August 4, 2011
The U.S. Food and Drug Administration (FDA) has reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease and invites comment on these additional data.
One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20ppm. The threshold of less than 20ppm also is similar to “gluten-free” labeling standards used by many other countries.
People who have celiac disease cannot tolerate gluten, a protein in wheat, rye, and barley. Celiac disease damages the small intestine and interferes with absorption of nutrients from food. About one percent of the U.S. population is estimated to have the disease.
“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”
The proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008, which requires that foods labeled as “gluten-free” not contain more than 20ppm gluten. This standard has been adopted in regulations by the 27 countries composing the Commission of European Communities.
The FDA encourages members of the food industry, state and local governments, consumers and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404 at www.regulations.gov. The docket officially opened for comments on August 3, 2011 and will remain open for 60 days after.
For more information, visit www.fda.gov.
A growing body of evidence suggests that antioxidants may have significant value in addressing infertility issues in both women and men, including erectile dysfunction (ED), and researchers say that large, specific clinical studies are merited to determine how much they could help.
A new analysis, published online in the journal Pharmacological Research, noted that previous studies on the potential for antioxidants to help address this serious and growing problem have been inconclusive, but that other data indicates nutritional therapies may have significant potential.
Researchers also observed that infertility problems are often an early indicator of other degenerative disease issues such as atherosclerosis, high blood pressure and congestive heart failure. The same approaches that may help treat infertility could also be of value to head off those problems.
The findings were made by Tory Hagen, at the Linus Pauling Institute at Oregon State University, and Francesco Visioli, lead author of the study at the Madrid Institute for Advanced Studies in Spain. “If oxidative stress is an underlying factor causing infertility, which we think the evidence points to, we should be able to do something about it,” said Hagen, Jamieson Chair of Healthspan Research in the Linus Pauling Institute. “This might help prevent other critical health problems as well, at an early stage when nutritional therapies often work best.”
The results from early research have been equivocal, Hagen said, but that may be because they were too small or did not focus on antioxidants. Laboratory and in-vitro studies have been very promising, especially with some newer antioxidants such as lipoic acid that have received much less attention.
The researchers from Oregon and Spain point, in particular, to inadequate production of nitric oxide (NO), an agent that relaxes and dilates blood vessels. This is often caused, in turn, by free radicals that destroy NO and reduce its function. Antioxidants can help control free radicals. Some existing medical treatments for ED work, in part, by increasing NO production.
Aging, which is often associated with ED problems, is also a time when NO synthesis begins to falter. And infertility problems in general are increasing, scientists say, as more people delay having children until older ages.
If new approaches were developed successfully, the researchers said, they might help treat ED in men, egg implantation and endometriosis in women, and reduce the often serious and sometimes fatal condition of pre-eclampsia in pregnancy. The quality and health of semen and eggs might be improved.
As many as 50 percent of conceptions fail and about 20 percent of clinical pregnancies end in miscarriage, the researchers noted in their report. Both male and female reproductive dysfunction is believed to contribute to this high level of reproductive failure, they said, but few real causes have been identified.
Some commonly used antioxidants, such as vitamins C and E, could help, Hagen said. But others, such as lipoic acid, are a little more cutting-edge and set up a biological chain reaction that has a more sustained impact on vasomotor function and health.
Polyphenols, the phytochemicals that often give vegetables their intense color and are also found in chocolate and tea, are also of considerable interest. But many claims are being made and products marketed, the researchers said, before the appropriate science is completed–actions that have actually delayed doing the proper studies.
For more information, visit lpi.oregonstate.edu.
The Organic Trade Association (OTA) has selected Michael Funk of United Natural Foods Inc. (UNFI) and Mark Lipson of the U.S. Department of Agriculture (USDA) to receive its prestigious Organic Leadership Awards for 2011.
“Both Michael Funk and Mark Lipson have had a long commitment to the organic movement,” said Christine Bushway, OTA’s executive director and CEO. “Michael has been instrumental in the growth and advancement of the natural and organic industry for over 30 years, while Mark has demonstrated personal commitment, leadership and vision with regard to advancing organic farming since the early 1980s.”
Funk, UNFI’s chairman of the board, will receive the OTA Organic Leadership Award in the “Growing Organic Industry” category, while Lipson, organic and sustainable agriculture policy advisor in USDA’s office of the secretary and undersecretary for marketing and regulatory programs, will receive the award in the “Growing Organic Agriculture” category. The 2011 Organic Leadership Award recipients will be honored at the September 21 OTA Awards Gala during OTA Member Day activities at Natural Products Expo East in Baltimore, MD. Recipients will receive a hand-blown glass “planet’ by artist Josh Simpson.
