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GAS Notice (GRN) No. 935 https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventoryHogan LovellsHogan Lovell US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 T +1

How to fill out gras notice 935 l-carnitine-l-tartrate

How to fill out gras notice 935 l-carnitine-l-tartrate

1. To fill out GRAS Notice 935 for L-carnitine-L-tartrate, follow these steps:
2. Begin by understanding the purpose of the notice. GRAS stands for Generally Recognized As Safe, and this notice is submitted to the U.S. Food and Drug Administration (FDA) to demonstrate that a substance is safe for its intended use.
3. Gather all relevant information about L-carnitine-L-tartrate, including its composition, usage, and potential benefits.
4. Write a detailed description of the substance, including its chemical formula, structure, and properties.
5. Include information about the intended use of L-carnitine-L-tartrate, such as its function in food or dietary supplements.
6. Provide data and scientific studies that support the safety of L-carnitine-L-tartrate, including information on its absorption, metabolism, and potential side effects.
7. Include any relevant information on the manufacturing process, quality control measures, and potential contaminants.
8. Address any potential concerns or objections that the FDA may have, such as providing additional data or clarifying any ambiguous information.
9. Format the notice according to the FDA's guidelines for submission, ensuring that all required sections and supporting documents are included.
10. Submit the completed GRAS Notice 935 to the FDA, either electronically or through traditional mail.
11. Await a response from the FDA regarding the acceptance and status of the notice.
12. Please note that it is always recommended to consult with legal and regulatory experts familiar with GRAS notices and FDA regulations to ensure compliance and accuracy during the process.

Who needs gras notice 935 l-carnitine-l-tartrate?

1. GRAS Notice 935 for L-carnitine-L-tartrate may be needed by manufacturers and distributors of food or dietary supplements containing this substance.
2. These individuals or companies must demonstrate that L-carnitine-L-tartrate is safe for its intended use and does not pose any health risks to consumers.
3. The GRAS Notice serves as a way to validate the safety of the substance and gain the FDA's acknowledgement of its Generally Recognized As Safe status.
4. It is important to consult with legal and regulatory experts to determine if submission of the notice is necessary for your specific product, as well as to ensure compliance with FDA regulations.

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What is gras notice 935 l-carnitine-l-tartrate?

GRAS notice 935 refers to a submission concerning the status of l-carnitine-l-tartrate as Generally Recognized As Safe (GRAS) for its intended use in food products.

Who is required to file gras notice 935 l-carnitine-l-tartrate?

Food manufacturers or companies that intend to use l-carnitine-l-tartrate in their products may be required to file the GRAS notice.

How to fill out gras notice 935 l-carnitine-l-tartrate?

To fill out the GRAS notice, companies should provide comprehensive information about the substance, its intended uses, safety data, and any relevant scientific evidence supporting its GRAS status.

What is the purpose of gras notice 935 l-carnitine-l-tartrate?

The purpose of the GRAS notice is to inform the FDA that l-carnitine-l-tartrate is recognized as safe for its specified uses in food and to legally establish this status.

What information must be reported on gras notice 935 l-carnitine-l-tartrate?

The notice must report details such as the identity of the substance, intended use, safety assessments, manufacturing processes, and any literature supporting its safety.