|
|
|
VitaPurity Responds to the FDA
|
|
|
|
The U.S. Food and Drug Administration monitors nutritional supplement companies to make certain they are not promoting their products for conditions that would cause those products to be categorized as drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act.
Since our inception in 2001, VitaPurity has been periodically reviewed by the FDA. We have always worked through any issues, established common ground and complied with FDA regulations as interpreted by each respective compliance officer.
VitaPurity believes that we can continue to balance the need to provide our customers with the all-important health, structure/function and nutrition information while, at the same time, remaining in compliance with FDA regulations.
|
|
|
|
 |
|
|
Just the Facts:
The FDA Webpage titled, Overview of Dietary Supplements states:
"By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product."
VitaPurity promotes our products within the framework of that FDA statement, and we feel we have been in compliance with it all along. However, in good faith and in the spirit of cooperation with the FDA, VitaPurity has voluntarily removed a tremendous amount of information that some FDA compliance officers had issue with both on our website and in our literature.
Below you will find documentation of the most recent communications between VitaPurity and the FDA. Normally, these relatively routine correspondences would be addressed and then filed away as part of the standard, day-to-day operating procedures of our company, they would not be made available to the public. However:
Due to the rise of several anti-health and anti-nutrition websites who have elected to post inaccurate and out-of-context information regarding the occasional warning letter from the FDA, we felt it necessary to provide you with both sides of the conversation.
VitaPurity encourages you to review these letters along with other materials presented here as a testament to our courteous and cooperative position toward the FDA and our steadfast commitment to you, our loyal customers, to provide you with truthful, accurate and necessary information on all VitaPurity products and to continue producing the very finest, highest quality nutritional supplements available anywhere in the world.
|
|
|
|
May 20, 2008
FDA Warning Letter SEA 08-18:
http://www.vitapurity.com/reference/fda/052008_sea0818/fda_052008.html
July 25, 2008 at approximately 1:37 PM
VitaPurity Response to FDA Warning Letter SEA 08-18:
VitaPurity President, Otto Roder, spoke by telephone to FDA Compliance Officer Lisa M. Elrand and discussed the concerns expressed in the FDA letter. During that call Ms. Elrand clarified the FDA's rules and regulations while Mr. Roder expressed VitaPurity's position with respect to acceptable language and reference materials used on our website, in advertising materials and on product labeling.
The conversation was pleasant and informative. Mr. Roder agreed to the changes proposed by Ms. Elrand and pledged VitaPurity's continued cooperation with the FDA. This call was documented and is on file at VitaPurity Corporation's Central Point, Oregon office.
May 21, 2010
FDA Inspection of VitaPurity Nutraceuticals' Headquarters:
On May 21, 2010 at approximately 11:00 AM FDA Inspector James W. Cartwright conducted a site inspection at VitaPurity Nutraceuticals' Home Office. The unscheduled inspection was initiated by FDA Compliance Officer Lisa M. Althar after she mistakenly assumed that VitaPurity had not responded to the May 20, 2008 issued FDA Warning Letter.
The site inspection was fairly routine and lasted approximately 3 hours. VitaPurity provided FDA Inspector Cartwright with all applicable labeling and materials he requested along with documentation of the misplaced July 25, 2008 VitaPurity response to the FDA Warning Letter for his review.
After the site inspection, VitaPurity President Otto Roder telephoned Ms. Althar and spoke with her regarding FDA Warning Letter SEA 08-18 and the subsequent site inspection. Ms. Althar requested that Mr. Roder write a follow-up letter again addressing the concerns presented by the FDA in their May 20, 2008 letter and send it to her attention.
May 22, 2010
VitaPurity's Follow-up Letter to the FDA as requested by Lisa M. Althar:
http://www.vitapurity.com/reference/fda/052210_followup/vp052210.html
July 19, 2010
FDA Response to VitaPurity's Follow-up Letter dated, May 22, 2010:
http://www.vitapurity.com/reference/fda/071910_fda_letter/fda071910.html
July 22, 2010
VitaPurity's Response to the FDA Letter dated, July 19, 2010:
http://www.vitapurity.com/reference/fda/072210_response/vp072210.html
|
|
|
** The above listed correspondence between the VitaPurity Nutraceuticals (a Division of VitaPurity Corporation) and the U.S. Food and Drug Administration are accurate copies of the originals maintained on file at the VitaPurity Corporate office in Central Point, Oregon.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
