Industry attacks McCain Bill for “regulatory overkill”
Industry groups and legal experts have condemned the Dietary Supplement Safety Act of 2010 as an unnecessary threat to existing legislation that is already empowered to ensure dietary supplements in the United States are safe.
The Council for Responsible Nutrition (CRN); Natural Products Association and the American Herbal Products Association (AHPA) all issued statements criticizing the Bill. —Introduced by Republican Senator John McCain of Arizona and Byron Dorgan of North Dakota the Bill seeks to amend the Federal Food, Drug, and Cosmetic Act, “to more effectively regulate dietary supplements that may pose safety risks unknown to consumers”. Industry has attacked it for being motivated by false premises such as an over-estimation of the problem of sports contamination, and for stepping on the toes of a regulation (the 1994 Dietary Supplements and Health Education Act) that already provided measures to address the issues raised by the Bill. —“This bill is not only unnecessary, it is regulatory overkill,” said Virginia-based attorney, Jonathan W Emord. –It requires companies to report non-serious adverse events to the Food and Drug Administration (FDA); gives immediate recall rights over products suspected of contamination; creates an Accepted Dietary Ingredients list in place of New Dietary Ingredients provisions and demands all facilities to register on a list annually.
Robust enforcement needed
The founder executive director of the American Botanical Council, Mark Blumenthal, added adequate implementation of DSHEA was required, not a new set of regulations that will do little to address the problems at hand. –“It is understandable why legislators and others might feel the need to hold hearings and propose additional legislation to attempt to prevent or correct some of the problems in the dietary supplement industry,” he said. –“This includes the need to address problems of poor quality, intentional adulteration, exaggerated and unsubstantiated claims, and other excesses that exist in some pockets of the industry.” —He said the fact DSHEA had not in 15 years been, “adequately, uniformly, fully, and robustly enforced” fuelled the creation of such a Bill, but observed, “what is really needed is robust enforcement of existing laws and regulations, not more laws.” —A host of major sporting bodies including the National Football League (NFL) and Major League Baseball (MLB) have thrown their weight behind the Bill after Senator McCain said one of the motivations for introducing it was to combat contamination of sports supplements. —“[The Bill] places new burdens on dietary supplements that are not required for any other class of food,” said Michael McGuffin, president of the American Herbal Products Association (AHPA). —“And at least in the case of the proposed policing responsibility for retailers, it appears to be more stringent than retailer requirements under current drug laws.”
Daniel Fabricant, PhD, the NPA’s vice president for scientific and regulatory affairs, said the current political climate in Washington made it difficult to predict how the Bill might be received on Capitol Hill. —“I think such a bill has a better chance of being tacked onto another bill as a floor amendment than being a standalone piece of legislation, so it will be monitored accordingly,” he said, noting industry had to respond to the challenge and up its efforts in defense of DSHEA. —He defended the industry against the scapegoating that has gone on from the likes of professional athletes and associations that have blamed certain transgressions on dietary supplements when other factors may have been involved. “Let us not forget that a number of athletes have lied or withheld information on their steroid use when they testified in front of both the house and senate,” he told NutraIngredients-USA.com. —-“The sporting leagues’ failures to correct their drug testing policies should have no affect on the millions of Americans who safely and successfully use a supplement daily.”
You cannot be serious
On the matter of non-serious adverse event reporting (AER), CRN president and chief executive officer, Steve Mister, said an obligation to report non-serious AERs could be counterproductive as it may stretch FDA resources beyond breaking point. —“The best way to help consumers is through collaborative efforts with industry, government and other stakeholders, such as USADA (US Anti-Doping Agency), to implement the current laws, to provide more resources and funding to FDA, and to pass the food safety bill, which already includes many of these provisions,” he said. —Emord said a requirement to report non-serious adverse events was “laughable”–“If it is not serious why bother?” he wondered, noting ‘seriousness’ had not been defined. “Is it when the vitamin bottle drops to the floor and the cat eats every one?” —We are now likely to have a deluge of filings to the FDA, inundating it with non-serious junk mail that will overwhelm it and render it difficult to find all serious adverse event reporting.” —He added: “I think it is fair to say that this bill is Orwellian. It is more like 1984 than anything a Democratic member of Congress has produced. John McCain has outflanked his most liberal Democratic counterparts.” —USADA CEO Travis T Tygart stated: “The McCain bill is a fair and balanced approach that provides significant protections for all consumers of dietary supplements, while at the same time avoids placing unreasonable burdens on legitimate companies in the industry. We are grateful to Senator McCain for his strong leadership on this public health issue and urge other members of Congress to support this bill.”
Senators McCain and Dorgan Betray Dietary Supplement Consumers
On Thursday, Feb. 4, 2010, Senators John McCain (R-AZ) and Byron Dorgan (D-ND) introduced The Dietary Supplement Safety Act (DSSA) of 2010. This bill would amend DSHEA and undermine, if not entirely eliminate, consumer access to valuable dietary supplements, according to Jim Turner, Citizens for Health Board Chair.—Over the next week, Citizens for Health will report in detail on specific sections of the bill, which would:
· Reverse the 100-year long status of supplements as foods;
· Create onerous requirements for supplements not applied to other foods or even to prescription drugs; and
· Wipe out significant numbers of small supplement manufacturers and sellers.
