices (GMPs), highlighting the most important areas of the GMP regulations and providing recommendations for those companies that are required to follow the regulations and are likely to face an audit. He explained in his presentation that the major areas of concern in GMPs are recordkeeping, analytical methods and supplier qualification. Regarding supplier qualification, he discussed FDA's expectations, and highlighted the SIDI initiative bringing together various trade associations and industry members. Read more in CRN in the News. CRN outreach to state attorney general results in improved information for consumers Following a May meeting with the Maryland Attorney General’s (AG) office, CRN has been working with AG staff to correct erroneous information about dietary supplements that had been posted to the MD AG’s consumer information website. The AG has now updated, corrected or removed the patently misleading and outdated material regarding dietary supplements. For example, the website now correctly recognizes that dietary supplements are, in fact, regulated by FDA. In addition, the publication “Dietary Supplements: Do They Help? Do They Hurt?” has been removed entirely. Although the information that remains still espouses some less than favorable information about dietary supplements, consumers who visit the site will get a more accurate, more balanced viewpoint. CRN’s Steve Mister thanked the AG office for its efforts saying, “I believe the changes more accurately illustrate expectations of dietary supplements; educating consumers about responsible industry, while also advising caution towards unscrupulous products.” Contact Ingrid Lebert for more information (202-204-7699). CRN scientist to serve on natural medicine publication advisory board CRN’s Duffy MacKay has accepted a request to serve on the editorial board of the Natural Medicine Journal, the official journal of the American Association of Naturopathic Physicians. As an advisor, Dr. MacKay will review approximately four papers and submit one of his own over the course of a year. The Natural Medicine Journal provides scientifically valid, patient-centered health care information to the medical community. The journal provides re-caps of the most recent relevant human clinical trials on some form of natural medicine (herb, nutrient, or modality) along with commentary regarding clinical relevance. Contact Duffy MacKay for more information (202-204-7664). CRN, other stakeholders to meet with FDA on AER fine points On Dec. 10, CRN’s Andrew Shao will attend a meeting with FDA, along with several representatives of CRN member companies, and other stakeholders, where the agency will discuss its approach used to evaluate the safety information on Hydroxycut products that led to the agency’s May 1 product warning and subsequent voluntary recall by the company. The meeting was requested by dietary supplement industry stakeholders who have expressed the desire to better understand the agency’s determination of when and how a dietary supplement is considered a serious safety hazard, particularly given the relatively few serious adverse events received in comparison to the overall usage of the products. CRN will report any relevant news from the meeting. Contact Andrew Shao for more information (202-204-7660). CRN to hold member webinar on social media Advertising, public relations and regulatory affairs executives—and other interested company representatives—should block their calendars to participate in a CRN members only Webinar on social media. CRN’s Duffy MacKay will present need-to-know information regarding the Federal Trade Commission’s recently updated guidelines on the use of endorsements and testimonials in advertising as it relates to social media (blogging, Tweeting, viral marketing, etc.). In addition, Kelly Sakalas, from CRT/tanaka, the public relations agency executing CRN’s Life…supplemented consumer wellness campaign, will provide information on the campaign’s foray into social media and offer suggestions as to how companies can energize and engage their own customers to participate. The free webinar takes place Jan. 7 from 2:00–3:15 p.m. eastern time and RSVPs will be required. For more information (or to RSVP) contact Judy Blatman (202-204-7680).
Harkin names HELP aides Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Sen. Tom Harkin (D-IA) today announced key appointments to the committee. Dan Smith will serve as staff director, and Pam Smith, no relation, will serve as deputy staff director. Dan Smith, a former aide to Sen. Harkin, was president of the American Cancer Society's Cancer Action Network. Pam Smith had been Sen. Harkin's legislative director. The two will start their new jobs in January. Sen. Harkin took over the committee after the death of Sen. Edward Kennedy, D-Mass., in August. HELP moves FDAFSMA along, supplements exempted The FDA Food Safety Modernization Act (FDAFSMA)—S 510—passed out of the Senate Committee on Health, Education, Labor and Pensions (HELP) last month, with industry stakeholders appreciative of the inclusion of key language detailing controls already in place for dietary supplements. The bill noted that “Nothing in the amendments made by this section shall apply to any dietary supplement that is in compliance with the requirements of” the FDA-issued good manufacturing practices (GMPs). CRN previously announced its support of the bill, with CRN President 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.” The Senate bill now moves to the full Senate floor for a vote (date unknown as of press time). If passed, it will go to conference with the House of Representatives’ version of food safety, HR 2749, passed prior to the August recess. Contact Mike Greene for more information (202-204-7690).
