US FDA Food Contact Substance (FCS)

How we can help you?
In this regulatory maze, it would be very difficult for the manufacturer to make sure the substance complies to the regulation and issue a certificate of compliance covering all the required details to a client in order to gain their confidence. Any incorrect act of the manufacturer would strictly lead to penalty from FDA considering these to be food contact substances affecting a huge population. It is best advisable to contact consultants who are experts in the field to first of all analyze the substance formulation, if complying with the FDA regulations and the 21 cfr part number it falls into or its CAS number. We as consultants can provide you the list of tests that needs to be conducted on the substance to demonstrate compliance where ever needed and a product review report explaining to which regulations the substance complies to.

How to issue a compliance certificate?
Manufacturers can issue a compliance certificate in compliance with Section 303 c (2) of the Federal Food and Drug Cosmetic act. This section clearly states that penalties are laid down by violation to the act. According to this section, manufacturers can provide “Letter of guaranty” to their clients that there substance is in compliance with the regulations laid down by the FDA. The suggested formats for the letter of guaranty are available as in 21 cfr 7.13 where the letter can be issued for specific shipment or delivery or be given as a part of the invoice or bill. Suggested formats for domestic and foreign manufacturers or agents are available in this section. There is no need to make the guarantee statement in the labeling.

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