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Food and Drug Administration (FDA)

NPA advocates for foods, dietary supplements, personal care/health/beauty aids, and home care products. While the NPA is committed to advocating for the rights of manufacturers, suppliers, and retailers to have a marketplace in which to sell products, we are also committed to consumers having access to quality products that will maintain their health and well-being.

The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition regulates most natural products ranging from conventional foods to dietary supplements to cosmetics with regard to public health and enforcement.

The Center for Food Safety and Applied Nutrition, known as CFSAN, is one of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of the Food and Drug Administration (FDA). FDA is a public health and scientific regulatory, compliance, and enforcement agency responsible for the safety of the nation’s domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.

The Center has over 800 employees, who range from secretaries and other support staff to highly specialized professionals–such as chemists, microbiologists, toxicologists, food technologists, pathologists, molecular biologists, pharmacologists, nutritionists, epidemiologists, mathematicians, sanitarians, physicians and veterinarians.

The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. Most Center staff members work in the Center’s headquarters in College Park, Maryland.

Here’s what you need to know about the FDA, as well as NPA’s efforts to protect and support the industry’s right to do business in regards to the FDA:

  • DIETARY SUPPLEMENTS
    • New Dietary Ingredients (Identity and Safety)
  • FOOD ADDITIVES
    • Ingredient Identity and Safety
      • Food Ingredients and Dietary Ingredients (Food Safety Modernization Act)
      • Color Additives in Cosmetics (Color Additive Petitions)
      • Food Additive Petitions (for Food Additives in Conventional Foods and Dietary Supplements)
  • GRAS INGREDIENTS
    • Generally Recognized as Safe (GRAS) Notifications
  • Food Contact Substance Notifications (interaction of packaging with food)
  • COSMETICS AND COLORS
  • Quality in Manufacturing
    • Current Good Manufacturing Practices for Dietary Supplements (part 111 cGMPs)
    • Conventional Food cGMP (cGMPs used in Manufacturing, Packing, or Holding Human Food — Part 110)
    • Seafood HACCP
    • Low Acid Canned Foods
  • Claims (structure function v. disease claims) on products
    • dietary supplements
    • conventional foods
    • cosmetics
  • Labeling
    • dietary supplements
    • conventional foods
    • cosmetics
  • Serious Adverse Event Reports (SAERs) and Voluntary Adverse Events
  • Spiked Products (regulated as drugs)
  • Imports/Exports

 

Food Ingredients – Identity and Safety – subcategory

 

Food Additives and Dietary Ingredients — FDA Food Safety Modernization Act (FSMA)

FSMA was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

 

A full text of FSMA can be found at:

http://www.gpo.gov/fdsys/pkg/PLAW-111publ353/pdf/PLAW-111publ353.pdf.

 

FSMA addresses the following:

  • Improving the capacity to prevent food safety problems through
  • Inspections of records
  • Registration of food facilities
  • Hazard analysis and risk-based preventive controls (PCs)
  • Performance standards
  • Standards of produce safety
  • Protection against intentional adulteration
  • National agriculture and food defense
  • Sanitary transportation of food
  • Food allergy and anaphylaxis management
  • New Dietary Ingredients (NDI Guidance for Industry)
  • Post harvest processing of raw oysters
  • Port shopping
  • Alcohol-related facilities
    • Detecting and Responding to Food Safety Problems
  • Laboratory accreditation for analyses of foods
  • Enhancing tracking and tracing of food and recordkeeping
  • Surveillance
  • Mandatory recall authority
  • Administrative detection of food
  • Decontamination and disposal standards and plans
  • Enhancing food safety
  • Improving the reportable food registry (firms reporting adverse events for dietary supplements are exempt from reporting to the Reportable Food Registry)
    • Safety of Imported Food
  • Foreign Supplier Verification Program
  • Voluntary qualified importer program
  • Import certifications for food
  • Prior notice of imported food shipments
  • Inspection of foreign food facilities
  • Accreditation of third-party auditors

The U.S. Food and Drug Administration (FDA) regulates natural products ranging from food to dietary supplements to cosmetics in regards to consumer safety and health. Here are NPA’s current efforts to protect and support the industry’s right to do business in regards to the FDA:

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Conversely, the Federal Trade Commission (FTC) is another regulatory body for our industry. See NPA’s efforts regarding the FTC.