Counsel provides Reportable Food Registry regulation update Manufacturers of supplements or foods that test an incoming raw material and determine it is contaminated with a pathogen and refuse or return that raw material are not required under the statute to submit a report to the Reportable Food Registry, according to a legal opinion CRN has received from its counsel, Covington & Burling. In this circumstance, a manufacturer meets neither the definition for “responsible party” nor does the rejected raw material meet the definition of a “reportable food.” However, the supplier or vendor that provided the contaminated raw material may be considered a “responsible party” and that raw material may be considered a “reportable food,” such that the supplier may be required to submit a report. CRN’s Andrew Shao observed, “Certainly from a practical standpoint, if a manufacturer identifies raw material contaminated with pathogens, it may want to notify FDA anyway, in addition to telling the supplier. Similarly, if suppliers learn that some of their product has turned up contaminated, they too may want to notify FDA in addition to all their customers.” The new Reportable Food Registry requirements are part of the Food and Drug Administration Amendments Act (FDAAA) of 2007. FDA issued a final guidance—Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007—but some clarification on issues is still needed. CRN is awaiting word from FDA on its interpretation of this potential requirement for suppliers to submit a report. CRN recommends that members watch closely for updates on this issue and will provide further updates through the Regulatory Affairs Committee as information becomes available. Contact Andrew Shao for more information (202-204-7660). NCCAM holds 10th anniversary science symposium The National Institutes of Health’s National Center for Complementary and Alternative Medicine (NCCAM) is holding it 10th Anniversary Research Symposium: Exploring the Science of Complementary and Alternative Medicine on Dec. 8. According to NCCAM, since its inception in 1999, it has addressed the need to examine CAM approaches through the scope of rigorous scientific research and has supported more than 2,200 research projects at scientific institutions across the United States and around the world. This symposium will highlight advances in the field of CAM research. The meeting is open to the public and will be videocast at videocast.nih.gov.
CRN reports from ASEAN science meeting CRN’s John Hathcock participated in the Association of Southeast Asian Nations (ASEAN) Technical and Scientific Committee (ATSC) meeting in Siem Reap, Cambodia, Nov. 23-25 and follow up discussions with the regulatory authorities on November 26-28. The ATSC approved continuation of the current approach to the establishment of maximum values for vitamins and minerals, overriding concerns expressed by representatives of Indonesia and Singapore. Especially important—the ATSC approved the use of U.S. or European Union intake data, rather than waiting indefinitely for the establishment of ASEAN intake data. According to Dr. Hathcock, “Indonesian representatives seem to have accepted CRN’s explanations of the Codex vitamin, mineral and food supplement guideline, but now question whether the tolerable upper intake level (UL) values can be applied to mixtures of nutrients (such as multivitamins).” CRN will help the ASEAN Alliance of Health Supplement Associations (AAHSA) with a written explanation. Dr. Hathcock continued on to Tokyo, Japan, following the meeting to continue his discussion of the basis and common interests in the cooperative agreement initiated last year between CRN and Japanese officials, and presented a brief update on the progress on ASEAN harmonization on health supplements and traditional medicines. Contact John Hathcock for more information (202-204-7662). CRN shapes EFSA discussions on data for setting maximums The European Food Safety Authority (EFSA) held a colloquium on “What’s New in Novel Foods” in Amsterdam, Netherlands, on Nov. 19 and 20. CRN’s John Hathcock participated in a plenary group that discussed estimation of intakes of specific ingredients in relation to the possible need to establish maximum permissible concentrations of daily intakes. At CRN’s urging, the discussion group and the final plenary session acknowledged the validity and current use (in Europe) of surrogate data when population specific data are not available. Dr. Hathcock explains, “This report will be useful in setting a precedent for the Association of Southeast Asian Nations (ASEAN) to proceed with establishing maximums through use of the current tolerable upper intake level (UL) values and U.S. or European estimates of daily intakes of vitamins and minerals, rather than waiting until ASEAN data are available and continuing to use RDA-based