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FDA Issues Warning Letter

On August 6, 2012, the U.S. Food and Drug Administration (FDA) issued a warning letter to a domestic food facility where noncompliance materially related to food safety was found during an inspection. FDA identified several violations, including failure to declare an allergen and labeling violations such as the layout of the nutrition facts, and the manner of declaration of ingredients.

Violations included:

  1. “…misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels for these products fail to declare the known major food allergen, wheat, as specified by the Act”
  2. “…misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition facts information is not in an appropriate format as defined within 21 CFR 101.9
  3. “…misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because it is fabricated from two or more ingredients but the labeling fails to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as well as sub-ingredients, as required by 21 CFR 101.4”
  4. “…misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition facts information is not in an appropriate format as defined within 21 CFR 101.9”[1]

The company was given 15 days to respond to the violations and specify the steps to be taken to correct them.  Failure to do so could result in penalties including fees, seizure, and injunction.   The warning letter also states that reinspection may be necessary to ensure compliance has been achieved and that fees may be assessed.

Under the Food Safety Modernization Act, FDA now has the authority to assess and collect reinspection fees.  FDA will bill for the hours required for the reinspection, without limit, at the rates of $289 per hour and $221 per hour, outside and inside the U.S., respectively.  “In FY 2011, FDA identified FSMA high- and non-high-risk domestic food facility inspections whose average costs were: $21,100 per high-risk food facility inspection and $14,200 per non-high-risk food facility inspection.  It is reasonable to assume that a reinspection may be equally costly.”[2]

Companies may avoid these costly reinspection fees by ensuring their product label comply with FDA regulations. Complying with FDA label regulations is not as simple as it may seem.  As seen in the warning letter, FDA labeling regulations can be complex. Registrar Corp assists clients in navigating the tangled web of FDA regulatory compliance. Our label review service provides detailed analysis of product labeling to ensure that each label incorporates the numerous regulations that govern the format and content of food labels.

For more information about labeling regulations and the Food Safety Modernization Act or any FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.


[1] U.S. Food & Drug Administration. “Inspections, Compliance, Enforcement, and Criminal Investigations” August 6 2012. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm314686.htm

[2] U.S. Food & Drug Administration. “2012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices,” August 2012. http://www.fda.gov/Food/FoodSafety/FSMA/ucm315486.htm