March 17, 2010
“The NPA is pleased that industry champions Hatch and Harkin have reached an agreement with McCain and Dorgan on reasonable measures to strengthen the regulation of dietary supplements without opening up DSHEA,” said John Gay, NPA’s CEO and executive director. “The original McCain-Dorgan bill would have radically altered the existing regulatory framework [in the Dietary Supplement Health and Education Act], and threatened an entire industry in an ineffective attempt to combat a relatively few bad actors.”
McCain and Dorgan outlined key areas of “common ground” in a letter to Harkin, Hatch and Sen. Mike Enzi (R-WY), which proposed incorporating the agreed-upon points into the Food and Drug Administration’s (FDA) Food Safety Modernization Bill.
Those provisions include:
• Requiring all dietary supplement manufacturing, processing and holding facilities to register with the Secretary of Health and Human Services;
• Giving the FDA authority to issue a mandatory recall order if a dietary supplement is adulterated or misbranded or “the use of such supplement could cause serious adverse health consequences such as death;”
• Requiring the FDA commissioner to publish guidelines on new dietary ingredients “as soon as possible;” and
• Mandating that the FDA notify the Drug Enforcement Administration when a new product contains a synthetic anabolic steroid.
“NPA is eager to review the agreement’s details,” said Gay. He cautioned that the bill “was a wake-up call for the industry, and we had better not fall back asleep. Other members of Congress could pick up where McCain and Dorgan left off. We need to keep up the pressure on Congress, and let them know that S.3002 and bills like it are not acceptable.”
The United States Anti-Doping Agency (USADA) and Supplement Safety Now (SSN) also gave their support for the agreement.
“The agreement provides much needed additional consumer protections, without risking access to legal supplements,” said USADA CEO Travis T. Tygart. “This is a battle that has been won for the good guys, and we will continue to monitor the impact of these changes while maintaining efforts to hold the supplement industry accountable for ensuring all of their products are healthy and safe for consumers.”
NPA’s Gay added, “Industry advocates should continue to let their senators know their opposition to S. 3002 in order to dissuade other senators or representatives from taking it up.” The NPA asked association members and industry advocates to send messages to legislators through its website at www.NPAInfo.org/TakeAction. NPA also encouraged advocates to attend its upcoming Natural Product Day, March 23, where participants discuss issues affecting the natural products industry with their members of Congress.
“NPA West is broke, it is without any money, it is without any support and it has not met the standards of the NPA national to continue to exist as a region,” explained Stouder. “At the meeting, the closings will be made official unless NPA makes a massive announcement to the contrary.
“The NPA set certain standards to bring the regions into compliance so they would be strong, functioning regions,” added Stouder. “Despite what we tried to do, we were not able to come through in the past several years with support of the NPA West through membership and attendance on the board and at trade shows. For whatever reason, we have never been able to garner widespread support.”
As of press time, a decision had not been made. NPA’s national office confirmed that the status of the West and Rocky Mountain regions will be discussed at the board meeting March 23.
Beginning with this year’s event October 13-16 in Boston, MA, All Things Organic will be the branded organic pavilion for North American organic companies exhibiting at Expo East to distinguish organic businesses from other natural companies at the show. Meanwhile, Organic Products Expo-BioFach America will continue to be co-located at Expo East.
The All Things Organic conference program will be incorporated into the Expo East educational programs as a dedicated organic session track developed by OTA. In addition, OTA’s Annual Meeting will be held at Expo East, and OTA’s Leadership Awards Dinner and Dance will be held October 15 in junction with the co-location. Furthermore, OTA’s International Reverse Trade Mission will help position the event as an international gathering place for organic interests.
New Hope Natural Media, which organizes Expo East, will work with companies that had signed up to exhibit at the All Things Organic 2010 Trade Show originally scheduled in June for Chicago to work out their participation in the new co-location.
The tuxedo was made exclusively for Kenner by New York City-based environmentally conscious fashion brand Loomstate. According to Loomstate, this is the first American-crafted organic tuxedo ever to be made for the Academy Awards. VTOF is the nation’s leading provider of Merino wool fabrics made with wool grown and certified to the US Department of Agriculture’s (USDA) national organic program standard, said the company.
“I loved the tux,” said Kenner, whose film documents the industrialization of the US food supply and the viability of the local and organic sector. “It felt right to be organic and show that both food and textiles can be made in an organic fashion and still be beautiful and excellent quality.”
Loomstate custom designed and handmade the tuxedo using 100 percent organic gabardine twill O-Wool fabric.
For more information about VTOF, call (802) 388-1313 or visit www.vtorganicfiber.com.