According to Funk’s nomination letter submitted by a UNFI colleague, “Michael is truly committed to providing quality natural and organic products to consumers and is a tireless supporter of our industry. A long-time environmental advocate, his care and stewardship for the environment are evident in the way he lives his own life as well as passion about proactively reducing his carbon footprint. After many years of growing a successful business, he easily could have retired and enjoyed his good fortune, but instead, chooses every day to actively support, teach and inspire others.”
Lipson joined USDA in June 2010 as organic and sustainable agriculture policy advisor. His responsibilities include cross-agency coordination of organic farming policy issues and assisting with the “Know Your Farmer, Know Your Food” initiative. In his current position, “Mark impacts organic policy on a daily basis. Always with the organic farmers’ best interests in mind, Mark continues to impact the growing organic industry that he helped to create,” according to his nomination letter submitted by Maureen Wilmot, executive director at Organic Farm Research Foundation.
For more information, visit www.ota.com.
With Mrs. Gooch’s Natural Foods Markets, her groundbreaking seven-store natural foods chain in Los Angeles, Sandy Gooch in the 1970s, ‘80s and ‘90s single-handedly set a higher standard for product quality, store offerings and customer service. Her full-service natural and organic food stores drew throngs of loyal customers, received numerous national awards and influenced a new generation of natural products retailers, including Whole Foods Market, Alfalfa’s Market and many others. The term “Is it Goochable?” challenged many natural products manufacturers to meet Gooch’s product standards, which were among the strictest in the industry.
Gooch will be in Boulder, CO along with her husband and business partner Harry Lederman, and fellow natural products retail pioneer Cheryl Hughes, to speak with an audience of business and community leaders in the Boulder-Denver region on Tuesday, August 23 from 5:30–7:30 p.m., as part of “An Evening at the Epicenter.” The interactive discussion will focus on practical business advice for entrepreneurs, along with trends and opportunities in the $300 billion Lifestyles of Health and Sustainability (LOHAS) market for natural, organic and sustainable products.
An Evening at the Epicenter is produced and presented by Boulder-based businesses Best Organics Inc. and Compass Natural LLC. The interactive discussion featuring Gooch, Lederman and Hughes will be preceded by a welcoming reception featuring natural and organic beverages and appetizers. The event will be held at the offices of the Sterling Rice Group in downtown Boulder.
For ticket information, visit www.eventbrite.com/event/1955586211.
The American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA) jointly requested an extension from FDA for filing comments on the recently released NDI draft guidance.
In the letter, sent on August 3, 2011, the associations said that they appreciate the opportunity to provide comments on the Agency’s draft guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” released on July 5, 2011 (76 Federal Register 39111-39112). The associations also applauded FDA for releasing the document and welcomed the opportunity to provide comments with respect to the draft guidance.
“The Agency’s draft guidance for industry on new dietary ingredient (NDI) notifications is thorough and complex, thus requiring an in-depth review by stakeholders,” commented the associations. “In the July 5th Federal Register notice, FDA allowed for a 90-day public comment period. However, members of our respective organizations believe additional time is needed to adequately prepare meaningful feedback for the agency’s consideration. Therefore, on behalf of AHPA, CHPA, CRN, NPA and UNPA members, we are requesting that FDA extend the submission deadline by an additional 45 days (i.e., November 17, 2011).”
The Natural Products Association (NPA) and Grifcon Enterprises (Chicago, IL) have announced a new partnership to provide ThinkRisk Vitamin and Supplement Program liability insurance for California Proposition 65 claims to NPA members. Through Grifcon Enterprises, NPA member companies can receive coverage for false advertising, labeling, and media and intellectual property claims, as well as privacy and data security claims. Program participants also will have access to risk management material to help them mitigate their exposure to these claims.
California’s Proposition 65, which was passed into law by voter referendum in 1986, requires manufacturers selling products in California to list on the label any detectable amount of more than 800 chemicals believed to cause cancer, birth defects or other reproductive harm. The new insurance program provides coverage for NPA members against certain Proposition 65 claims.
Benefits of the program include:
“NPA members now have access to an affordable insurance program that can help protect them against Proposition 65 claims in California,” said John Gay, NPA executive director and CEO. “We’ve been seeing rising litigation costs for companies responding to Proposition 65 claims. This new insurance program helps provide protection against those claims.”