Regulatory Compliance for Dietary Supplements in the US, EU and Canada: 2-day In-person Seminar

By: James Russell, Director, Regulatory Affairs for RJR Consulting, Inc
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Course Description:

A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States, EU and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in these countries.

This 2-day interactive live seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada and discuss how to verify that products are compliant with these regulations. Differences with food and drug regulation in these countries will be noted as well. We will also cover what qualifies as a dietary supplement or dietary ingredient, how to ensure GMP compliance as well as detailed requirements for labeling and acceptable marketing claims. An update on current events within the Supplement industry and the potential impacts to Manufacturers and Distributors in the US, EU and Canada will also be presented and discussed.

Who will Benefit:

  • Executives/Managers within Dietary Supplement or Natural Product companies
  • Regulatory Compliance Professionals in the Supplements or Natural Products area
  • Quality Assurance or Quality Control Professionals
  • Dietary Supplement or Natural Product Manufacturers & Distributors
  • Sales/Marketing Personnel in the Supplement or Natural Product Industries

Course Outline:

Day One (8:30 AM – 5:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Dietary Supplement Regulation in the U.S.
  1. Dietary Supplement Overview
    1. What is a dietary supplement?
    2. Supplements vs.
      1. Pharmaceuticals
      2. OTC Drugs
      3. Conventional Foods
      4. Medical foods
      5. Natural products
      6. Herbal medicinal products
  2. Organizations and Regulatory Structure
    1. FDA Structure regarding Dietary Supplements
    2. Industry Groups
  3. History of Dietary Supplement Regulation
    1. Early History
    2. DSHEA
    3. Code of Federal Regulations
  4. Manufacturing Considerations
    1. Company & Facility Registration
    2. GMP Requirements
    3. GMP inspections
  5. Dietary Ingredients
    1. What qualifies as a dietary ingredient?
    2. Old dietary ingredients vs. New dietary ingredients
    3. New Dietary Ingredient Notification (NDIN)
    4. Updated New Dietary Ingredient Guidance from FDA
  6. Labeling Considerations
    1. Display Panels & Layout
    2. Supplement Facts Panel
    3. Labeling Claims
      1. Health claims
      2. Disease Claims
      3. Structure/Function claims
      4. Disclaimers/Substantiation
    4. Notification of labeling claims to FDA
    5. Dietary Supplement Labeling Act
  7. Advertising Considerations
    1. FDA vs. FTC jurisdiction
    2. Enforcement
    3. Expressed vs. Implied Claims
      • Exercises & examples
    4. Disclosures
    5. Claim Substantiation
    6. Testimonials
Day Two (8:30 AM – 4:30 PM)
Food Supplement regulation in the EU
  1. Overview
    1. What is a food supplement?
    2. Borderline products
    3. Medicinal Foods
  2. Organizations and Regulatory Structure
    1. EU Regulatory Structure
    2. Industry Groups
  3. Supplement Regulation
    1. Early History
    2. Food Supplement Directive
  4. Manufacturing Considerations
    1. Company & Facility Registration
    2. GMP Requirements
  5. Dietary Ingredients
    1. What qualifies as a dietary ingredient?
    2. Ingredient safety
    3. RDA vs RDI
    4. DRV vs % Daily Value
  6. Labeling Considerations
    1. Display Panels & Layout
    2. Labeling Claims
      • Health claims
      • Disease Claims
      • Reduction of Disease Risk Claims
      • Nutrition Claims
    3. Notification requirements
  7. Advertising Considerations
    1. Enforcement
    2. Claim Substantiation
Natural Health Product regulation in Canada
  1. Overview
    1. What is a Natural Health Product?
  2. Organizations and Regulatory Structure
    1. Canadian Regulatory Structure
      • Health Canada
      • Canadian Health Products Directorate
  3. Supplement Regulation
    1. National Health Products Regulation
    2. Differences between Canada and US
    3. Supplements monographs
    4. Requirements for pre-market approval
  4. Manufacturing Requirements for Natural Health Products in Canada
  5. Dietary Ingredients
  6. Labeling Considerations
  7. Advertising Considerations
  8. Enforcement and Post-Marketing Surveillance
Review of Current Events and other Industry Topics
Questions and Answers

Meet Your Instructor

James Russell
James Russell,
Director, Regulatory Affairs for RJR Consulting, Inc.

Mr. Russell is the Director of Business Development and Regulatory Affairs for RJR Consulting Inc, a leading global regulatory consulting firm servicing the Life Science and Consumer Products industries. Mr. Russell has 13 years of experience in the Life Science field, encompassing foods, dietary supplements, pharmaceuticals and medical devices.James joined RJR Consulting in 2009 to assist companies with their global regulatory, manufacturing and distribution needs. Prior to RJR, Mr. Russell worked for a large life science distribution company with organizational responsibilities including regulatory, supply chain, business strategy and product data quality. Mr. Russell currently teaches on a variety of regulatory topics and is a participating member of the Regulatory Affairs Professionals Society (RAPS).

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Local Attractions:

Museum of Science & Industry (MOSI)
More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.

Salvador Dali Museum
Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.

Tampa Museum of Art
Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.

Craftsman House
Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.

Adventure Island
Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.



Busch Gardens
At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.

Florida Aquarium (The)
The Florida Aquarium gives visitors an all-access pass to the mysteries of the deep. Observe seahorses, lobsters, colorful fish, moray eels, gators, river otters, Australian sea dragons and many more. If you're feeling truly adventurous, take advantage of the "Swim with the Fishes" or "Dive with the Sharks" programs (advance reservations required). Kids will love the wide range of colorful and fun-filled interactive displays. The aquarium also sponsors ecotours aboard a 64-foot catamaran, affording patrons an opportunity to get even more up-close-and-personal with the sea. See website for complete list of attractions, calendar of events and more.

John's Pass Village
This scenic village with its nautical heritage and waterfront location offers an assortment of shops, boutiques, restaurants, water sports and entertainment. Located near the sands of Madeira Beach, John's Pass Village is renowned throughout the Bay Area as a site of good crafts and artisans, as well as casually comfortable seafood eateries. Weekends, the Village puts its best fin forward with street shows that include plenty of musical entertainment. From its boardwalk and marina, you can enjoy a free dolphin watch or take off aboard small cruise ships and fishing charters.

Lowry Park Zoo
Tampa's first zoo can trace its history back to the 1930s. In 1957, this collection of animals and birds was moved to its current location. Recognized as the "Number One Family-Friendly Zoo in the U.S." by Child magazine, Lowry Park Zoo features 2,000 animals on 56 acres of lush, natural habitats comprising seven main exhibit areas: Asian Gardens, Primate World, Free-Flight Aviaries, Florida Boardwalk, Florida Manatee and Aquatic Center, Wallaroo Station children's zoo, and Safari Africa. Gift shops, refreshment stands and cafes are located throughout the park.

Moccasin Lake Nature Park
If you've wondered how sun and wind supply power and water and how a host of other things work, this is the spot to find out. This environmental and educational center located at a 50-acre park is highly recommended not only for its low price, but also for its fine educational offerings. You can see a lake, upland forest and wetlands environment here and spot most of the plant and animal species native to this area. A mile-long nature trail winds through the park and an Interpretative Center features wildlife exhibits, displays, information, a classroom and a laboratory.