What is the best dietary supplement?

What are the labeling requirements for a dietary supplement imported in the US?

  • I need to import a Dietary Supplement manufactured in Italy into the United States. What are the steps to take in terms of labeling and Import? I already know I need to enter a "prior notification" in the FDA website.

  • Answer:

    FDA's labeling requirements are extensive, specific, and product-dependent, so there is no way to list them all in one Quora answer.  However, a good place to start is our list of the top 5 FDA labeling regulations to know: http://www.prweb.com/releases/fda-food-labeling/top-5/prweb12817596.htm Should you have any doubts about your product labeling, Registrar Corp offers a free label assessment to tell you whether or not your label is FDA compliant.  If your label needs revisions, Registrar Corp an also help to modify your label for compliance.  For more details, visit this page: http://www.registrarcorp.com/fda-food/labeling/?lang=en Other important FDA regulations to know when exporting dietary supplements to the United States: ·        Be sure to register with FDA before exporting products to the United States ·        When to file your Prior Notice depends on how your shipment is arriving to the United States: http://fda-news.registrarcorp.com/2014/08/fda-prior-notice-timeline/ ·        Know the regulatory statuses of ingredients. Dietary ingredients that were not present in the U.S. marketplace prior to October 1994 are considered "new" and are subject to notification requirements prior to marketing. ·        Unlike conventional foods, dietary supplements must include a U.S. address or phone number on their labels for consumers to report serious adverse events. All serious adverse event reports (AERs) must be submitted to FDA. ·         Inappropriate claims on labeling can cause a product to be detained and refused entry as an "unapproved new drug." Ensure no claims reference diseases on the label. ·        FDA requires dietary supplement labels to include a "Supplement Facts" chart. ·        Dietary supplements have alternate cGMP (current good manufacturing practice) requirements, including 100-percent identity testing for any dietary ingredients included in a product formulation. If you have any further questions regarding FDA's regulations for dietary supplements, contact Registrar Corp by e-mail at , by phone at +1-757-224-0177, or via our 24-hour Live Chat at http://www.registrarcorp.com/Livehelp.

David Lennarz at Quora Visit the source

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In 2010, FDA published the final rule governing import of all dietary supplements into the US. This rule consolidated the previous rules for GMP, documentation, packaging and labeling, ingredient testing, and adverse event reporting requirements. The rules describe in detail the import and marketing requirements for all dietary supplements prior to importing into the country or getting into the US market, if manufactured domestically. Additional requirements such as Foreign Supplier Verification Program (FSVP) and third-party audit program have been proposed to further regulate the import of dietary supplements into the US. This link will help you to learn more on the same. http://bit.ly/DietSupplement_FDAGuidelineshttp://bit.ly/DietSupplement_FDAGuidelines

Susan Partov

David,  VP of Registrar Corp, U.S. FDA Compliance Assistance has provided you with an  in-depth answer to your question. For more reading on this subject go through  http://www.naturalproductsinsider.com/articles/2005/07/overcoming-regulatory-hurdles-when-importing-dieta.aspxhttp://www.naturalproductsinsider.com/articles/2005/07/overcoming-regulatory-hurdles-when-importing-dieta.aspx

Kevin Agrawal

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