FDA regulations affecting Food & Beverage

The FDA regulates foods and beverages marketed within the US. These include dietary supplements, processed foods for human consumption, alcoholic and bottled water, produce including fruits and vegetable, fish and seafood, dairy products and a multitude of other foods. The regulatory requirements pertain to –

  • the contents or ingredients:
    • dietary ingredients in dietary supplements,
    • food additives such as binders, excipients, fillers,
    • color additives,
  • the labeling,
  • the packaging and food contact substance,
  • the advertising,
  • the facilities in which they are produced or processed.

Every facility that manufactures, processes, packs or holds human food for importation or sale in the US must have an active registration in the US[1], which is to be renewed every 2 years on even years (eg 2016, 2018). A foreign[2] facility is required to appoint a US agent at the time of registration who will serve as an intermediary between the FDA and the facility. The FDA is authorized to inspect any establishment and to suspend the registration of any facility that does not comply with FDA regulations. The FDA is also authorized to mandate the removal of any product on the market.

Food additives[3] require premarket approval unless they are generally recognized as safe (GRAS)[4] substances. Foods and beverages containing additives that are not FDA approved or not GRAS are considered adulterated and cannot be legally marketed or distributed in the US. Similarly, this applies to color additives[5].

As for food labeling, generally the FDA requires a statement of identity, net quantity statement, address and name of the manufacturer, packer or distributor of the product, list of ingredients, nutrition facts and food allergen statement. In particular, the format of the nutritional table was updated in May 2016. These are effective July 26, 2018 (a further year for manufacturers selling less than 10 million units/year). An example of the new format, compared to the old is shown below.

[1] Food Safety Modernization Act.

[2] In addition to registration and appointing a US agent, other changes that will affect a foreign supplier include the Produce Safety Standards (for safe growing, harvesting, packing and holding of fruits and vegetables for human consumption), Hazard Analysis & Risk Prevention Plan requiring every food facility to implement a written plan with respect to the security of food products incorporating cGMP related to the product, a Foreign Supplier Verification Program which would require importers to perform risk based foreign supplier verification activities to ensure food imported complies with FDA regulations and Third Party Accreditation where the FDA will grant foreign companies who are accredited the power to investigate.

[3] Defined in § 201 (s) Food, Drugs & Cosmetics Act. See 21 CFR Part 170, 172 and 173 for a list of food additives.

[4] See 21 CFR Parts 182 and 184.

[5] See 21 CFR Part 70

Old labelling                                                                New labelling

fda-labelling-newSource: FDA website

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