Natural Products Insider

APR 2012

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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In the News Regulatory Update: Warnings, Funding and Recognition FDA sent a warning letter advising Schwabe North America Inc. that its Umcka® line of immune products is mislabeled and features drug claims. The agency said these products combine homeopathic ingredients with non-homeopathic ingredients, taking the products out of the homeopathic drug classification. Fur ther, FDA said a number of products in this line were associated with drug claims on the naturesway.com and umcka. com websites. FDA also said the labeling and website claims for these products make them unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 331 and 355). Even though a number of the pages on the websites contained a disclaimer stating the products are not intended to diagnose, treat, cure or prevent any disease, FDA said the Umcka products are drugs because they claim to mitigate or treat the common cold, flu, bronchitis, sinusitis and rhinitis. FDA said the disclaimer did not negate the other claims on the website. Mushroom Wisdom Inc. received a warning letter from FDA, which said marketing material collected at the company's booth at the Natural Products Expo East trade show in Baltimore and on the company's website brand some of its products as drugs, according to the Federal Food, Drug and Cosmetic Act. In response to the warning letter, Mushroom Wisdom said it is working with FDA to respond to the concerns the agency raised. This is the second recent warning letter driven by trade show materials, following FDA's letter to Almased for a claims made in a weight-loss brochure the agency picked up at Expo East. FDA is asking Congress for approximately $19.5 million for dietary supplement activities in fiscal year (FY) 2013, which is roughly $600,000 more than FY 2012. The $19.5 million covers all dietary supplement activities across FDA, including the Center for Food Safety and Applied Nutrition (CFSAN) Division of Dietary Supplement Programs, as well as regulatory and technical review, policy and guidance development, research, education and outreach, compliance and inspection activities, and associated administrative support activities, including infrastructure costs. Industry wondered if this increase would be enough for FDA to regulate supplements effectively. According to Mike Greene, vice president of government relations for the Council for Responsible Nutrition (CRN), FDA was denied a budget increase by the White House because the agency received additional money last year. Instead of getting money from the budget, FDA said industry user fees would fund 98-percent of the proposed budget increase. Greene said user fees, in general, are quid pro quo for industry and FDA, but it's difficult to tell how much industry interaction will come with the new FDA-recommended user fees. "If there is a facility registration fee, is it just a tax on facilities, or does industry get something in return?" he asked. Cara Welch, Ph.D., vice president of scientific and regulatory affairs for the Natural Products Association (NPA), said NPA would like to know where and to what extent the user fees would cover the regulation of supplements and ingredients. "FDA has to come up with unconventional or creative ways to get more money," she said. "The entire industry has advocated for additional resources 6 INSIDER ¥ APRIL 2012 for the FDA; more resources means better regulation. However, if it is charging companies exorbitant fees to cover this, that and the other thing, that's not appropriate either." Citizens for Health (CFH) delivered a petition to Congress with more than 12,000 signatures supporting the withdrawal of FDA's new dietary ingredient (NDI) Draft Guidance, which it accused of being over-regulation. In hand-delivering the signatures to key legislators, CFH reached Rep. Ron Paul (R-Texas), who sent out a letter to his entire Congressional District outlining the dangers of the NDI Draft Guidance. As of the end of February, CFH has gotten more than 25,000 signatures and planned to deliver the new signatures to Congress. The EU Agriculture and Rural Development office and USDA signed a pact to work together to promote strong organic programs, protect organic standards, enhance cooperation and facilitate trade in organic products. The goal is to expand market access for organic producers and companies by reducing duplicative requirements and certification costs on both sides of the ocean while continuing to protect organic integrity. Starting June 1 this year, the pact will open free- flowing trade of certified organic products that meet the terms of the new arrangement. The agreement also stipulates the EU will recognize the USDA National Organic Program (NOP) as equivalent to the EU Organic Program, allowing USDA certified products to be marketed as organic in EU nations; the United States will, in turn, allow products certified through the EU program as organic in the United States. Among the requirements for accessing each others markets, products entering the United States must not have been created from animals administered antibiotics; and products entering the European Union must not be made from apples or pears subject to antibiotic use to control fire blight. To facilitate trade, the EU and United States have agreed to work together to promote electronic certification of import transaction certificates. The arrangement is limited to organic products of U.S. or EU origin produced, processed or packaged within these jurisdictions. Additionally, both programs have agreed to exchange information on animal welfare issues, and on methods to avoid contamination of organic products from genetically modified organisms (GMOs). In addition, general country labeling requirements must still be met. Rep. Frank Pallone Jr. (D-NJ) introduced a resolut ion in the House of Representatives to honor the 30th anniversary of the American Herbal Products Association (AHPA). When introducing the resolution to the House, Pallone said AHPA has now grown into a diverse trade association, representing nearly 300 companies in the herbal products industry and their affiliated businesses. He also told lawmakers AHPA has distinguished itself in the herbal and dietary supplement trades for the quality of its work and advocacy before lawmakers and regulators, citing the group's role in the Dietary Supplement Health and Education Act of 1994 (DSHEA) and adverse event report (AER) legislation. "AHPA and its members should be commended for their ongoing commitment to supporting the responsible commerce of herbs and herbal products in the United States," Pallone said. IN THE NEWS

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