Hyland�s Teething Tablets Recalled
Standard Homeopathic Company (Los Angeles, CA), in consultation with the US Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility.
The Hyland’s Teething Tablets UPC codes included in the recall are:
- Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
- Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
- Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
- Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
- Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
- Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109
Adverse events have been reported but the FDA has said that a conclusive link has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm, the company said.
After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers, it said in a statement. In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.
Consumers concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall or call (877) 496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).
“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, president and chief pharmacist of Standard Homeopathic Company. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”
Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets.
No other Standard Homeopathic Company products are affected by this recall. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at (800) FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
NPA Launches Retailer Toolkit
The Natural Products Association (NPA) recently announced a resource to help retailers stay within the legal limits of dietary supplement claims. The NPA Retailer’s Staff Education Toolkit can be used to educate retail staff about what should and should not be discussed with customers. The toolkit also contains customer-friendly materials for stores.
“The Natural Products Association continues to provide relevant and up-to-date information about the legal parameters of claims about dietary supplements,” said John Gay, NPA executive director and CEO. “Retailers need to be aware of what may be said to customers about dietary supplements and their use, or they may find themselves facing fines or other legal action. NPA is leading the way so that retailers stay within the law.”
The toolkit is currently available only to NPA members, though the association plans to provide a version of the toolkit for all retailers.
Retailer resources include:
- FDA handbook that explains government regulations and permitted information about dietary supplements, in addition to guidance on how to handle FDA inspections and what third-party information may be given to customers
- Brochure with a summarized version of the most important areas covered in the handbook
- Wallet card that staff can use for quick reference on the key points to remember when discussing dietary supplements
Customer resources include:
- Shelf talker that details the type of verbal and print information customers can expect to receive
- Flyer with a brief overview of federal regulations for dietary supplements and the information that can be offered in the store
- Poster that tells how staff may help them
For more information, visit www.npainfo.org
Organic Products Retailer News
Minneapolis Co-op Refunds $1M to Members
The Wedge Co-op, a Minneapolis natural food co-op with more than 14,500 members, will distribute $1 million in cash in a patronage refund to its members this year, the largest in the co-op’s history. It is also likely to be the largest-ever patronage refund provided by a single-store grocery co-op, it said in a statement.
Patronage refunds are a major benefit that The Wedge and other co-ops nationwide distribute to their members in profitable years. The Wedge, the annual sales of which have increased every year since its 1974 founding, has given $6 million in cash back to its members since 2000.
Typically, cooperatives determine individual members’ refunds from their share of overall purchases at the co-op during the previous year. The average check size this year for individual Wedge Co-op members is $58, with actual checks ranging from $2 to $1,731.
During this profitable year, The Wedge also gave $458,000 in cash and in-kind donations to community charities. In the face of the recession, the co-op avoided layoffs, continued to offer raises and continued to provide health insurance to its full-time staff. The co-op maintains a strong commitment to local producers, organic standards and sustainability, demonstrated by the high volume of organic and local products it sells. Last fiscal year, local products accounted for 33 percent of overall sales. Organic products were 40 percent of sales.
“Individuals join our co-op in part to support local farmers and food producers,” said Lindy Bannister, Wedge Co-op’s general manager. “But that support also is reciprocated in the form of patronage refunds in years of profit. That’s one beauty of co-ops: the profits stay here in our town and state, and aren’t sent away to a corporate headquarters in another market or nation.”
For more information, visit www.wedge.coop
OTA Presents Organic Leadership Awards
Theresa Marquez of Organic Valley (LaFarge, WI) and Bob Quinn of Kamut® International (Big Sandy, MT) received Organic Trade Association’s (OTA’s) prestigious Organic Leadership Awards for 2010 in ceremonies held October 15, in Boston, MA.
“Theresa Marquez and Bob Quinn have shown outstanding initiative and devotion to organic, and their contributions clearly demonstrate how organic enterprises and agriculture can thrive and make a difference to consumers, farmers and to our planet,” said OTA Executive Director and CEO Christine Bushway.
Marquez, chief marketing executive of Organic Valley, received the OTA Organic Leadership Award in the “Growing the Organic Industry” category, while Quinn, president of Kamut International, received the award in the “Growing Organic Agriculture” category. The 2010 Organic Leadership Award recipients were honored at the OTA Annual Dinner and Dance during OTA Member Days activities at Natural Products Expo East in Boston. Each recipient received a hand-blown glass “planet” by artist Josh Simpson. In special tributes to Quinn and Marquez, video messages from Senator Jon Tester of Montana and Deputy Secretary of Agriculture Kathleen Merrigan were played during the ceremonies.
Involved in organic agriculture since the 1970s, Quinn has devoted his career to building Kamut, an organic crop, which has become an organic stand-alone grain product as well as an ingredient in other organic breads and grain products. He has promoted organic agriculture throughout his home state of Montana, encouraging other farmers to go organic, and has worked with his local land grant university to develop research helpful to organic agriculture. He has also introduced organic agricultural products and encouraged organic production in other countries. Quinn’s company, Kamut International, has been a member of OTA since 1998, and Quinn has contributed to OTA’s public policy efforts.
Involved with the organic movement and emerging organic industry for the past 35 years, Marquez served on the Board of Directors of the Organic Foods Production Association of North America, the original organization that subsequently became OTA. She again served on OTA’s Board of Directors from 2001-09. She was also the founding president of The Organic Center. Marquez joined Organic Valley’s marketing efforts in 1995 when the business was selling $5 million. In 2009, it had grown to $523 million. Today, Organic Valley is America’s largest organic farming cooperative, representing 1,631 farmers in 33 states and four Canadian provinces, and remains focused on its mission of saving family farms.
For more information, visit www.ota.com
Nutrition Industry Executive News
FDA Issues Regulatory Science Report
The US Food and Drug Administration (FDA) recently unveiled a report outlining the agency’s plans to advance regulatory science through its Regulatory Science Initiative.
Regulatory science is the science of developing new tools, standards and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products, the Administration said.
The report provides examples of current FDA activities in regulatory science and also considers how advancements in the field can help deliver better, safer, more innovative products to Americans in seven different public health areas.
Copies of the report were released at the National Press Club in Washington, DC, when FDA Commissioner Margaret A. Hamburg, MD spoke to a club luncheon.
Her address was broadcasted live by C-SPAN October 6.
The report, Advancing Regulatory Science for Public Health, will also be posted online at www.fda.gov
WILD, Sterling Technology Enter Partnership
WILD Flavors, Inc. (WILD, Erlanger, KY) recently announced a new partnership with Sterling Technology (Brookings, SD). This partnership makes WILD the exclusive provider of both Immunel™ and Tegricel™, and these bioactive milk peptide products will now be included in WILD’s Health Ingredient Technology & Solutions® (H.I.T.S.®) lineup.
“We’re very pleased to be able to announce our partnership with Sterling Technology. A company the caliber of Sterling, with its quality products and research, will enable WILD to continue offering the most cutting-edge ingredients and solutions,” said WILD Chief Operating Officer Erik Donhowe.
This new partnership will combine Sterling’s scientific research expertise in bioactive milk peptides with WILD’s product development and flavor expertise, WILD said. With Sterling Technology’s years of clinical studies and GRAS status, WILD will be able to utilize its skills to incorporate Immunel and Tegricel into efficacious, great-tasting food and beverage products.
For more information about WILD Flavors, call (888) WILD-FLAVORS or visit www.wildflavors.com
. To learn more about Sterling Technology, call (800) 522-3699 or visit www.sterlingtechnology.com