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VitaPurity Responds to the FDA
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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.
Although it is becoming more difficult each year, 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.
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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 have had issue with both on our website and in our literature even though we believed we were already in full compliance.
Below you will find documentation of the communications between VitaPurity and the FDA. These routine correspondences would normally 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 on VitaPurity and because the FDA refuses to post our responses to their occasional warning letter, 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.
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May 20, 2008
FDA Warning Letter SEA 08-18:
https://vitapurity.com/reference/fda/052008_sea0818
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:
https://vitapurity.com/reference/fda/052210_followup
July 19, 2010
FDA Response to VitaPurity's Follow-up Letter dated, May 22, 2010:
https://vitapurity.com/reference/fda/071910_fda_letter
July 22, 2010
VitaPurity's Response to the FDA Letter dated, July 19, 2010:
https://vitapurity.com/reference/fda/072210_response
September 21, 2011
Teleconference Call with FDA Employees Lisa Elrand and Quyen Tien
On September 21, 2011 at approximately 10:00 AM, VitaPurity President Otto Roder engaged in a teleconference call with FDA Compliance Officer Lisa Elrand and FDA Senior Regulatory Review Officer Quyen Tien. The call lasted about 1 hour and 13 minutes.
Unfortunately, as oftentimes happens, we did not see eye-to-eye in several areas where Ms. Elrand and Mr. Tien alleged that VitaPurity was making disease claims where, in fact, we were not according to their own FDA guidelines (I encourage you to read the correspondence between our two companies below).
VitaPurity is a responsible and cooperative business that cares greatly about the welfare of our customers as we carefully attempt to operate within FDA guidelines. After all, it doesn't benefit us to fight against a giant governmental agency that could shut us down in an instant if it wanted to. Let me tell you, it can be quite a balancing act at times!
Even though there was significant disagreement between our interpretations of FDA guidelines, Mr. Roder again agreed to remove and/or change some of our product information through our website in the hope that it would satisfy Ms. Elrand and Mr. Tien.
September 30, 2011
VitaPurity's Follow-up to the September 21, 2011 Teleconference Call:
https://vitapurity.com/reference/fda/093011_followup
June 12, 2012
FDA Response to VitaPurity Follow-up Letter dated, September 30, 2011:
https://vitapurity.com/reference/fda/061212_fda_letter
July 18, 2012
VitaPurity's Response to the FDA Letter dated, June 12, 2012:
https://vitapurity.com/reference/fda/071812_response
December 11th and 12th, 2013
FDA Inspection of VitaPurity Nutraceuticals' Headquarters:
On December 11, 2013 at approximately 11:22 AM FDA Consumer Safety Officer Barbara J. Rincon began a site inspection at VitaPurity Nutraceuticals' Home Office. The unscheduled inspection was fairly routine and lasted approximately 9 hours. VitaPurity provided FDA Safety Officer Rincon with all applicable labeling and materials she requested, we also reviewed the website wording that Ms. Rincon stated might pose a problem with the agency if we did not address it.
Toward the end of the site inspection, Safety Officer Rincon provided the part of the FDA regulations that specifically applied to us and clarified what the agency wanted to see regarding our compliance. Safety Officer Rincon was courteous, respectful, informative and went "the extra mile" to try and establish a cooperation between the FDA and VitaPurity Nutraceuticals. No other inspector had ever done this before or since.
Ms. Rincon clearly wanted the FDA and VitaPurity to work together rather than to take an adversarial position with us. Although Consumer Safety Officer Rincon did not feel that any of the issues she brought up were extremely important she stressed that it did not mean that another inspector would necessarilly agree with her opinions. We were so impressed by Ms. Rincon that on December 30, 2013 we wrote the FDA a letter and included a commendation for her as a professional and courteous FDA investigator.
