Manushvi Chadha, BPharm, RA Cert
Regulatory Associate, Dicentra
The FDA recognizes that the production of FDA-regulated products has gone international, with more globalization on the way. Not only wholly manufactured products, but raw materials are now being imported into the USA. This significantly blurs the line between “domestic” and “international” products, throwing up regulatory challenges. The coming years will show an upward trend in such globally produced products based on growing demand and easier access.
As part of the FDA’s solution to deal with this scenario, the FDA has released their new approach to monitor the standards of imported products in a document called “Pathway to Global Product Safety and Quality” (link: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OC/GlobalProductPathway/UCM259845.pdf)
The report talks about the FDA’s plans to globalize the field of regulatory affairs by partnering with regulatory bodies worldwide to improve the safety and quality of products and to make joint efforts in increasing the sharing of regulatory resources by developing international data system networks. They also want to focus on risk analysis and information technology and also aim to leverage use of third parties, industry and the public based on risk. The FDA has already been involved in collaboration with the regulatory authorities in the EU and Australia, and has been steadily increasing the number of foreign drug manufacturing inspections.
The Food Safety Modernization Act (FSMA) is another important step in this direction. There is a new anti-smuggling strategy in place to prevent foods from being smuggled into the country, authorities can now suspend registration of food facilities, and the FDA can also detain food products if they have reason to suspect adulteration or misbranding.
As part of these steps, a draft guidance has been recently released for new dietary ingredients. (link: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm)
The guidance intends to outline when a premarket safety notification is required for dietary supplements that contain NDIs and the procedure for the same. NDIs are ingredients not marketed in the USA before October 15, 1994. However, there is no list available for the ingredients that are not considered NDIs. NDIs are also required if a change in the manufacturing process alters the chemical composition or structure of an ingredient that was either marketed before Oct. 15, 1994, or has already been submitted as an NDI. Of note is the clarification made regarding synthetics and extracts. The guidance indicates that synthetic copies of a constituent or extracts of a herb / botanical are not to be considered as dietary supplements.
Dicentra is participating in the US discussion by offering a position statement to the Natural Product Association, expanding awareness of this issue through our webinars and utilizing our network with US trade associations to offer appropriate support on this matter.
For further information on regulatory and scientific issues please contact our experts at Dicentra.
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