Successfully Navigating U.S. FDA Requirements when Importing a new Dietary Supplement into the U.S. Presented by Nutritional Products International,Scott Gould and Rosemarie Sunderland on a live Webinar. For more information on marketing your product in the US visit www.nutricompany.com

1. Exporting Your Dietary
Supplements to the U.S.A.
Successfully Navigating U.S. FDA
Requirements
Brought to You By

2. About the Host-
Nutritional Products International
Nutritional Products International, provides domestic and
international product manufacturers with the regulatory, sales,
marketing, and product distribution services required to be
successful in the world's largest market -- The United States.
Nutritional Products International has the expertise,
infrastructure and contacts to assist manufacturers of high
quality nutritional products, natural products, healthwellness,
beauty, sports nutrition, functional foods, and beverage brands
seeking to expand their product's sales and distribution.

3. About the Guest Speaker-
Rosemarie Sunderland, CFS
Rosemarie Sunderland is a global regulatory expert and consultant for the
Food, Dietary Supplement, Cosmetic, and Drug industries specializing in
Product Labeling with over 10 years experience in taking products from
concept to market.
Rosemarie is thoroughly knowledgeable in both FDA and international
labeling and regulatory requirements ensuring that products are in
compliance with country-specific regulations so that they can be successfully
commercialized from the point of entry.
Rosemarie's expertise includes, but is not limited to Food, Beverages, Dietary
Supplements, Cosmetics, Homeopathic OTC Drugs, and OTC Drugs. She is an
active U.S. Agent for foreign companies wishing to do business in the U.S.A.,
as required by the FDA.

4. Topics to discuss today…
• How are Dietary Supplements defined in the U.S.A. and
who regulates them.
• FDA requirements for Dietary Supplements imported
into the U.S.A.
• Dietary Ingredients- Existing and New
• Top mistakes companies make when importing their
products.
• Product Labels- Before and After FDA Compliance
Reviews- A Success Story
• What’s next?
• Question and Answer Session

5. How are Dietary Supplements defined in the U.S.A.?
• A “dietary supplement” is defined in section 201(ff) of the Federal Food,
Drug, and Cosmetic Act (the Act) as a product intended to supplement the
diet.
• It contains one or more of the following dietary ingredients:
Vitamin
Mineral
Herb or other botanical;
Amino acid(s)
• Generally, a dietary supplement is in tablet, capsule, powder, softgel,
gelcap, or liquid form

6. How are Dietary Supplements defined in the U.S.A.? (cont.)
• A Dietary Supplement IS NOT
▫ conventional food
▫ sole item of a meal
• A dietary supplement may not contain an article that is an approved drug or
that is authorized for investigation as a new drug, and for which substantial
clinical investigations have been initiated and have been made public,
unless that article was marketed as a food or a dietary supplement prior to
its approval as a new drug or authorization as an investigational new drug.

7. How are Dietary Supplements defined in the U.S.A.? (cont.)
• A Dietary Supplement IS NOT
▫ A Drug
▫ A Medical Food
▫ A Nutraceutical
▫ A Homeopathic Drug

8. According to Nutrition Business
Journal, the size of the U.S. Dietary
Supplement Market in 2015 was
estimated to be approximately
$37.6 Billion1
1NBJ: ‘The US supplement industry is $37 billion, not $12 billion’ By John Bradley, Content Director & Editor-in-chief, Nutrition Business Journal, 01-Jun-2015
Let’s get this out of the way: The size of the US supplement industry is roughly $36.7 billion. The $11.8 billion estimate that TABS Group CEO Kurt Jetta announced last week is way off target, as were his attacks on
Nutrition Business Journal. http://www.nutraingredients-usa.com/Markets/NBJ-The-US-supplement-industry-is-37-billion-not-12-billion
2Euromonitor 2012
2

9. How are Dietary Supplements Regulated in the
U.S.A.?
• Dietary Supplements are regulated in the U.S.A. by the FDA
under the Dietary Supplement Health and Education Act
(DSHEA) of 1994
• Dietary supplements are not “approved” by the FDA.
▫ Before a firm markets a dietary supplement, the firm is
responsible for ensuring that
-the products it manufactures or distributes are safe
-any claims made about the products are not false or
misleading
-the products comply with the Federal Food, Drug, and
Cosmetic Act and FDA regulations in all other respects

10. FDA requirements for Dietary Supplements
imported into the U.S.A.
1. Dietary Supplement Manufacturers (both
domestic and foreign) must register their
establishment with the FDA. (Bioterrorism Act
of 2002)
▫ Foreign facilities require a U.S. agent.
2. FDA must be given advance notice on
shipments of imported food.

