Regulatory Compliance Mastery: Dietary Supplements in North America and Europe

RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Introduction 

A nutraceutical product with quality as good as a pharmaceutical drug is possible when you apply the required GMP norms. Technological feasibility, safety, and cost efficiency are a few things to take into consideration when applying these GMP principles. This dietary supplement formulation training covers various instrumental topics to understand critical regulations.

If you are looking for training that is way beyond content-draining and one-sided seminars, this dietary supplement course is perfect for you. Whether you are a business owner or a manufacturing unit director, warning letters and injunctions are the last things you would wish for.

Get enrolled in this course and absorb all the useful insights related to the industry! 

Course Overview 

The main problem arises when manufacturers, distributors, and consumers don’t understand the efficacy of dietary supplements. Due to a boom in the market, producers are coming up with supplements that are deficient. 

Additionally, the ease of access and over-the-counter availability have diluted the importance of dietary supplements. This course is here to change the narrative and bridge the existing gaps.

Dietary supplement formulation training gives a comprehensive introduction to programming the entire manufacturing unit. Moreover, you will get to know the possible issues you might face while testing the products.

Here are some benefits of taking a course on regulatory compliance for dietary supplements:

•    Understanding FDA expectations
•       Knowing the rules and regulations to follow during the audits
•       Improving the GMPs to upgrade operations in the unit
•       Fundamentals of physical and chemical properties of the ingredients
•       Stability studies and categorization
•       Techniques to create a formulation that passes multiple checkpoints.

At World Compliance Seminar, we want to equip you with the best knowledge to pursue your career progressively. The detailed seminar is divided into two days and the first day consists of dietary supplements regulation in the US. As a result, the session will cover the following topics:

•       An Overview of Dietary Supplement
•       What is a dietary supplement all about?
•       Supplements vs. Pharmaceuticals
•       OTC Drugs
•       Conventional Foods
•       Medical foods
•       Natural products
•       Herbal medicinal products

Organizations and Regulatory Structure

·      FDA Assembly concerning Dietary Supplements Industry Groups

History of Dietary Supplement Regulation

•       Early History
•       DSHEA
•       Code of Federal Regulations

Manufacturing Considerations

•       Company & Facility Registration
•       GMP Requirements
•       GMP inspections

Dietary Ingredients

•       What qualifies as a dietary ingredient?
•       New Dietary Ingredient Notification (NDIN)
•       Old dietary ingredients vs. New dietary ingredients
•       Updated New Dietary Ingredient Guidance from FDA

Labeling Considerations

•       Display Panels & Layout
•       Supplement Facts Panel

Labeling Claims

•      Health claims
•       Disease Claims
•       Structure/Function claims
• ·     Disclaimers/Substantiation
•       Notification of labeling claims to FDA
•       Dietary Supplement Labeling Act

Advertising Considerations

•       FDA vs. FTC jurisdiction
•       Enforcement
•       Expressed vs. Implied Claims
•       Exercises & examples
•      Disclosures
•       Claim Substantiation
• Testimonials 

The second day of the seminar covers the food supplement regulations in the EU. Hence, the topics discussed are:

Overview

• ·      What is a food supplement?
• ·      Borderline products
• ·      Medicinal Foods

Organizations and Regulatory Structure

• ·      EU Regulatory Structure
• ·      Industry Groups

Supplement Regulation

• ·      Early History
• ·      Food Supplement Directive

Manufacturing Considerations

• ·      Company & Facility Registration
• ·      GMP Requirements

Dietary Ingredients

• ·      What qualifies as a dietary ingredient?
• ·      Ingredient safety
• ·      RDA vs RDI
• ·      DRV vs % Daily Value

Labeling Considerations

• ·      Display Panels & Layout
• ·      Labeling Claims
• ·      Health claims
• ·      Disease Claims
• ·      Reduction of Disease Risk Claims
• ·      Nutrition Claims
• ·      Notification requirements

Advertising Considerations

• ·      Enforcement
• ·      Claim Substantiation

Natural Health Product Regulation in Canada

·      What is a Natural Health Product?

Organizations and Regulatory Structure

• ·      Canadian Regulatory Structure
• ·      Health Canada
• ·      Canadian Health Products Directorate

Supplement Regulation

• ·      National Health Products Regulation
• ·      Differences between Canada and US
• ·      Supplements monographs
• ·      Requirements for pre-market approval

Manufacturing Requirements for Natural Health Products in Canada

•       Dietary Ingredients
•       Labelling Considerations
•       Advertising Considerations
•       Enforcement and Post-Marketing Surveillance
•       Review of Current Events and other Industry Topics
• Questions and Answers

Who will benefit from the course?

The course is designed to benefit professionals associated with different departments of dietary supplement manufacturing units, such as:

•       Quality testing and assurance: Helps them understand the basic parameters of testing the final product and by-products.
•       In-house auditors: Assists them in doing strict audits to avoid product recalls and FDA inspection failures
•       Suppliers and distributors: Makes them aware of licensing, marketing, and basic compliance related to dietary supplement distributions.
•       Labelling and packaging: Labels play an essential role in maintaining transparency about the ingredients. Hence, one must give the highest priority to the norms associated with labeling and packaging. This course consists of 3 rounds of discussion on this topic.

People Also Ask

Q1 Why is it difficult to pass audits on dietary supplements?

Dietary supplements consist of complex botanical and chemical ingredients. Hence, they are not as well defined as a pharmaceutical drug. The characteristics of the botanical ingredient might change depending on the climatic conditions and plant growth regulators. Hence, FDA needs to streamline the nutritional quotient by laying common regulatory norms to avoid major variations in the product.

Q2 What are common legal problems associated with dietary supplements?

Product recalls and warning letters are common issues faced by dietary supplement manufacturers. Moreover, the core problem lies in the lack of knowledge of GMPs for dietary supplements. Many manufacturers have been held accountable for adulteration that might harm consumers. A dietary supplements course will help in overcoming the knowledge gaps and passing FDA inspections successfully.

Q3 Does the course guide on registrations of the dietary supplements?

Yes. The course covers the issues faced by manufacturers during the registration of the entity. Since the regulations vary from place to place, it is essential to create a formulation that passes audits of various countries.