Get the free Dietary Supplement Notification Letter - fda

This letter notifies the FDA about the marketing statements made for the dietary supplement Thins-Me, detailing its ingredients and intended benefits for weight management.

How to fill out dietary supplement notification letter

How to fill out Dietary Supplement Notification Letter

1. Begin by obtaining the Dietary Supplement Notification Letter form from the appropriate regulatory agency's website.
2. Fill in your personal or company information, including name, address, and contact details.
3. Provide details about the dietary supplement, including its name, ingredients, and intended use.
4. Include information on the manufacturing process, including the facility where the supplement is produced.
5. Specify any health claims made about the supplement, ensuring they comply with regulations.
6. Review all information for accuracy and completeness.
7. Sign and date the form where indicated.
8. Submit the completed letter to the designated agency, retaining a copy for your records.

Who needs Dietary Supplement Notification Letter?

1. Manufacturers and distributors of dietary supplements who wish to inform regulatory agencies about their products.
2. Companies planning to market new dietary supplements that require notification to ensure compliance with regulations.
3. Businesses looking to establish transparency and safety regarding their dietary supplements.

People Also Ask about

How do you use dietary supplement in a sentence?

I take no medications and only run-of-the-mill dietary supplements. Like other dietary supplements, the herbal extract is available without prescription, and is not subjected to the clinical testing standards applied to drugs. The patient listed her dietary supplements as vitamin D, probiotics, calcium, and magnesium.

What is a dietary supplement in English?

A product that is added to the diet. A dietary supplement is taken by mouth and usually contains one or more dietary ingredients. Examples of dietary ingredients include vitamins, minerals, herbs, amino acids, and enzymes.

What is an example of a dietary supplement?

He sells his paintings to supplement his income. = He supplements his income by selling his paintings. She began supplementing her diet with vitamins.

What is a good sentence for supplement?

Examples of supplement in a Sentence Noun the supplement to the encyclopedia First-class accommodation is available for a supplement. Verb She began supplementing her diet with vitamins.

What is an example sentence for dietary supplement?

The businessman was hawking a dietary supplement. There is insufficient evidence to justify recommending herbal and dietary supplements to help people to lose weight. Yet there have been few recent attempts to review the scientific literature on all available herbal and dietary supplements.

What is the required disclosure statement that must be on supplement labels?

The U.S. Food and Drug Administration regulations require that dietary supplement labeling include a descriptive name of the product stating that it is a "dietary supplement"; the name and place of business of the manufacturer, packer, or distributor; a list of ingredients; and the net contents of the product.

What is a new dietary ingredient notification?

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration (FDA) about these ingredients.

For pdfFiller’s FAQs

What is Dietary Supplement Notification Letter?

A Dietary Supplement Notification Letter is a formal communication that manufacturers or distributors of dietary supplements submit to the relevant regulatory authorities to notify them of a new dietary ingredient being introduced into the market.

Who is required to file Dietary Supplement Notification Letter?

Manufacturers and distributors of dietary supplements are required to file a Dietary Supplement Notification Letter when they introduce a new dietary ingredient that was not marketed in the U.S. prior to October 1994.

How to fill out Dietary Supplement Notification Letter?

To fill out a Dietary Supplement Notification Letter, include information such as the name and address of the manufacturer/distributor, a description of the dietary ingredient, and evidence of its safety and efficacy.

What is the purpose of Dietary Supplement Notification Letter?

The purpose of the Dietary Supplement Notification Letter is to ensure that regulatory agencies are informed about new dietary ingredients and their safety before they are marketed to consumers.

What information must be reported on Dietary Supplement Notification Letter?

The information that must be reported includes the name and address of the notifier, the name of the dietary ingredient, a description of how it is manufactured, and any safety information relevant to the ingredient.