Month: October 2023

US FDA Cosmetics Responsible Person

As per US FDA’s new regulation for regulating cosmetic industry – MoCRA (Modernization of Cosmetics Regulation Act of 2022), FDA now requires cosmetic companies to register their facility and list the cosmetic products with FDA.

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. Some examples are listed here.

MoCRA defines a Responsible Person as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Under MoCRA, the Responsible Person will have following responsibilities:

  • To obtain the relevant facility registration number or where small business exemption applies, the facility name & address, for each facility where its cosmetic products are manufactured or processed
  • Submit product listing for each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
  • Reporting serious adverse events associated with the use of cosmetic products in the US to FDA within 15 business days. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days.
  • To ensure and maintain records supporting adequate safety substantiation of their cosmetic products.

Liberty Management Group Ltd. provides assistance with Cosmetic Facility Registration and Cosmetic Product Listing.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

How does FDA regulate Dietary Supplements?

Manufacturers and sellers of dietary supplements in the US must comply with various FDA requirements to ensure the safety, quality and labeling of products being offered for sale in the US.

Key FDA requirements are:

Facilities manufacturing, packing, or storing dietary supplements must register with the FDA. Registration helps the FDA identify and monitor industry participants. Registration must be renewed biennially, and any changes to facility information must be updated.

Dietary supplement labels must be truthful and not misleading. Labels must accurately represent the product’s ingredients, content, and intended use. A Supplement Facts panel must be included on the label, providing information on serving size, ingredients, and nutrient content per serving. Allergen labeling is required to inform consumers of the presence of major food allergens, if applicable. Dietary supplement manufacturers are prohibited to make drug claims such as treat, cure, diagnose, or prevent diseases.

  • Current Good Manufacturing Practices (GMP):

Dietary supplement manufacturers are required to follow GMP regulations. GMP regulations establish standards for the production, packaging, labeling, and storage of dietary supplements. Compliance with GMP helps ensure that dietary supplements are manufactured consistently and meet quality standards. Facilities must maintain detailed records and establish quality control procedures.

  • New Dietary Ingredients (NDIs):

Manufacturers intending to use a new dietary ingredient (an ingredient not marketed in the U.S. before October 15, 1994) must submit a notification to the FDA at least 75 days before marketing the product. The notification must include evidence demonstrating that the NDI is reasonably expected to be safe for use in dietary supplements.

  • Adverse Event Reporting:

Manufacturers and distributors of dietary supplements are required to submit reports to the FDA regarding any serious adverse events associated with their products.

  • Imports:

The FDA regulates imported dietary supplements to ensure they meet the same safety and labeling standards as domestically produced supplements. Imported supplements may be subject to inspection and testing at US ports of entry.

  • Enforcement:

The FDA can take enforcement actions against manufacturers and distributors that violate regulations, including issuing warning letters, initiating recalls, and seizing products.

Liberty Management Group Ltd. provides assistance with FDA registration and label compliance.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us