Skip to content
envelope-open icon

sales@atlantiatrials.com

Clinical Trial Regulation USA

Dietary Supplement Regulation

In the United States of America, dietary supplements are regulated under the Dietary Supplements Health and Education Act (DSHEA), placing supplements under the food umbrella. With DSHEA came a definition for the terms “dietary supplement” and “new dietary ingredient” (NDI) and when a notification is required.

Find out more about different types of claims that be made in the USA regulatory field the specific clinical trial regulation services we offer for the USA and Canadian market.

Dietary Supplement Regulation
Clinical Trial Regulation USA

The Different Types of Health Claims You Can Make

GRAS- Generally Recognized As Safe

Atlantia can support you in the GRAS eligibility assessment of your food ingredient and the preparation and filing of your GRAS dossier.

New Dietary Ingredient

An NDI assessment of your ingredient and the preparation and filing of your dossier is required. We can support you in this.

Nutrient Content Claims

Describes the level of a nutrient in in a dietary supplement, using terms such as contains, provides, good source of, high, antioxidant and using terms such as free, low, more, reduced, and lite.

Structure/Function Claims

This substantiation can come in the form of a human clinical study. We can support you in designing the study to support your structure function claim.

Authorized Health Claim

Atlantia can support you in your authorized health claim petition to the FDA.

QHC- Qualified Health Claims

Qualified health claims (QHCs) are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. Atlantia can support you in your qualified health claim petition to the FDA.

Discuss Your Project
Take the First Step

Discuss Your Project

Looking for a research partner to conduct your clinical study? Our expert team is here to help. Get in touch today!

Atlantia's Solution

Atlantia can support regulatory applications for your product and its health applications in the US market.

The different types of health claims mentioned are approved by the FDA. As a world leading CRO with extensive expertise in regulation, we can help you in gaining FDA approval.

Whether its for GRAS, Atlantia can support you in the  eligibility assessment of your food ingredient and the preparation and filing of your GRAS dossier.

We can also support you in the NDI assessment of your ingredient and the preparation and filing of your dossier.

Substantiation of a structure/ function claim can come in the form of a human clinical study. We can support you in designing the study to support your structure function claim.

Atlantia can support you in your authorized health claim or qualified health claim petition to the FDA.

Atlantia's Solution
Our Process

Our Clinical Trial Process

Clinical Design

01. Clinical Design

Study design is a significant phase of any clinical research project. At Atlantia we can plan and guide you to design a successful trial depending on your focus: to increase sales, to obtain a health claim or as a proof of efficacy.

Read More

Trial Regulation

02. Trial Regulation

Our regulatory services include ethical submissions and approvals, our team takes into account the regulatory environment of the sponsor company to provide highly compliant study design.

Read More

Study Recruitment

03. Study Recruitment

Atlantia offers a proven ability to meet recruitment milestones. We have access to populations of all age groups and we are experienced in recruiting populations from 20 to 600 participants per trial on budget, and on time.

Read More

Study Conduct

04. Study Conduct

Our unique model maximises control, reduces the risk of data inconsistency, and brings a sense of assurance to our clients dealing with one competent organisation as opposed multiple contract research organisations.

Read More

Trial Analysis

05. Trial Analysis

At Atlantia your clinical data is at the centre of our service. When the samples are collected either during study visits or remotely they are prepared and stored at our facilities at -80*c, -20*C or refrigerated temperature and analysed by our research partners.

Read More

Study Reporting

06. Study Reporting

The Atlantia Clinical Research team provides a comprehensive study reporting service. Our statisticians adhere to ICH-GCP standards to produce a statistical study report, and if the client requests, a full clinical study report.

Read More

Health Canada

Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health.  

NHPs, often called "complementary" or "alternative" medicines, include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines, probiotics, and other products like amino acids and essential fatty acids. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.

To be legally sold in Canada, NHPs must have a product licence, an eight digit Natural Product Number (NPN). The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective. Atlantia can guide you in the requirements to obtain a NPN and support you in your product licence application.

Media & Resources

More From Atlantia

Case Studies

Case Studies

Our team has put together these clinical trial case studies in multiple topics to help you understand how we have assisted other sponsors in the past to tailor their clinical research programs.

Read More
Latest News

Latest News

Learn more about our company through our latest news. Articles have been worked on by members of our team. For media inquiries, please reach out to: marketing@atlantiatrials.com

Read More
Publications

Publications

Many of our clinical studies conducted are translated to published research papers in some of the top nutrition journals. You can discover our latest published work under this section.

Read More