Inspections, Compliance, Enforcement, and Criminal Investigations

Bio-Stasis International, Inc 8/31/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER
 
 
August 31, 2016
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
Laurence H. Griffin, President
Bio-Stasis International, Inc.
1281 North State Street A229
San Jacinto, CA 92583
support@virapress.com
 
 
Dear Mr. Griffin:                                                                                           
                                   
This is to advise you that in July 2016 the U.S. Food and Drug Administration (FDA) reviewed your web site at www.virapress.com, from which you take orders for your products, “ViraPress,” “Vitamin D-3,” and “Vitamin B-12.” FDA also reviewed your Facebook page at www.facebook.com/Virapress, your February 8, 2016 press release, published at www.prnewswire.com/news-releases/bio-stasis-international-unveils-dietary-supplement-to-enhance-the-immune-system-and-promote-health-300215932.html, and your comments on an online forum located at https://disqus.com/by/larry_griffin. Based on FDA’s review, we have determined that the claims on these websites promote “ViraPress,” “Vitamin D-3,” and “Vitamin B-12” for conditions that cause these products to be “drugs” under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B)-(C)].
 
The therapeutic claims on these websites establish that your products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body. As explained further below, introduction or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Your products, “ViraPress,” “Vitamin D-3,” and “Vitamin B-12” are marketed as sublingual products. Only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. Therefore, your above-listed products are not dietary supplements under section 201(ff) of the Act.
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs on your website include:
 
On your “Vitamin B-12” product page:
  • “Vitamin B-12 . . . enhances production of antibodies, so critical in any infection” 
On your “Vitamin D-3” product page:
  • “Deficiency of vitamin D-3 may encourage infections . . . If you have adequate blood levels [of vitamin D-3] it is possible to prevent any and all infections”
  • “Researchers have found that vitamin D . . . signals an antimicrobial response to some infections” 
On your “ViraPress” product page:
  • “Enhance Immunity and Promote Health”
  • “ViraPress™ is a natural dietary supplement for improving the immune system”
On your “Immune Protection” page:
  • “Enhance the Immune System against Zika, Dengue and Chikungunya Viruses”
  • “ViraPress will reduce the autoimmune symptoms of Guillain-Barre Syndrome”
  • “Taking ViraPress daily may fortify the immune system to attack a Zika infection from the Aedes mosquito. Fevers, with associated muscle and joint pain symptoms, have been reduced with Dengue and Chikungunya. These mosquito borne viral infections have had symptoms reduced within a day”
  • “ViraPress sublingual tablets contain small amounts of protein called glycoproteins, or cytokines . . . Glycoproteins regulate the immune system’s genes and effect activity against certain viral infections and autoimmune disorders”
  • “Testimonials . . . I am a middle aged man . . . and was a victim of a Dengue fever infection, in 2014. I was infected a second time with Dengue, the next year, and was incapacitated due to fever, with pain in muscles and joints [sic] . . . At the end of the second day, I took a ViraPress tablet and within a few hours could stretch muscles and actively move about [sic]” 
On your “About” page:
  • “Scientific research indicates that many autoimmune diseases, such as, hypothyroidism (Hashimoto’s Disease) and fibromyalgia are associated with a weakened immune function. Additionally, some viral infections, such as, shingles (chickenpox), dengue fever and chikungunya demonstrate prolonged symptoms often associated with a less than ideal immune response”
  • “The key to maintaining essential energy and good health is to provide one’s body with supplements that can aid in rebuilding a weakened immune system”
Examples of some of the claims that provide evidence that your products are intended for use as drugs on your Facebook page include:
  • “ViraPress . . . Enhance Immunity and Promote Health”
  • “ViraPress is a natural dietary supplement for improving the immune system”
Examples of some of the claims that provide evidence that your products are intended for use as drugs in your press release include:
  • “ViraPress™, a new and effective sublingual tablet which enhances the immune system and may increase protection while reducing fever symptoms from various viral infections”
  • “Specific modulating immune-enhancements, which are found in ViraPress™, utilize safe and natural occurring glycoproteins . . . which may regulate the immune system’s activity against certain mosquito-borne viral infections and some autoimmune conditions”
  • “ViraPress sublingual tablets contain glycoproteins that may modulate and enhance the immune system against viral infections . . . It is vital to take measures to protect one’s immune system by taking the tablets, one may improve resistance to subsequent viral infections, such as the Zika Virus, as well as with other outbreaks of other viruses on the rise [sic]”
Examples of some of the claims that provide evidence that your products are intended for use as drugs at an online forum located at https://disqus.com/by/larry_griffin include:
  • “Virapress [is] an all natural product which normalizes the immune which most of us do not have. Our experience with shingles is easing or elimination of symptoms in 2-5 days. We have individuals who were sent home from the doctor and told to tape their eye shot [sic] with not much encouragement. They started using the Virapress and started seeing results in about 8 hours and were system free in 5 days”
  • “ViraPress is an all natural product which allows the bodies [sic] own immune system to fight disease including Dengue fever”
  • “a friend was diagnosed with pulmonary fibrosis . . . I had a natural product created for her which stopped the progression of the disease in 10 days. Same results with most all autoimmune diseases, including MS. Cost of Virapress, the name of the product, $69.95”
Your products, “ViraPress,” “Vitamin D-3,” and “Vitamin B-12,” are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for its intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist with your firm’s products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that products marketed by your firm comply with all requirements of federal law and FDA regulations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which each such item will be corrected.
 
Please send your written response to this letter to:
 
Kelly Sheppard
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
If you have any questions regarding this letter, please contact Daniel W. Cline, Compliance Officer, at 949-608-4433 or Daniel.Cline@fda.hhs.gov.
 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
  
 
cc:
 
Laurence H. Griffin
Bio-Stasis International, Inc.
1712 Pioneer Avenue Suite 500
Cheyenne, WY 82001
 
Laurence H. Griffin
Bio-Stasis International, Inc.
5716 Corsa Avenue Suit 110
Westlake Village, CA 91362
 

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