maximums in the interim. Contact John Hathcock for more information (202-204-7662). CRN provides science-based regulatory information to transitioning Brazil CRN’s Andrew Shao participated in a Regulatory Workshop held by the International Alliance of Dietary Supplement Associations (IADSA) in Brasilia, Brazil on Nov. 24. The workshop, held in the nation's capitol, was organized to coincide with the Brazilian government's efforts to update regulations for food supplements. The audience included academic scientists, representatives from Brazil's regulatory agency (ANVISA), and industry representatives. A nearly 20-year-old provision which limits the maximum dose of vitamins and minerals in food supplements to the value designated as the Recommended Daily Allowance (RDA) is one of the regulations CRN considers outdated. Dr. Shao gave a presentation on the basis and application of nutrient risk assessment for the purpose of establishing tolerable upper intake levels (UL) and regulatory maximums. He argued that just as it is done for benefit, risk (or safety) must be based on sound science—not arbitrary values. “Risk assessment is a globally accepted, science-based approach for establishing ULs and maximums, whereas RDA-based maximums are not,” Dr. Shao explained. He further provided recent examples of risk assessments published by himself and CRN colleague John Hathcock, including analyses of vitamin D and coenzyme Q10. Other presenters included representatives of the Brazilian food supplement trade association (ABIAD), an academic expert from University of Sao Paulo, a representative from ANVISA and Basil Mathioudakis, a Food Law, Nutrition and Labeling official with the European Commission. Contact Andrew Shao for more information (202-204-7660).
CRN responds to USADA supplement initiative “I do find that disturbing, if you're able to buy these kind of products off a Web site like Amazon and those kind of products are clearly illegal in a number of regards,'' CRN’s Steve Mister is quoted in an Associated Press article covering the U.S. Anti-Doping Agency’s (USADA) new “Supplement Safety Now” initiative. "But that means someone's not doing their job if they're not enforcing the law,'' Mr. Mister observed. The article noted that USADA CEO Travis Tygart said he was recently able to go to Amazon.com and buy " a muscle builder that contains a designer steroid. As stated in the article, Mr. Tygart has testified in front of Congress twice in the past three months, endorsing tougher regulations and enforcement for the supplement industry. CRN issued a response to the program’s launch on Wednesday, Dec. 2. Read more in CRN and Its Members at Work. CRN quoted in New York Times on supplement quality CRN’s views were included in a Dec. 4 New York Times article on “Knowing What’s Worth Paying for in Vitamins.” CRN’s Andrew Shao was quoted taking exception to assertions that there is a “quality problem” with multivitamins. Dr. Shao explained that FDA allows for “a reasonable amount of variation”—which he characterized as up to 15 percent more or less of an ingredient than the label might indicate. Usually it is more, Dr. Shao is further quoted, as manufacturers frequently add slightly more of an ingredient to ensure that the amount is at the level claimed on the label as the product nears the end of its shelf life. Dr. Shao also noted the two most commonly used third-party certification groups—the United States Pharmacopeia (www.usp.org) and NSF International (www.nsf.org). Dr. Shao told the New York Times, “Manufacturers voluntarily submit a product for review and, if it passes, the product can bear an approval seal, such as USP or NSF. Because the process is voluntary, the absence of the seal does not necessarily mean the product is of poor quality.”CRN comes out strong with science-based critique of recent vitamin B study conclusions "The real headline of this study should be that smoking increases the risk of lung cancer—the study found that a total of 94% of the subjects who developed lung cancer were either current or former smokers," CRN’s Andrew Shao is quoted in WebMD’s coverage of the study “Cancer Incidence and Mortality After Treatment with Folic Acid and Vitamin B12,” published in the Journal of the American Medical Association (JAMA) Nov. 17. (See story in CRN and Its Members at Work.) Dr. Shao further observed that the fact that lung cancer rates have dropped during the period of time following the mandatory fortification of flour and grains with folic acid in the U.S. suggests folic acid and B12 do not promote lung cancer. Drug Store News also covered the study in an article headlined “CRN challenges folic acid/lung cancer link.” Dr. Shao’s comments on smoking were again highlighted. “For years, the vast body of scientific evidence has shown that individuals who have smoked at any point