Harmful and Potentially Harmful Constituents (HPHCs) Reporting Preparation Service

Service Description:

– Service is to assist persons reporting to FDA the quantities of harmful and potentially harmful
constituents (HPHCs) in tobacco products and tobacco smoke under section 904(a)(3) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387d(a)(3)).
– Service includes the statutory requirement for testing and reporting quantities of HPHCs,
HPHCs required testing, HPHCs required quantity reporting to FDA, When reports are
submitted to FDA, What information is reported to FDA, and How reports should be
submitted to FDA, and Preparation of 904(a)(3) Reports.
– Submission of 904(a)(3) Reports to FDA not included.
– HPHCs lab or 3rd party lab testing not included.

Requirements:

– Submit your HPHC list, if applicable, via email to
services@consultareinc.com
– Submit your material (HPHCs) specifications sheet or SDS or
Certificate of Analysis via email to services@consultareinc.com
– Submit your approved company logo and facility address to be
incorporated on the document via email to
services@consultareinc.com
– Harmful and Potentially Harmful Constituents (HPHCs) Reporting Preparation – Quantity 1 –
(Tobacco Product by Brand or By Quantity in Each Brand and Sub brand).
– Services are non-refundable.
– Google Meet – Screen Share for discussion. To be scheduled by
our
Compliance Team, if applicable.
– Recommendation and guidance given or implied are based on
best
practices and the adherence to a regulatory or certification
body
requirements or a Quality System and may or may not conform
to the requirements or the intended use or application.

Deliverables:

– Harmful and Potentially Harmful Constituents (HPHCs) Reporting Preparation – Quantity 1 –
(Tobacco Product by Brand or By Quantity in Each Brand and Sub brand). In .PDF format.

Delivery Date:

– 7 to 10 Business Days upon receipt of completed information
required for inputs.