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Exporting Your Dietary Supplements to the U.S.A. Successfully Navigating U.S. FDA Requirements Brought to You By
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Exporting Your Dietary Supplements to the U.S.A.Successfully Navigating U.S. FDA Requirements
Brought to You By
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, health\wellness, beauty, sports nutrition, functional foods, and beverage brands seeking to expand their product's sales and distribution.
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.
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
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: VitaminMineralHerb or other botanical; Amino acid(s)
• Generally, a dietary supplement is in tablet, capsule, powder, softgel, gelcap, or liquid form
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.
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
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-2015Let’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-billion2Euromonitor 2012
2
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
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.
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 SHIPMENTSU.S. Food and Drug AdministrationU.S. Department of Health and Human Services
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.
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.
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)
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 drugsCarbon blackCharcoal - NF XICudbearFerric chlorideFerrous sulfateLogwood, chips & extract - Logwood extract is still permitted in suturesSafflower (American saffron)
1FDA Color Additive Status List-December 2015
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
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.
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.
Product Labels- A Success Story
Before
After
Product Labels- A Success StoryBefore
Product Labels- A Success StoryAfter
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.
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.
For Additional Questions:• To partner with Nutritional Products International:
Contact: Scott Gould: [email protected]
• For Regulatory Questions:Contact:
Rosemarie Sunderland: [email protected]
