Registrar Corp | U.S. FDA News Updates

  • English
  • Español
  • 中文


Registrar Corp LinkedIn Registrar Corp Twitter Registrar Corp Facebook Registrar Corp Google+ Registrar Corp Youtube Channel Registrar Corp FDA News Blog
         

FDA Warns KIND LLC for Nutrient Claims



April 20, 2015 by David Lennarz

On March 17, 2015, the U.S. Food and Drug Administration (FDA) sent a warning letter to KIND, LLC regarding the labeling of four of its products: KIND Fruit & Nut Almond & Apricot, KIND Fruit & Nut Almond & Coconut, KIND Plus Peanut Butter Dark Chocolate + Protein, and KIND Plus Dark Chocolate Cherry Cashew + Antioxidants.  According to the warning letter, KIND claimed that these products were “Healthy and tasty, convenient and wholesome”, but none of the referenced products meet FDA’s criteria for labeling a product as “healthy”.

In order to use the term “healthy” or related terms on a product’s labeling, FDA requires that the product have a saturated fat content of 1g or less per Reference Amount Customarily Consumed (RACC), and no more than 15 percent of the product’s calories can come from saturated fat.   The referenced KIND products contain between 2.5g and 5g of saturated fat per 40g RACC, which exceeds both requirements.

Other KIND labeling issues cited in FDA’s warning letter include, but are not limited to:

  • Their use of “+” (plus) in two of the referenced product names.  FDA only allows labels to use “plus” if the product contains at least 10 percent more of the referenced nutrient than the recommended daily intake.
  • Their use of the phrase “antioxidant-rich.”  To use this phrase, FDA requires that the product contain at least 20 percent of the FDA’s established reference daily intake (RDI) for certain nutrients with recognized antioxidant activity.  The referenced KIND products only contain 15 percent of the RDI for Vitamin E.
  • The statement of their name and place of business is not complete and accurate, as there is no street address for the physical location of their firm on the label or in a city or telephone directory.

FDA gave KIND fifteen days to respond to the warning letter with a plan for corrective action.

The warning letter to KIND is one of 130 published FDA warning letters thus far in 2015, many of which deal partially or completely with labeling issues.   Labeling mistakes are one of the biggest issues when it comes to FDA compliance.  Registrar Corp offers a label and ingredient review service through which our Regulatory Specialists will review a product label’s compliance using the Code of Federal Regulations, warning letters, and other regulatory documents.  Clients receive a detailed report and a print-ready graphic file of their label that incorporates Registrar Corp’s suggested changes.

For questions regarding FDA regulations for food and beverage labeling or for more information about Registrar Corp label reviews, contact +1-757-224-0177 or via 24-hour Live Help at www.registrarcorp.com/livehelp.

 

24 Hour Live Help for FDA Questions

Enter your email address:


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

Registrar Corp
144 Research Drive
Hampton, VA 23666 USA
Phone: +1-757-224-0177
Fax: +1-757-224-0179
info@registrarcorp.com

 Home |
News |
© 2016 Registrar Corp