12.28.15
The U.S. Food and Drug Administration will create an Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements. The FDA is also in the process of identifying permanent leadership for ODSP. In the meantime, Bob Durkin continues to serve as acting office director.
In the 20 years since the establishment of the dietary supplement program, the industry has grown from about $6 billion to more than $35 billion in annual sales. Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry.
In the last several years, FDA has taken numerous actions on dietary supplements to protect public health. The Office of Dietary Supplements Programs will continue to utilize its current authorities and available resources to monitor the safety of dietary supplement products by continuing to:
• Take action to remove from the market supplement products that are dangerous to consumers;
• Work with FDA’s Center for Drug Evaluation and Research to help remove from the market products falsely labeled as dietary supplements that contain potentially harmful pharmaceutical agents;
• Enforce the dietary supplement good manufacturing practices (GMP) regulation, giving priority to cases in which GMP violations potentially compromise product safety; fail to ensure product identity, potentially jeopardizing consumer safety; and result in consumer deception, when, for example, manufacturers do not verify the identity of their raw materials.
• Take action against claims in cases involving serious risk of harm to the consumer (such as egregious claims of benefit in treating serious diseases) or widespread economic fraud.
As a result of the transition, ODSP’s former parent office will now be known as the Office of Nutrition and Food Labeling, under the leadership of Doug Balentine, PhD, who joined FDA on Dec. 14. Dr. Balentine has a PhD in food science and nutrition from Rutgers University. As the head of the Office of Nutrition and Food Labeling, Dr. Balentine will oversee the development of policy and regulations for nutrition labeling and food standards, infant formula and medical foods. Dr. Balentine brings a wealth of knowledge and expertise to this position.
Associations Welcome Actions
The five trade associations representing the dietary supplement industry welcomed the elevation of the DDSP to an Office status within FDA’s Center for Food Safety and Applied Nutrition (CFSAN). 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) also congratulated the Department of Health and Human Services (HHS), FDA, and Congress for supporting this reorganization, which will enhance the effectiveness of dietary supplement regulation.
There has been considerable industry growth since DDSP was established in 1994, and with this growth, new regulatory challenges within the industry have presented themselves. The five associations have been consistent and longstanding in their joining together to urge FDA to take stronger enforcement action against companies illegally manufacturing and selling adulterated products.
In a letter of support to Congress sent earlier this month, the associations expressed belief that the elevation of DDSP to an "Office" could help "increase FDA's abilities to take more aggressive enforcement action." Additionally, the groups anticipate that the elevation could "raise the visibility and attention for dietary supplement safety and compliance measures at FDA," as well as "better utilize CFSAN's enforcement resources."
Overall, the industry views the elevation of DDSP not only as a demonstration of the government's commitment to eliminating the illegal activity and leveling the playing field for the responsible companies already following the law, but also as an important step for increasing consumer safety by cracking down on rogue manufacturers who sell illegal products. As stated in an earlier joint letter to HHS, "Such a move would aid in accomplishing FDA's current and long-range goals related to dietary supplements."
“This is a long overdue step towards elevating the dietary supplement division within FDA so that it can exercise all the authorities it has to regulate this important industry,” said Dan Fabricant, PhD, executive director and CEO of NPA. “America’s dietary supplement supply is the safest in the world and this will give consumers additional confidence that the natural products they prefer meet their expectations. We strongly support this decision and will continue to work with FDA and other regulatory officials to deliver quality products for the millions of people in the U.S. and around the world.”
In the 20 years since the establishment of the dietary supplement program, the industry has grown from about $6 billion to more than $35 billion in annual sales. Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry.
In the last several years, FDA has taken numerous actions on dietary supplements to protect public health. The Office of Dietary Supplements Programs will continue to utilize its current authorities and available resources to monitor the safety of dietary supplement products by continuing to:
• Take action to remove from the market supplement products that are dangerous to consumers;
• Work with FDA’s Center for Drug Evaluation and Research to help remove from the market products falsely labeled as dietary supplements that contain potentially harmful pharmaceutical agents;
• Enforce the dietary supplement good manufacturing practices (GMP) regulation, giving priority to cases in which GMP violations potentially compromise product safety; fail to ensure product identity, potentially jeopardizing consumer safety; and result in consumer deception, when, for example, manufacturers do not verify the identity of their raw materials.
• Take action against claims in cases involving serious risk of harm to the consumer (such as egregious claims of benefit in treating serious diseases) or widespread economic fraud.
As a result of the transition, ODSP’s former parent office will now be known as the Office of Nutrition and Food Labeling, under the leadership of Doug Balentine, PhD, who joined FDA on Dec. 14. Dr. Balentine has a PhD in food science and nutrition from Rutgers University. As the head of the Office of Nutrition and Food Labeling, Dr. Balentine will oversee the development of policy and regulations for nutrition labeling and food standards, infant formula and medical foods. Dr. Balentine brings a wealth of knowledge and expertise to this position.
Associations Welcome Actions
The five trade associations representing the dietary supplement industry welcomed the elevation of the DDSP to an Office status within FDA’s Center for Food Safety and Applied Nutrition (CFSAN). 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) also congratulated the Department of Health and Human Services (HHS), FDA, and Congress for supporting this reorganization, which will enhance the effectiveness of dietary supplement regulation.
There has been considerable industry growth since DDSP was established in 1994, and with this growth, new regulatory challenges within the industry have presented themselves. The five associations have been consistent and longstanding in their joining together to urge FDA to take stronger enforcement action against companies illegally manufacturing and selling adulterated products.
In a letter of support to Congress sent earlier this month, the associations expressed belief that the elevation of DDSP to an "Office" could help "increase FDA's abilities to take more aggressive enforcement action." Additionally, the groups anticipate that the elevation could "raise the visibility and attention for dietary supplement safety and compliance measures at FDA," as well as "better utilize CFSAN's enforcement resources."
Overall, the industry views the elevation of DDSP not only as a demonstration of the government's commitment to eliminating the illegal activity and leveling the playing field for the responsible companies already following the law, but also as an important step for increasing consumer safety by cracking down on rogue manufacturers who sell illegal products. As stated in an earlier joint letter to HHS, "Such a move would aid in accomplishing FDA's current and long-range goals related to dietary supplements."
“This is a long overdue step towards elevating the dietary supplement division within FDA so that it can exercise all the authorities it has to regulate this important industry,” said Dan Fabricant, PhD, executive director and CEO of NPA. “America’s dietary supplement supply is the safest in the world and this will give consumers additional confidence that the natural products they prefer meet their expectations. We strongly support this decision and will continue to work with FDA and other regulatory officials to deliver quality products for the millions of people in the U.S. and around the world.”
