From Nutraceuticals World
The threat of an EU-wide ban on the use of article 13.1 claims on the European Commission’s negative register is not expected before next summer, according to international food policy consultancy EAS. Stefanie Geiser, EAS regulatory affairs manager, said as the European Commission has indicated it intends to present its proposal for an article 13.1 “Union list” of claims to the Standing Committee for discussion and potential adoption only by the end of 2011, it was unlikely that any ban on rejected claims would come into force before spring or summer 2012.
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Strategy. Communications. Trade Relations.
Friday, July 1, 2011
Thursday, June 30, 2011
NOW International Earns IL Export Award
From Natural Products INSIDER
Illinois Governor Pat Quinn presented NOW International with the Governor’s Export Award for Continuing Excellence in Exporting in the large company (more than 500 employees) category. NOW Foods president Al Powers said the award recognizes NOW’s teamwork and its mission to help people live healthier lives with natural products.
The award recognizes businesses that exemplify significant contributions to Illinois’ economic development in the fields of export and manufacturing, service and agribusiness. This was the second time the State of Illinois honored NOW International’s track record of growing exports; the company received a similar award for 2008. The company has also been recognized twice with the U.S. President’s “E" Award for Achievement in Export.
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Illinois Governor Pat Quinn presented NOW International with the Governor’s Export Award for Continuing Excellence in Exporting in the large company (more than 500 employees) category. NOW Foods president Al Powers said the award recognizes NOW’s teamwork and its mission to help people live healthier lives with natural products.
The award recognizes businesses that exemplify significant contributions to Illinois’ economic development in the fields of export and manufacturing, service and agribusiness. This was the second time the State of Illinois honored NOW International’s track record of growing exports; the company received a similar award for 2008. The company has also been recognized twice with the U.S. President’s “E" Award for Achievement in Export.
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Wednesday, June 29, 2011
New Durbin Bill Would Change DSHEA
From Natural Products INSIDER
A new bill from longtime DSHEA critic Sen. Dick Durbin (D-Ill.) would change the way supplements are regulated in very significant ways and add a lot of new burdens and costs to the industry. All supplement companies would be required to register every product with FDA, including ingredient lists and a copy of the label. There would also be required warning labels on certain ingredients as determined by FDA and the Institute of Medicine (IOM). Also, all products with "proprietary blends" would have to disclose the amount of each specific ingredient in the blend (so basically, no more proprietary blends). There is more, and it is not good. Needless to say, this is a bad bill for industry and consumers.
A new bill from longtime DSHEA critic Sen. Dick Durbin (D-Ill.) would change the way supplements are regulated in very significant ways and add a lot of new burdens and costs to the industry. All supplement companies would be required to register every product with FDA, including ingredient lists and a copy of the label. There would also be required warning labels on certain ingredients as determined by FDA and the Institute of Medicine (IOM). Also, all products with "proprietary blends" would have to disclose the amount of each specific ingredient in the blend (so basically, no more proprietary blends). There is more, and it is not good. Needless to say, this is a bad bill for industry and consumers.
Tuesday, June 28, 2011
New Durbin Bill Goes After Supplements
From Natural Products INSIDER
Sen. Dick Durbin (D-Ill.) is again going after what he perceives to be weakly regulated dietary supplements by introducing a new bill this week that would require all supplements to be registered with FDA along with their labels and ingredients, require new cautions on labels, and require FDA to define what is a conventional food and what is a dietary supplement. The bill is called the Dietary Supplement Labeling Act.
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Sen. Dick Durbin (D-Ill.) is again going after what he perceives to be weakly regulated dietary supplements by introducing a new bill this week that would require all supplements to be registered with FDA along with their labels and ingredients, require new cautions on labels, and require FDA to define what is a conventional food and what is a dietary supplement. The bill is called the Dietary Supplement Labeling Act.
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Monday, June 20, 2011
FDA’s New Take on Imports
From Natural Products INSIDER
FDA is stepping up enforcement on imported foods, supplements and ingredients with a new strategy designed to meet the regulatory challenges posed by the increased number of products imported to the United States. A report released by FDA, titled "Pathway to Global Product Safety and Quality," calls for coalitions of and increased data sharing among international regulators.
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FDA is stepping up enforcement on imported foods, supplements and ingredients with a new strategy designed to meet the regulatory challenges posed by the increased number of products imported to the United States. A report released by FDA, titled "Pathway to Global Product Safety and Quality," calls for coalitions of and increased data sharing among international regulators.
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Monday, June 13, 2011
Dietary Supplement Industry and the Park Doctrine
From Natural Products INSIDER
By Nadia A. Karim
The Park Doctrine, as decided by the U.S. Supreme Court in United States v. Park, could be a potential threat to the dietary supplement industry. Under Park, companies can be criminally sanctioned for non-compliance with cGMPs (current good manufacturing practices).
Firms already struggling with qualitative and quantitative testing (e.g., pre- and post- production), quality control (QC), validation and documentation stand to face potential criminal consequences irrespective of whether there was intent to disregard cGMP.
If a dietary supplement firm is struggling with compliance related to the necessary testing requirements, it naturally follows that the firm likely will not be able to provide proof that a product is safe for human consumption as required by the new rules.
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By Nadia A. Karim
The Park Doctrine, as decided by the U.S. Supreme Court in United States v. Park, could be a potential threat to the dietary supplement industry. Under Park, companies can be criminally sanctioned for non-compliance with cGMPs (current good manufacturing practices).
Firms already struggling with qualitative and quantitative testing (e.g., pre- and post- production), quality control (QC), validation and documentation stand to face potential criminal consequences irrespective of whether there was intent to disregard cGMP.
If a dietary supplement firm is struggling with compliance related to the necessary testing requirements, it naturally follows that the firm likely will not be able to provide proof that a product is safe for human consumption as required by the new rules.
Read More
Wednesday, June 1, 2011
SIDI Working Group Comments on FSMA
From Nutraceuticals World
The Standardized Information on Dietary Ingredients (SIDI) Working Group, composed of dietary supplement firms and industry trade associations, recently submitted comments to FDA regarding the Food Safety Modernization Act (FSMA): “Title III—A New Paradigm for Importers.” SIDI supports establishing a strong program for qualifying raw material suppliers, testing incoming ingredients and verifying the contents of finished products in order to reduce the risks of contamination, adulteration and other supply chain failures.
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The Standardized Information on Dietary Ingredients (SIDI) Working Group, composed of dietary supplement firms and industry trade associations, recently submitted comments to FDA regarding the Food Safety Modernization Act (FSMA): “Title III—A New Paradigm for Importers.” SIDI supports establishing a strong program for qualifying raw material suppliers, testing incoming ingredients and verifying the contents of finished products in order to reduce the risks of contamination, adulteration and other supply chain failures.
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