Inspections, Compliance, Enforcement, and Criminal Investigations

Biomedic Labs, LLC 10/28/15

  

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
 
 
VIA UNITED PARCEL SERVICE                                                                     
SIGNATURE REQUIRED
 
October 28, 2015                                                                                                             
                                                                                                                                         WL# 2-16
Biomedic Labs, LLC
Attn: Brad Custer
18911 E. San Tan Blvd
Queen Creek, AZ 85142
 
Dear Mr. Brad Custer:                                                                                   
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address www.biomediclabs.com and www.biomediclabsrx.com in July 2015 and has determined that you take orders there for these products: Serracor-NK, Serra Rx80, Serra Rx 260, N-Acetyl Rx and Vitamin D3 Rx. FDA has determined that your website promotes these products for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. 
 
The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introduction or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
 
Examples of some of the claims observed on your www.biomediclabs.com website include the following:
 
On the webpage titled “Pulmonary Fibrosis Plus Bundle”
 
“With over 11 years of results we have had about a 95% success rate in people using these products for this condition…”
 
Serracor-NK
  • “Serracor-NK helps pulmonary fibrosis by:

o    “Dissolving fibrin and scar tissues in the lungs”

o    “Improving breathing and reduce coughing”

  • “Serracor-NK not only rids the body of excessive fibrin and scarring in the lungs [sp] also controls the accumulation of fibrin that has the potential to accelerate scarring in lung tissues.” 
Serra Rx80
 
   “A highly concentrated form of serrapeptase, works synergistically with Serracor-NK to break-down scar tissue in the lungs and surrounding lung tissues.”
 
Vitamin D3 Rx
 
o    “Cholecalciferol 5,000 IU’s has been shown in many studies to help prevent or reduce chronic lung diseases such as asthma, cystic fibrosis, chronic obstructive lung disease and pulmonary fibrosis.”
 
The below claims are from the website http://www.biomediclabsrx.com/
 
Serra Rx 260
  • Serra Rx 260 aids and assists in the fight against the following conditions:
o    Dissolving Non-living Tissues Including Blood Clots, Scar Tissue, Cysts and Arterial Plaque.
o    Arthritis Pain and Inflammation
o    Blood Cleansing & Removal of Arterial Blockages
o    Highly Effective Anti-inflammatory & Pain Reduction Protocol
o    Fibrocystic Breasts & Uterine Fibroids
o    Sinusitis and Thinning Mucous Secretions
o    Lung Conditions: COPD, IPF, CF & Pulmonary Fibrosis
o    Dissolving Old & New Scar Tissue such as Peyronies...
o    Accelerated Healing Response, Post Surgery Recovery & Reduction of Scar Tissue
o    Relief from Sinus and Respiratory Build-Up of Mucus
o    Provides Potent Anti-Inflammatory and Fibrinolytic Properties
o    Chronic Sinusitis
o    To improve the elimination of bronchopulmonary secretions
o    Traumatic injury such as sprains and torn ligaments
o    Post-operative inflammation & healing
o    To facilitate the therapeutic effect of antibiotics in the treatment of infections
o    Cystitis and epididymitis 
 
On the webpage titled “Pulmonary Fibrosis Plus Bundle”
  • Serracor-NK and Serra Rx 80
o    “Serrapetase: For people suffering from pulmonary fibrosis Serrapeptase is a systemic enzyme that works in the lungs to dissolve scar tissue”
 
o    “Serrapeptase (Serracor-NK & Serra Rx 80) must be taken to dissolve scar tissue and inflammation in the lungs.”
 
o    “Serracor-NK & Serra Rx 80…breakdown and dissolve scar tissue and inflammation.”
  
On the webpage titled, “Cystic Fibrosis”:
  • Serracor-NK and Serra Rx 80 
o    “Among the best enzymes for removal of scar tissue are serrapeptase and nattokinase, which are found in Serracor-NK and Serra Rx 80.”
 
o    “Studies have shown that serrapeptase reduces scar tissue, improves tissue healing and significantly reduces inflammation.”
 
o    “Serrapeptase is used to dissolve non-living tissues to include: scar tissue, fibrosis, blood clots,…arterial plaque.”
 
o    “Serrapeptase may be particularly effective for those who have lung problems, as it clears out all of the inflammation, mucus and dead/scar tissue.”
  