The initial defendants in this case are CVS Pharmacy, Inc.; General Nutrition Corp. (GNC); Now Health Group, Inc.; Omega Protein, Inc.; Pharmavite LLC (Nature Made brand); Rite Aid Corp.; Solgar, Inc. and TwinLab Corp. Plaintiffs are conducting more tests and expect to add other companies to the legal action, if and when test results of their fish oil products show levels of PCB contamination that should have been disclosed under California law. Citing California’s Proposition 65, the action is demanding compensation for consumers of $2,500 per person per day exposed to the PCB-containing products. It would also require the companies to place prominent warnings on their products’ labels.
“Consumers who want the health benefits of fish oil shouldn’t also have to take the health risks of an extremely toxic man-made chemical,” said David Roe, one of the attorneys for the plaintiffs. “And they don’t have to, since preliminary test results show that some fish oil brands have only 1/70th as much PCB contamination in them as others.”
According to Adam Ismail, executive director of Global Organization for EPA and DHA Omega-3s (GOED), “We have complete confidence in the safety of the fish oil supplement market, which has been validated through multiple third-party reviews by industry watchdogs on thousands of products. In fact, this industry is among the highest quality and most transparent of all consumer products.”
Supplement industry attorney Mark Ullman added, “The benefits of fish oil are incredibly documented, and the plaintiffs are making you think that they’re trying to serve the public; but in reality, they’re trying to needlessly scare the public and collect damages.”
The impact would be economically disastrous, Ullman said.
The lawsuit claims that these supplements have PCB contamination above the so-called “safe harbor” limits set for human PCB consumption under California’s Proposition 65. That law requires consumers to be warned about such exposures. Proposition 65, passed as a ballot initiative by a 2:1 margin in 1986, has a consistent history of forcing consumer products to eliminate toxic chemical ingredients or reduce them below published “safe harbor” limits.
“While looking at the industrial fishing operations of controversial Omega Protein, we found that the industry seems very aware that fish oil supplements can be high in PCBs,” said Chris Manthey, one of the plaintiffs. “That’s why many of them say their supplements have been ‘treated’ to remove or reduce PCBs. But since they don’t say how much PCB contamination is still left, even consumers who choose ‘treated’ supplements can’t know what PCB levels they're swallowing along with their daily omega-3.”
“Fish oil supplements are among the safest, most beneficial health products on the market. [This] announcement of a lawsuit against companies manufacturing or selling popular products is just that—a lawsuit looking for media attention, not a public safety concern for consumers,” countered Andrew Shao, PhD, senior vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN). “It is important to put this into context. PCBs are ubiquitous within the environment, which means that all fish—whether fish found in oceans and rivers or fish oil supplements—contain at least trace amounts of PCBs. In fact, conventional food forms of fish contain higher levels of PCBs than fish oil supplements in part because supplement fish oil products go through a refining process, which reduces PCBs and other contaminants. The FDA has established a tolerance level for PCBs in fish, which is 2.0 parts per million (ppm, also expressed as mg/kg) or 2,000 parts per billion; in comparison, the Prop. 65 daily limit for PCBs for a cancer warning is 90ng/day, which is significantly lower than what FDA deems safe.”
“These products are legal in 49 other states,” agreed Ullman. “There is no health issue here. As for consumer reaction, in California, interestingly, there would be little to no effect because these warnings are so pervasive that they’ve become meaningless. More likely they’d affect consumers outside California where they’re not used to seeing this.”
Dr. Ikhlas Khan, PhD, assistant director of the National Center for Natural Products Research and professor of pharmacognosy at the University of Mississippi was awarded the Herbal Insight award for furthering the knowledge and understanding of medicinal and aromatic plants. Khan’s efforts on behalf of herbal knowledge include his commitment to fostering the research of future generations of botanical scientists, enhancing knowledge of botanicals among regulators through his role as director of the FDA Center for Excellence in Botanicals at the National Center for Natural Products Research and contributing to the growing body of science on botanicals. Khan’s primary research interests include analytical fingerprinting for standardization of herbal products, and bio-analytical approaches to improvement of product quality and safety. He is the author or co-author over 300 original research articles, publications and reviews. He also serves as the director for Sino-US TCM Research Center and as the director of the Center for Research of Indian Systems of Medicine (CRISM).
The Herbal Industry Leader award, presented to a company with outstanding business practices, has been awarded to Gaia Herbs. Notable achievements include advancements in the understanding of echinacea through research funded by federal Small Business Innovative Research grants; recent introduction of the EarthBottle™ (an all-natural, plant-based, biopolymer composite resin technology for packaging dietary supplements and body care products); charitable donations of organic produce through its Community Supported Agriculture project; consistent support of naturopathic medical education, including the annual Medicines From the Earth Symposium now in its 18th year; successful development of its 250 acre commercial, educational and research farm in western North Carolina; and key support for an 800-acre public-private botanical sanctuary and medicinal plant research farm in Costa Rica. The 2010 AHPA Awards were presented during the association’s annual member meeting in Anaheim, CA March 11.