in their lives are at a significantly increased risk of developing lung cancer. Most health experts would agree that the number one way to prevent lung cancer is to abstain from smoking.” In addition, Drug Store News included Dr. Shao’s critique of the interpretation of the study results. “…the original studies were [treatment] trials involving ischemic heart disease patients—not healthy individuals, and the present publication represents findings from the combined trials on cancer obtained from a secondary analysis—both trials were designed to assess effects on cardiovascular events, not cancer,” He explained. “Therefore, not only is it inappropriate to draw any conclusions from these results, but whatever might be concluded, does not readily apply to the generally healthy population,” Dr. Shao concluded. The Natural Products Insider article further quotes Dr. Shao on the study results, “It is puzzling why patients who were given high doses of folic acid were more likely to develop lung cancer than those subjects in the control group; however, it is important to point out that these results are inconsistent with the larger body of data and that this effect has not been observed previously. In fact, as the authors themselves point out, ‘Epidemiological studies have demonstrated no associations between intakes of folate or folic acid and lung cancer risk.’” Dr. Shao noted in the Nutraceuticals World article on the study that, “Consumers, as well as researchers and healthcare professionals, must not lose sight of the safe, well-established benefits of folic acid supplementation and fortification for women of childbearing age to prevent neural tube defects, as well as other potential benefits of folic acid supplementation, such as for cardiovascular health and cognitive function in the general population.” In an unstable economy, sales of dietary supplements steady, CRN study shows "According to our survey, consumers, including supplement users, report to be taking necessary steps towards good health, such as trying to eat a balanced diet and getting regular exercise," CRN’s Judy Blatman is quoted in coverage from The Independent, citing data from the 2009 CRN Consumer Survey on Dietary Supplements. “We're encouraged that dietary supplements continue to be a part of that equation for many,” Ms. Blatman said. The article noted that “despite unsteady economic times, the market for dietary supplements is still stable, with 75 percent of U.S. adult consumers buying supplements as they used to in pre-recession times (before 2008), and 65 percent (up from 64 percent) of them currently taking dietary supplements.” The Independent further reported that “currently, confidence in supplements is at an all-time high, particularly among women and more affluent individuals, largely because the industry is now supporting Good Manufacturing Practices in response to consumer concern about the safety of many dietary supplements.” CRN discusses FDAFSMA supplement language in trade press coverage CRN’s Mike Greene called language in the FDA Food Safety Modernization Act (FDAFSMA-S 510) “very significant,” in his comments to The Tan Sheet on the bill. FDAFSMA passed the Health, Education, Labor and Pensions Committee (HELP) Nov. 18 with language stating, “Nothing in the amendments made by this section shall apply to any dietary supplement that is in compliance with the requirements of” the good manufacturing practices (GMPs) FDA issued for supplement firms in 2007. Mr. Greene said, “The language clarifies that dietary supplements will be covered under food safety, but also reflects the fact that the GMPs for the supplement industry already include the concepts in the hazard analysis provision, and in some cases the GMPs for the supplement industry are even more stringent.” According to The Tan Sheet, the Senate’s food safety reform bill relieves the dietary supplement industry’s biggest concern about the legislation by explicitly excluding supplement firms from duplicative manufacturing regulations. See story in Hill Happenings. NutraIngredients.com reports on CRN comments to NCCAM “We support NCCAM’s allocation of resources to help the development and validation of biomarkers as modifiable surrogate endpoints for both disease and ‘wellness’,” a NutraIngredients.com article quoted CRN’s Duffy MacKay, from comments submitted to the National Institutes of Health’s National Center for Complementary and Alternative Medicine (NCCAM) on the center’s latest five-year strategic plan. The article noted that in the comments Dr. MacKay said the lack of validated biomarkers meant that regulators don’t regard them as sufficient information on which to base a regulatory decision. But clinical trials conducted using the development of chronic diseases as clinical endpoints are both costly and complex. “NCCAM’s work in exploring other