Month: May 2019

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

Food Labels

In order to market food products in USA, the manufacturers and distributors must be registered with FDA and their product labels must be FDA compliant.

FDA is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries.

FDA does not pre-approve product labels, so it is the responsibility of the food manufacturers to ensure compliance. To facilitate that, FDA has detailed comprehensive food labeling regulations. These regulations provide details on each required component of the product label such as Product Name, Type, Quantity, Manufacturers info, Serving size, Nutrition facts, Foreign language etc. The minutest details such as text type, font size, placement is detailed in the guidelines.

In 2016, FDA introduced a new Nutrition Facts Table for all packaged foods with an aim to provide the consumers with more information about the foods they eat and then make an informed decision about consuming them.

The new changes highlight the calorie and servings information along with declaration of the percentage daily values of essential nutrients. The new requirements also modified the footnote to Nutrition Facts Table explaining the meanings and importance of % Daily Values. Some nutrients have been made mandatory while others are made optional.

The new requirement also changes the serving size to what people are actually eating than what they should be eating.

Both foods manufactured as well as imported into US are required to abide by the FDA’s labelling regulations.

FDA has provided the following dates regarding compliance with above nutrition label changes:

January 1, 2020 – For manufacturers with USD 10 million or more in annual food sales

January 1, 2021 – For manufacturers with less than USD 10 million in annual food sales

Since manufacturers still have time to begin using the new and improved Nutrition Facts label, we can still see both label versions on the products in market. However, soon the adoption of new label will be mandatory for all.

The list of labeling requirements is long, and it becomes rather confusing and tiring to go through each one of them and ensure compliance. To ensure a 100% compliance, manufacturers and labelers can use LMG’s label review service. It is fast, effective and economical.

Liberty Management Group LTD is one of the leading FDA consulting groups in the USA. LMG provides assistance with FDA registrations, label compliance, and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on May 08, 2019