On the webpage titled, “Multiple Sclerosis”:
  • Serracor-NK and Serra Rx 80
o    “Serracor-NK, Serra Rx 80 and other proteolytic enzymes break down the destructive immune complexes and can dramatically reduce MS symptoms…[r]egular supplementation with enzymes has been documented to halt the progress of degeneration associated with most stages of MS.”
 
o    “They are anti-fibrotic, meaning that they break down hard, fibrotic tissue, and in so doing, help prevent atherosclerotic plaqueing, hypertension and other cardiovascular diseases, thrombosis, blood clots…”
  
On the webpage titled, “COPD”:
  • Serracor-NK and Serra Rx 80
o    “New Hope for COPD patients, A Breakthrough Alternative Approach that Offers Relief and Results.”
 
o   “Biomedic Labs provides a product combination that has had a huge success for people suffering from pulmonary conditions and COPD.” “The products we are having great success with will treat your condition in multiple ways. The first and two… is Serracor-NK and Serra RX8…these products were designed and formulated to dissolve scar tissue that is being built up in lungs that is causing the fluid to fill the air sacks in the lung area.”
 
o   “Serracor-NK the Alternative Treatment for COPD” Dissolve fibrin and scar tissues in the lungs Improved breathing and reduce coughing
 
o    “Serracor-NK users report a significant improvement in breathing, reduction of coughing and mucus, and in some patients the discontinuing of assisted breathing machines or oxygen tanks.”
  • N-Acetyl Rx:
   “NAC has great potential…for preventing heart disease…cancer.”
  • Vitamin D3 Rx
o    “[O]ur last product for COPD”
o    “Vitamin D3 Rx is essential to help rebuild tissue in the lungs that has been damaged from scar tissue and bacteria.”
 
On the webpage titled, “Fibromyalgia”:
  • Serracor-NK (Relieving Fibromyalgia Pain With Serracor-NK)
o   “The enzymes in Serracor-NK have been clinically proven to fight pain; fibrosis, inflammation…”
 
On the webpage titled, “N-acetylcysteine”
  • N-Acetyl Rx 500mg
o    “Break up mucus in the lungs for conditions such as IPR, Bronchitis, emphysema and many other lung conditions”
o    “Help prevent heart disease”
o    “Prevent liver damage from acetaminophen toxicity”
o    Remove mercury from the body, improve impaired blood flow in smokers”
o    “Help prevent damage from oxidized LDL cholesterol”
o    “Help protect against cancer”
o    “NAC is being investigated in clinical trials to see if it prevents cancer in smokers.”
 
Claims in the form of testimonials found on the website www.biomediclabs.com that establish the intended use of these products as drugs include: 
  • On the webpage “Testimonials-Pulmonary Fibrosis IPF”
o    “I have been using Serracor NK and Serra Rx 80 for over 7 years now, to control the growth of scar tissue on my lungs. I was diagnosed with Pulmonary Fibrosis in 2007. The mortality for this disease is 3 to 5 years and there is no known cure. Your products have been a major factor in controlling the scar tissue growth. I would highly recommend these products to anybody who has the same disease. It is working.”
 
o    “About two months ago, I was diagnosed with pulmonary fibrosis. I was constantly short of breath... I began taking the supplements that were recommended by Brad at Biomedic Labs. The difference was amazing. Within two weeks I saw a change in my ability to breath[sic] without straining. The difference has been amazing.”
 
o    “20% improvement in “Lung Fibrosis within one & a half month. Amazing!!”
 
o    “I have been taking Serra Rx and Serracor NK, and Clear Lung for just about a year now.  I have not had a single lung infection where as, prior to being on this   regiment, I was experiencing infections every 3-4 months.”
 
o    “Using a combination of Serra Rx and Clear Lungs three times daily have kept my chronic cough under control—the first products that have really worked for me.”
 
o    “I have been using the Serracor-NK & Serra Rx 80 for about 5 months to help with my pulmonary fibrosis. My breathing and lung capacity have definitely improved.”
  • On the webpage “Testimonials – COPD-Chronic obstructive pulmonary disease”:
o    “I was diagnosed with COPD over 2 months ago. After 6 weeks on these products my pulmonary doctor says my test numbers no longer support a diagnosis of COPD.”
  • On the webpage “Testimonials – Fibromyalgia (FMS)
o    “This product saved my life. I have fibromyalgia which was always bad,… After a month of Serracor NK, 2 3X a day, I had No pain…I have recommended it to friends with fibromyalgia and with rheumatoid arthritis and it’s always worked…”
  • On the page “Testimonials - Arthritis Inflammation”:
o    “I have been using Serracor for several years. It has eliminated by arthritis, eliminated my atherosclerosis…”
o    “Using Serra Rx, I have had a marked decrease in pain level due to Osteoarthritis.”
 
Your products 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 Serracor-NK, Serra Rx 80, Serra Rx 260, N-Acetyl Rx, and Vitamin D3 Rx 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 their intended uses. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. 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. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen days, explain the reason for the delay and state the date by which the corrections will be completed.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
CAPT Dan Cline, Acting Director
Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.
 
 
Sincerely,
/S/                                                                                   
LCDR Steven Porter, Acting Director
Los Angeles District
 
Cc:
David M. Mazzera, Chief, Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413
Attn: FDA Correspondence

 

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