https://vitapurity.com/reference/fda/123013_inspection_response/vp_123013.pdf
January 30, 2014
FDA Acknowledges our December 30, 2013 Letter:
https://vitapurity.com/reference/fda/013014_fda_letter/fda_013014.pdf
February 27, 2014
VitaPurity Official Response to the December 11, 2013 Inspection:
https://vitapurity.com/reference/fda/022714_response/vp_022714.pdf
March 10, 2014
FDA Acknowledges our February 27, 2014 Letter:
https://vitapurity.com/reference/fda/031014_fda_letter/fda_031014.pdf
July 31, 2014
FDA Provides us the Inspection Report (EIR) from December 11, 2013:
https://vitapurity.com/reference/fda/073114_fda_eir_report/fda_073114.pdf
The above link is the final correspondence we received regarding the FDA inspection which commenced on December 11, 2013. Once we made the required corrections we received three (3) letters from the US Food and Drug Administration stating that no additional response was required from us. This was tantamount to the FDA having approved our operation.
Now, VitaPurity is not suggesting that the FDA certified us as having "passed the inspection" (the FDA never "passes" a nutritional supplement company, they simply leave them alone for a while). My point is simply this, that VitaPurity had satisfied the FDA by the changes we had made and this inspection was closed.
No structure/function claims had changed on the VitaPurity website for nearly three (3) years. Then a different FDA employee conducted an inspection in November, 2016 which led to an, unfortunately unpleasant new chapter in our relationship with the FDA...
May 12, 2017
FDA Warning Letter SEA 17-14:
https://vitapurity.com/reference/fda/051217_sea1714/fda_051217.pdf
May 26, 2017
VitaPurity Response to FDA Warning Letter SEA 17-14:
VitaPurity was disappointed that, in her warning letter SEA 17-14, FDA District Director Miriam R. Burbach failed to mention that the FDA found NO PROBLEMS with the POTENCY, PURITY and SAFETY of VitaPurity products. The only issues the FDA mentioned in their warning letter was:
1.) Whether or not VitaPurity could make certain claims and list certain references to support our products both on our website and on our supplement labels, and;
2.) That VitaPurity did not provide a newly requested manufacturing document (We promptly provided those documents to the FDA in our response to their warning letter and will now keep them at the ready for all future FDA inspections).
VitaPurity is dismayed that the FDA would choose to libel our products by calling them ''adulterated'' (when they are in fact NOT ADULTERATED) simply because we did not have a particular paper document. Unfortunately, the FDA often uses this kind of attack to strike fear into the heart of the general public. They use words out of context by changing their meanings to suit their needs. The average American citizen is NEVER made aware of this.
Please pay special attention to to the following excerpt from our May 26th response letter:
''To call our products “adulterated” without explaining {to the public} that this simply means that we did not have a piece of paperwork for your investigator makes your statement an absolutely fraudulent and libelous lie. This type of accusation is completely misleading to the American people.
Adulterated means "contaminated, toxic, dirty, unclean, etcetera". It has nothing to do with failing to provide a piece of paperwork (an MMR) to your investigator...I demand a retraction or a distinct clarification of that unfounded allegation from your website along with a public apology for your false accusation.''
I suppose it goes without saying that the U.S. Food and Drug Administration has not issued VitaPurity an apology nor have they posted any of our numerous response letters on their website.
VitaPurity encourages you to read our full response by clicking on the link below. For many years we have answered the often inaccurate and misleading accusations directed at us by the FDA. Disappointingly, it seems that the FDA is attempting to make it difficult, if not impossible, for reputable alternative medicine and nutritional supplement companies such as VitaPurity Nutraceuticals to operate within the United States.
We hope to hear from you soon, and we look forward to your comments and to your support.
https://vitapurity.com/reference/fda/052617_followup/vp_052617.pdf
June 30, 2017
FDA Response to VitaPurity's Letter dated, May 26, 2017:
https://vitapurity.com/reference/fda/063017_fda_letter/fda_063017.pdf
July 12, 2017
VitaPurity's Response to the FDA Letter dated, June 30, 2017:
https://vitapurity.com/reference/fda/071217_response/vp_071217.pdf
July 31, 2017
FDA Response to VitaPurity's Letter dated, July 12, 2017:
https://vitapurity.com/reference/fda/073117_fda_letter/fda_073117.pdf
August 13, 2017
VitaPurity's Response to the FDA Letter dated, July 12, 2017:
https://vitapurity.com/reference/fda/081317_response/vp_081317.pdf
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** 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.
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