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SUPPLEMENTS
FDA REGISTRATION of Dietary Supplements Facilities

FDA regulates both finished dietary supplement products and dietary ingredients.

The agency takes action against any adulterated or misbranded dietary supplement product after it reaches the market.

Dietary Supplements Facilities must renew their registration before December 31, 2020.

Qualified health claims (QHCs) are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim.

Consumer survey on dietary supplements revealed that 77 percent of Americans use them.

Dietary supplements imported into the United States must be safe and contain no prohibited ingredients, and all labeling and packaging must be informative and truthful.

All health claims must undergo review by the FDA through a petition process.

Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.”

FACILITY REGISTRATION

Companies can export or import Dietary Supplements and Dietary Ingredients to or from the United States as long as the facilities that produce, store, or otherwise handle the products are registered with the U.S. Food and Drug Administration (FDA), and prior notice of incoming shipments is provided to the FDA.

What’s new in 2020?

  • Your company must provide a DUNS Number
  • DUNS Number is free
  • Get a U.S. Toll Free Number for your labels (Available for a fee)

Click on the links below to get started for only $99.00 annual fee, including U.S. Agent Service.

Want or need to switch U.S. Agent? This is your last opportunity.

DIETARY SUPPLEMENTS
FACILITY REGISTRATION
LIMITED OFFER

$99.00 | ANNUAL SERVICE FEE

All domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control.

Your company manufactures or sells
  • Vitamins
  • Essential fatty acids (EFAs)
  • Branched-chain amino acids (BCAA)
  • Nutraceutical
  • Superfood
  • Fish Oil
  • Flaxseed
  • Omega-3 Fatty Acids
  • Weight Loss Conjugated Linoleic Acid (CLA)
  • Coenzyme Q10 (CoQ10)
  • Alpha-Lipoic Acid
  • Green Coffee

Contact ITB HOLDINGS LLC before you export or import dietary supplements and or ingredients.