research methodologies as opposed to randomized clinical trials is an important contribution. This involves bringing together (studies of) diet, life-style, supplementation and stress management,” said Dr. MacKay. See story in CRN and Its Members at Work.CRN talks product trends, GMPs at SupplySide West A Tan Sheet article recently highlighted CRN’s support of combination products as noted by CRN’s Steve Mister in his presentation at SupplySide West. (See story in CRN and Its Members at Work.) Mr. Mister called these products “a wonderful opportunity for consumers to bring together this continuum of health care.” He added that “companies have to be really smart and really careful about the ingredients they choose to put together." The Tan Sheet noted Mr. Mister’s concern that FDA’s take on combination products is "short-sighted" as well as his recommendation that companies get creative with the tandems they offer. “Let's think about co-packaging products," he said, offering an alternative. “Don't put them in the same dosage form, but shrink-wrap them together and see what happens." Good manufacturing practices (GMPs) were the focus of discussion from CRN’s Andrew Shao at SupplySide West. “If it’s not written down, it did not happen,” Dr. Shao is quoted, emphasizing the importance of recordkeeping in GMP compliance, in a Natural Products Insider article covering his presentation. Dr. Shao also discussed other major areas of concern in GMPs—analytical methods and supplier qualification. More insights on GMPs from Dr. Shao’s expert perspective are available in his bylined article in Nutritional Outlook on how the GMPs will soon separate the good companies from the bad and why companies must focus on qualifying ingredient suppliers. DSC caucus luncheon discussions on supplements, steroids highlighted in trade press “…let’s make this clear—illegal steroids have no place in dietary supplement products. People who put illegal substances in those products are criminals,” CRN’s Steve Mister is quoted in Nutraceuticals World’s coverage of an educational lunch briefing held on Capitol Hill by the Congressional Dietary Supplement Caucus (DSC) in cooperation with CRN and the Natural Products Association. Mr. Mister made his comments following a presentation from Douglas S. Kalman, Ph.D., R.D. Also covered by NutraIngredients.com, the luncheon included discussion from DSC representatives Jared Polis (D-CO) and Dan Burton (R-IN). Rep. Polis noted the important role dietary supplements play in the diet, citing data from CRN and personal testimonies, saying, “An estimated 150 million Americans, including myself and other members of Congress, use dietary supplements each year.”
High doses of phytosterols shown to help balance cholesterol levels Plant phytosterols may offer benefits for humans when it comes to keeping cholesterol levels in better balance, suggests a study published online in the American Journal of Clinical Nutrition. Moderate and high intakes of phytosterols—about 400 and 2,000 milligrams (mg) per day, respectively—were found to increase the elimination of cholesterol from the body while decreasing absorption of cholesterol in the intestine. These results were reported by researchers from Washington University in St. Louis who conducted a feeding study that involved 18 adults with an average age of 63 years. Participants were randomly assigned to a low phytosterol diet that contained about 50 mg phytosterol per day plus three intakes of supplemental phytosterols (0—control, 400—moderate and 2,000—high, mg per day, respectively) for four weeks using a cross-over design. Each four-week period was separated by a one week washout period. Phytosterols were given in two daily beverages taken with breakfast and dinner. After four weeks, phytosterols at the moderate and high dose significantly increased total cholesterol excretion by 36 and 74 percent, respectively, relative to the control (background diet containing 50 mg phytosterol per day). Intestinal cholesterol absorption decreased by a statistically significant 10 and 25 percent following moderate and high dose phytosterols relative to control diet. Serum LDL cholesterol levels lowered by 5 and 8.9 percent after moderate and high dose phytosterols, reaching statistical significance only for the high-dose phytosterol group. Total cholesterol and non-HDL cholesterol also significantly decreased after intakes of 2,000 mg per day phytosterol relative to control. However, HDL and triglyceride levels were not affected by phytosterol intake at any dose. Phytosterol intake at 2,000 mg per day, a dose that cannot be achieved through the diet alone, provided the most benefits to participants. See the Research Watch section of CRN's Members Only website for more information on this and other studies.
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