Tag: Dietary Supplements

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

Dietary Supplement Advisory List

To market dietary supplements in US, manufacturers need to be FDA registered and ensure that their product ingredients are safe and approved by FDA.

In public interest, the FDA has unveiled an online tool, Dietary Supplement Ingredient Advisory List, that alerts the public when FDA identifies any ingredients that do not appear to be lawful ingredients in dietary supplements.

The new list can be used by consumers who do not wish to purchase any dietary supplements that contain questionable ingredients as well as manufacturers or distributors who wish to avoid selling supplements with such ingredients in their products.

Inclusion on the Dietary Supplement Ingredient Advisory List does not mean that FDA has determined the ingredient to be unsafe. Ingredients are added to this list on the basis of preliminary assessment enabling FDA to communicate to public while it completes a final determination regarding such ingredients. The reasons based on which an ingredient may be added to the list are:

  1. The ingredients appear to be excluded from use in a dietary supplement
  2. The ingredient does not appear to be a dietary ingredient, or does not appear to be an approved food additive or GRAS for use, or
  3. The ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been met

The list is not exhaustive, and ingredients may be added to or removed from the list as and when FDA deems fit.

This new list is a step in the FDA’s ongoing effort to strengthen and regulate the dietary supplement market and better protect consumers from unsafe products.

To ensure that the ingredients that the manufacturers are adding to their products or planning to add to their products are safe and not questionable, an ingredient and label review service of LMG can be availed.

Liberty Management Group Ltd has been serving clients across the world with FDA registrations, label and ingredient compliance and many more FDA regulations. Our technical experts have in-depth knowledge of FDA regulations and guide you every step of the way regarding all FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: May 22, 2019