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Food, Additives, Dietary Supplements...

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FDA Application and GMP Consulting

Food, Additives, Dietary Supplements...

Food and Dietary Supplement

Definition of Food

  • Articles used for food or drink for man or other animals
  • Chewing gum
  • Articles used for components of any such article

Dietary Supplement

Product intended to supplement the diet which is taken by mouth and contains dietary ingredients including vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, metabolites, concentrates, or extracts. A component in a dietary supplement that was not sold in the U.S. before October 15, 1994 is considered a new dietary ingredient (NDI) subject to pre-market approval by the U.S. FDA.

Food Labeling

  • Ingredients & nutrition facts
  • Claims (health, nutrient content, and structure/function)
  • Declaration: allergens, biotechnology, irradiation,botanicals freshness, etc.

Export into U.S.

  • Registration of food facilities
  • Detection of microbials, pesticides, metals, chemical contaminants, and natural toxins
  • Pre-market clearance for new dietary ingredients (NDIs)
  • Special requirements for: acidified and low low acid canned foods, juices, seafood, dairy products, genetically modified foods, infant formula, etc.
  • Prior notice of food shipments

Services

  • Conducting GMP auditing for facilities according to U.S. FDA抯 requirement
  • Acting as a U.S. agent for registration of food facilities
  • Assisting in determination of food wholesomeness
  • Preparing food and dietary supplement labels including claims
  • Submitting claims for necessary pre-market approval
  • Preparing and submitting pre-market NDI notification to FDA
  • Applying USDA permit for animal- and plant-derived food
  • Meeting and corresponding to the U.S. FDA
  • Identifying clients in need of foods and dietary supplements

BBC Training

Released courses on FDA application training and GMP training for dietary supplement and food:

Food/Color Additives and Packaging

Food and Color Additives

All new food and color additives, including antimicrobial food additives, require pre-market approval by the U.S. FDA through food additive petition (FAP) or color additive petition (CAP) unless its use is generally recognized as safe (GRAS).

Materials Needed for Review

  1. Environmental impact assessment
  2. Chemistry and exposure assessment
  3. Toxicology data from GLP laboratories
  4. Clinical data (not required)

Genetically Modified Foods

Proposed rule of the U.S. FDA require that developers submit a scientific and regulatory assessment of genetically modified food through biotechnology notification file (BNF) 120 days before marketing.

GRAS Program

A GRAS status of a substance may be established by history of common use or by scientific procedures through GRAS notification (GRN) to the U.S. FDA.

Food Contact Substances

The U.S. FDA requires reviewing a food contact notification (FCN) for any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.

Services

  • Conducting GMP auditing and GLP auditing for facilities
  • Assessing hazard analysis and critical point (HACCP)
  • Preparing FAPs or CAPs for food or color additives
  • Preparing BNFs for genetically modified foods
  • Preparing GRNs for GRAS substances
  • Preparing FCNs for food contact substances
  • Assessing exposure
  • Assessing environmental impact
  • Submitting petitions and notifications to the U.S. FDA