Home
Forms Library
DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 - FDA

DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 - FDA 2025

DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 - FDA Preview on Page 1

Show details

4.6 out of 5

42 votes

The document is a Small Entity Compliance Guide by the FDA that outlines the legal requirements for labeling claims on dietary supplements, specifically focusing on structure/function claims versus disease claims. It explains the criteria for making these claims, the necessary substantiation and notification to the FDA, and provides guidance on distinguishing between acceptable structure/function claims and those that require prior FDA approval as disease claims. The document emphasizes compliance with regulations while clarifying that it does not create rights or obligations.

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

The best way to modify DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 - FDA in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Adjusting documents with our extensive and intuitive PDF editor is straightforward. Adhere to the instructions below to fill out DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 - FDA online quickly and easily:

Log in to your account. Log in with your credentials or register a free account to test the product before upgrading the subscription.
Import a form. Drag and drop the file from your device or add it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 - FDA. Easily add and highlight text, insert images, checkmarks, and icons, drop new fillable fields, and rearrange or remove pages from your document.
Get the DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 - FDA accomplished. Download your modified document, export it to the cloud, print it from the editor, or share it with other participants through a Shareable link or as an email attachment.

Make the most of DocHub, one of the most easy-to-use editors to promptly manage your documentation online!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is FDA title 21?

Passed by Congress in December 2016, the 21st Century Cures Act granted an alternative pay and personnel system, Title 21, to the FDA to improve the Agencys ability to recruit and retain scientific, technical, and professional experts in certain occupational series that support the development, review, and regulation

What comes from the Department of Health and Human Services?

Medicare and Medicaid together provide health care insurance for one in four Americans. HHS works closely with state and local governments, and many HHS-funded services are provided at the local level by state or county agencies, or through private sector grantees.

Is the FDA in the Department of Health and Human Services?

The FDA is a part of the Department of Health and Human Services.

Why would I get a letter from Department of Health and Human Services Medicare?

These letters confirm actions you took (or you asked us to do for you) regarding your secure Medicare account. We send letters when you: Create your new account (or ask us to create your account)

Why would I get a letter from the Department of Health and Human Services?

0:05 1:51 Well youve got mail. And not the fun kind from a secret admirer or a long-lost. Friend but from theMoreWell youve got mail. And not the fun kind from a secret admirer or a long-lost. Friend but from the health department. Now dont panic.

Why would health and human services come to my house?

0:14 1:48 The Health Departments goal here is to ensure that your living conditions are safe and healthy.MoreThe Health Departments goal here is to ensure that your living conditions are safe and healthy. Finally. They might visit to conduct a food safety inspection.

What is CFR 21 compliance?

The term 21 CFR refers to Title 21 of the Code of Federal Regulations (CFR), a list of operational requirements that an FDA-regulated manufacturing company must comply with to produce and sell products to consumers. You may also hear it referred to as CFR Title 21.

Why would the US Department of Health and Human Services send me a letter?

If you are involved in disputes regarding benefits or services, the HHS may send letters concerning appeals or hearings. These notices will typically outline your rights, the procedures to follow, and any deadlines that must be adhered to.

DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 - FDA 2025

Here's how it works