“This bill, typical of Washington’s ‘destroy the economy, wipe out consumer rights, and undermine individual health’ mentality,” says Turner, “thoughtlessly reinforces the costly, unresponsive, dangerous policies that have created an unsafe and depleted food supply and a bankrupt health care system.”–This bill takes power, choice, and self-determination from consumers and gives it to government. Urge your Senators to avoid co-sponsoring it. The people of Arizona and North Dakota, who believe in consumer rights, safe and healthy food, and responsible government, deserve better Senators. McCain and Dorgan are up for re-election this year – and if this bill passes, voters will line up to set them straight in November.–Stay tuned to http://www.citizens.org for further developments, and enter your email address to receive our blog posts on issues of importance to the natural health and wellness community.—James S. Turner is a partner in the Washington, DC, law firm of Swankin and Turner, formed in 1973, and Board Chair of Citizens for Health, the consumer voice of the natural health community. From 1968 to 1971, Mr. Turner worked with Ralph Nader, and wrote The Chemical Feast: The Nader Report on Food Protection at the FDA (Grossman 1970).—In 1975, he successfully opposed the Federal Trade Commission proposal to ban the words “natural,” “organic” and “health food” from all commerce. In 1990, he lobbied successfully-with many others-for passage of the “Organic Food Production Act of 1990”. In 1994, he worked with the newly created Citizens for Health to pass DSHEA. Congress received one and a half million communications supporting DSHEA.—Turner also led the team that persuaded FDA to approve acupuncture needles (1996); campaigned successfully against the 1976 Swine Flu program, which the government stopped for being dangerous; lobbied successfully for the Nutrition Labeling and Education Act of 1990, which legalized health claims for food; and wrote Making Your Own Baby Food (Workman 1974, Bantam 1975, 2nd expanded edition Workman 1976).
Melatonin Precursor Stimulates Growth Factor Circuits in Brain
ScienceDaily (Feb. 5, 2010) — Scientists at Emory University School of Medicine have discovered unexpected properties for a precursor to melatonin, the hormone that regulates sleep cycles.–Melatonin is produced from the neurotransmitter serotonin in a daily rhythm that peaks at night. Melatonin’s immediate precursor, N-acetylserotonin, was not previously thought to have effects separate from those of melatonin or serotonin.—Now an Emory team has shown that N-acetylserotonin can stimulate the same circuits in the brain activated by the growth factor BDNF (brain-derived neurotrophic factor).—The results will be published online this week in the Proceedings of the National Academy of Sciences.—The team was led by Keqiang Ye, associate professor of pathology and laboratory medicine, and P. Michael Iuvone, professor of pharmacology and director of research at Emory Eye Center. Researchers from Morehouse School of Medicine and the University of Wisconsin contributed to the paper.—The discovery has implications for the study of how some antidepressants function and may also explain previous observations that N-acetylserotonin has antidepressant activity in animal models of depression.—“Our results suggest that the molecules and pathways involved in mood regulation and circadian rhythms are intertwined,” Ye says.—A lack of BDNF, which pushes brain cells to grow and helps them resist stress, is thought to lie behind depression and several neurodegenerative diseases. Ye and his colleagues have been searching for chemicals that can mimic BDNF by activating TrkB, the receptor for BDNF on cells’ surfaces.—Several widely prescribed antidepressants (selective serotonin reuptake inhibitors such as fluoxetine/Prozac) increase levels of serotonin in the brain, but the connections between serotonin levels and depression are complex. Because antidepressants seem to take weeks to display their effects, scientists have proposed that their real targets are BDNF and TrkB.—“We were exploring whether the serotonin system is involved in TrkB signaling,” Ye says. “We were surprised to find that N-acetylserotonin, but not serotonin or melatonin, can activate TrkB.”—N-acetylserotonin could stimulate TrkB even when BDNF was not present, both in cell culture dishes and in mice, Ye and his colleagues found. It could also protect neurons from overstimulation in the same way that BDNF can.—-Melatonin is produced at several sites in the body: the pineal gland, the retina and the intestine. One of the most common strains of laboratory mice (C57Bl6) is deficient in making N-acetylserotonin and melatonin and develops retinal degeneration.—The authors observed that in the retinas of mice that produce adequate melatonin, TrkB is turned on at night, a pattern that matches the appearance of N-acetylserotonin. However, the pattern of TrkB activation is flat in C57Bl6 melatonin-deficient mice.—Ye’s laboratory is now investigating the mechanism by which N-acetylserotonin activates TrkB. He says that N-acetylserotonin has a short lifetime in the body but similar compounds that are more stable may be useful in treating neurological diseases.–The research was supported by the National Institutes of Health and Research to Prevent Blindness.—Story Source:-Adapted from materials provided by Emory University. Original article written by Quinn Eastman