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U.S. State-Specific Requirements for Bottled Water

U.S. State-Specific Requirements for Bottled Water

While FDA regulates bottled water sold in the United States, many state governments impose additional requirements for bottled water offered for sale within their jurisdictions.  For example, some states require licensing, certification, or additional labeling statements not specified in federal regulation.  These requirements apply to bottled water manufactured both inside and outside of the regulating state.

Every state’s requirements are different, so it can be especially difficult to market your bottled water in multiple locations.  Registrar Corp offers reports for each state that explain bottled water laws, making it easy to understand the requirements.

To receive one or more reports, simply complete the form below:

Please note that your information is saved on our server as you enter it.
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  • Price: $695.00
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  • (Valid until December 31, 2025)
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  • Registrar Corp recommends having the following documents for this submission:

    For the product:

    • Product name, number and size of retail containers, batch and lot numbers, any product identification codes, IFN number (if previously notified to FDA)
    • Countries in which currently marketed and duration
    • Quantity intended to be introduced to US market (by weight).
    • “Use by” date if in current inventory. If not in current inventory, the date you plan to introduce it into U.S. commerce. Indicate if it will be a one-time shipment or multiple shipments.
    • Name and location of manufacturing facilities
    • Distribution plan down to retail level, if available
    • Full quantitative formulation, list of all ingredients, amount of each ingredient per absolute amount (such as mg/kg or g/L)
    • Copy of the product label
    • Description of the product packaging
    • Summary of finished product testing results for most recent batch/lot at each facility:
      • Level of each nutrient required by 21 CFR 107.100
      • Level of any other nutrient added by the manufacturer in units per 100 kcal
      • Explanation of any deviation for a specialized formula that may not meet all requirements but is appropriate for dietary management of a specific disease or disorder
    • For powdered formula, a summary of finished product testing results for the most recent batch/lot at each facility:
      • For Cronobacter : 30 samples, with each sample being 10 grams
      • For Salmonella : 60 samples, with each sample being 25 grams
      • Description of test method used and copy of the method (e.g., certificate of
        analysis with information listed in 21 CFR 117.165(b)(2) from a qualified laboratory)

    For each manufacturing facility:

    • Certification of established current GMP designed to prevent adulteration, including quality control procedures and in-process controls, and testing required under the cGMP
    • Schematic diagram (i.e. process flow diagram) with processing times and temperatures, written narrative that includes a summary of process flow, heating and processing conditions, and critical control points
    • FDA Food Facility Registration Number
    • If facility has not received an FDA inspection:
      • Date of last inspection by the relevant government authority, or
      • Third party audit conducted by a qualified auditor on behalf of the government authority
      • Summary of the findings, standards/regulations against which the inspection was conducted, and any actions taken by the manufacturer in response
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Promemoria

La U.S. Food and Drug Administration (FDA) richiede che tutte le aziende alimentari, farmaceutiche e di dispostivi medici rinnovino le proprie registrazioni FDA tra il 1° ottobre e il 31 dicembre

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Il periodo di rinnovo per la registrazione alla U.S. FDA è TERMINATO il 31 dicembre 2024

Se non avete rinnovato entro la scadenza, dovete ri-registrarvi presso la FDA.

Ri-registratevi o verificate se la vostra registrazione è stata rinnovata per il 2025:

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