11. About the Host-
Nutritional Products International
Nutritional
Table Ref: PROTECTING THE U.S. FOOD SUPPLY/What You Need to Know aboutPRIOR NOTICE OF IMPORTED FOOD SHIPMENTS
U.S. Food and Drug AdministrationU.S. Department of Health and Human Services

12. FDA requirements for Dietary Supplements
imported into the U.S.A. (cont.)
3. Dietary Supplement Manufacturers must be in compliance
with Current Good Manufacturing Practices as outlined in
the Final Rule published by the Current Good
Manufacturing Practice (CGMP) In Manufacturing,
Packaging, Labeling, Or Holding Operations For Dietary
Supplements (72 FR 34752).
▫ Under the CGMP’s companies are required to test 100% of
dietary ingredients.
▫ Interim Final Rule published by FDA allows for manufacturers
to request an exemption if it can provide sufficient
documentation that reduced frequency of testing would still
ensure preservation of the identity of the dietary ingredient
being used as a component in the dietary supplement.

13. FDA requirements for Dietary Supplements
imported into the U.S.A. (cont.)
4. Dietary Supplements should be manufactured
using only Dietary Ingredients that have been used
in food supply as an article used for food in the
same chemical form as the ingredient you are
using prior to 1994. Otherwise, a New Dietary
Ingredient (NDI) Notification must be sent to the
FDA 75 days prior to marketing your Dietary
Supplement that contains the NDI.

14. FDA requirements for Dietary Supplements
imported into the U.S.A. (cont.)
5. Banned Substances:
▫ Ephedrine alkaloids
▫ Ingredients derived from Bovine sources must
be certified to be free of Bovine spongiform
encephalopathy (BSE)

15. FDA requirements for Dietary Supplements
imported into the U.S.A. (cont.)
5. Banned Substances (cont.):
Use of the following color additives is no longer authorized1:
Alkanet (Alkane)
Calcium carbonate - Allowed in drugs
Carbon black
Charcoal - NF XI
Cudbear
Ferric chloride
Ferrous sulfate
Logwood, chips & extract - Logwood extract is still
permitted in sutures
Safflower (American saffron)
1FDA Color Additive Status List-December 2015

16. FDA requirements for Dietary Supplements
imported into the U.S.A. (cont.)
6. Products must be labeled according to Dietary
Supplement Labeling Regulations. (Title 21 Code of
Federal Regulations Section 101.36 (21 CFR 101.36)).
▫ Dietary Supplements must bare a Statement of Identity
labeling the product as a Dietary Supplement.
▫ Products that contain added iron or iron salts for use as
an iron source must bear a label warning statement (21
CFR 101.17(e)(1)).
▫ Products must meet the allergen labeling requirements in
the Food Allergen Labeling and Consumer Protection Act
of 2004 (Pub. L. 108-282) which require the disclosure of
major food allergens.
1FDA Color Additive Status List-December 2015

18. Top mistakes companies make when
importing their Dietary Supplements.
1. Believing their products will be free from FDA
inspection upon arrival.
2. Not modifying their product labels to meet FDA
Dietary Supplement Labeling Requirements.
3. Making Claims that are considered “Drug Claims”
on their products.
▫ Drug Claims are those that imply that a product is
meant to diagnose, prevent, and/or treat a disease or
modify the structure or function of the body.

19. Top mistakes companies make when
importing their Dietary Supplements.
4. Not securing experienced import brokers
5. Not working with an experienced U.S.A.
partner that will ensure appropriate Sales and
Marketing strategies are in place to move all
product imported.

20. Product Labels- A Success Story
Before
After

21. Product Labels- A Success Story
Before

22. Product Labels- A Success Story
After

23. Conclusion
• Dietary Supplements are not regulated in the same way
across the globe.
• Understanding FDA regulations regarding Dietary
Supplements is key to a successful product
commercialization in the U.S.A.
• Knowing and abiding by FDA requirements for
importing Dietary Supplements in the U.S.A. will avoid
unnecessary delays.
• You must have the right partners to represent your
brand.

24. So are you ready to introduce your
brand to the U.S. market?
• Take advantage of the growing Dietary
Supplement category- with the best partner to
ensure your brand’s success.

25. For Additional Questions:
• To partner with Nutritional Products International:
Contact:
Scott Gould: scottg@nutricompany.com
• For Regulatory Questions:
Contact:
Rosemarie Sunderland: rosemariesunderland@gmail.com