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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 10
First page : ( 4744) Last page : ( 4748)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00864.8

Food Facility Registration US-FDA

Subaranjani R.*, Dr. Kamaraj Raju

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Kanchipuram, Tamil Nadu, India

*Corresponding Author E-mail: subaranjani6@gmail.com

Online published on 20 December, 2018.

Abstract

Nutraceutical is any food or any food part which provides health benefits. They are found in the way of Pills, capsules and powders. They act by preventing or treating diseases. A dietary supplement is a type of preparation administered by the oral route, which is meant for supplementing the diet, it consists of dietary ingredients and the product label must state that it is a dietary form of supplement. A functional food which is being used can be identical, or maybe, a conventional food, which can be either taken as a normal diet form. Nutraceutical are enriched with micro or macronutrients. In the USA, the FDA governs dietary supplements according to the Dietary Supplement Health and Education Act (DSHEA) 1994. This act includes a measure for safety and guidance on good manufacturing practice (GMP). Under DSHEA, manufacturers are responsible for marketing the very safe and properly labeled products. Information required for registration and optional information are mentioned below. The facility registration can be done by using paper, online and also by CD-ROM. The FSMA enacted on January 4, 2011, amended the Federal Food section 415, Drug, and Cosmetic Act (FD and C Act), in relevant part. Main purpose is to provide the facilities which are involved in the process of manufacturing, packaging, processing or holding. Safety portal can be used by dietary supplement manufacturers, researches and also by the drug manufacturers.

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Keywords

Nutraceutical, Dietary supplement, Facility Registration, FSMA, DSHEA, US-FDA, Safety portal.

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