​The FDA's Threat To You

In February of 2016 the FDA sent letters to 8 companies that sell CBD and CBD products, PainBomb was one of those companies.  Let me take the opportunity to thank the FDA for increasing my business exponentially, and because of the lab results posted at their page (see 2016 letters), everyone can see that PainBomb products are superior.  With regard to the FDA letter, below are the two paragraphs of concern, and those two paragraphs prove that all of this unnecessary hullabaloo is a pathetic attempt by the FDA and pharma to kill public access to CBD, simply because it can replace so many prescriptions, without deadly side-effects.  In fact, the side-effects of CBD are very desirable:  Antidepressant, neuroprotectant, antioxidant, anti-psychotic, etc., the list is extremely impressive.

"FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if an article (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. 
 
The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex[1]. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the Act. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act, but you may present FDA with any evidence that has bearing on this issue."

PainBomb's Response to the FDA is below. 

U.S. Food and Drug Administration
CDER/OC/OUDLC
10903 New Hampshire Ave, WO51
Silver Spring, MD 20993-0002
FDAADVISORY@fda.hhs.gov
Response to Warning Letter Received February 5, 2016
RE:  CBD Products

February 24, 2016

Dear Ms. Bernstein,

Per your warning letter, all specified changes to the websites and literature have been made, and there are no longer "claims" made as to the efficacy of PainBomb+CBD or the Original PainBomb formula.  The list of conditions has been eliminated, and the following words were added:  "Money-Back Guaranteed to Relieve Nearly Every Type of Pain".  With regard to CBD, all specified changes were made, and actual study and article links were added to aid viewers who might be confused with regard to the informational source of a specific "claim".  

ON CBD AS A SUPPLEMENT:  THE CONCERN REGARDING ADULTERATED CBD AND CANNABIS PRODUCTS UNDERGOING TESTING BY GWPHARMA:

With regard to cannabidiol products NOT being unavailable as supplements, due to “CBD Products” being tested by GWPharma, the following is irrefutable evidence that those products are irreconcilably different from CBD and products being offered by PainBomb, as well as any other CBD company with even the slightest bit of integrity.  

1.  Sativex™, by GWPharma, was mentioned in your warning letter, and it contains a ratio of approximately 50/50 THC to CBD.  The other ingredients are propylene glycol, ethanol and peppermint oil.  To avoid verbosity, only propylene glycol is addressed below.  However, at the date of this writing, I have no information on the source/s of the cannabis extracts used in Sativex™.  That is of concern, as it's unknown whether this is a genetically modified cannabis; nor is the method of extraction known, so it's impossible to know if there are residuals remaining from solvent extraction.  Ethanol is typically a GMO corn product. 

PROPYLENE GLYCOL is a synthetic solvent.  The following information comes from the PROPYLENE GLYCOL MSDS and the ADDENDUM TO THE TOXICOLOGICAL PROFILE FOR PROPYLENE GLYCOL:
Special Remarks on Chronic Effects on Humans:
May affect genetic material (mutagenic).  May cause adverse reproductive effects and birth defects (teratogenic) based on animal test data.
Other Toxic Effects on Humans:
Hazardous in case of ingestion. Slightly hazardous in case of skin contact (irritant, permeator), of inhalation.
Potential Chronic Health Effects:
The substance may be toxic to central nervous system (CNS).  Repeated or prolonged exposure to the substance can produce target organs damage.  Slightly hazardous in case of skin contact (sensitizer).  
Special Remarks on other Toxic Effects on Humans:
Acute Potential Health Effects: Ingestion: It may cause gastrointestinal tract irritation. It may affect behavior/central nervous system (CNS depression, general anesthetic, convulsions, seizures, somnolence, stupor, muscle contraction or spasticity, coma), brain (changes in surface EEG), metabolism, blood (intravascular hemolysis, white blood cells - decreased neutrophil function), respiration (respiratory stimulation, chronic pulmonary edema, cyanosis), cardiovascular system (hypotension, bradycardia, arrhythmias, cardiac arrest), endocrine system (hypoglycemia), urinary system (kidneys), and liver.  
Chronic Potential Health Effects:  Prolonged or repeated ingestion may cause hyperglycemia and may affect behavior/CNS (symptoms similar to that of acute ingestion).  Inhalation: Prolonged or repeated inhalation may affect behavior/CNS (with symptoms similar to ingestion), and spleen.
NEUROLOGICAL EFFECTS:  A premature infant was exposed topically to burn dressing which contained propylene glycol and went into a coma. Cessation of the topical application of the burn dressing resulted in complete recovery.  It has been suggested that topical preparations containing propylene glycol should not be used in premature infants [Peleg, O. et. al., 1998].  
SYSTEMIC EFFECTS:   In humans, propylene glycol has caused skin and mucous membrane irritation when given orally.  It has induced skin sensitization reactions in several individuals and when taken orally, can also induce skin rashes. By the oral route, or by injection, propylene glycol has resulted in severe effects on the Central Nervous System and metabolic disruptions [BIBRA Working Group, 1996].
REPRODUCTIVE EFFECTS:  Investigators observed decreased fertility, and decreased ovary weights in maternal rats.  In the dams’ offspring, they noticed decreased body weights, reduced survival and litter size, slight delays in puberty onset, and histologic changes in liver and thymus in the F1 and F2 offspring [Carney et. al., 1999].
The fact that Sativex™ is targeted toward infants with epilepsy is beyond reproach, especially since propylene glycol is known to cause damage to the Central Nervous System.

2. Epidiolex™, also by GWPharma (and friends), is another drug targeting infants for Dravet’s Syndrome, or Severe Myoclonic Epilepsy of Infancy.  It contains sesame oil, ethanol, sucralose and strawberry flavouring.  As of the date of this writing, it is unknown whether this "flavouring" is a synthetic or natural element, and it is unknown whether any genetically modified organisms are present in the Epidiolex™ formula.  Only sucralose and strawberry flavoring are addressed in the following paragraphs:

SUCRALOSE:  The organochlorine (OC) sweetener sucralose is a synthetic trichlorinated disaccharide.  Simplified by Prevention.com's Jessica Girdwain, the following study results were presented in the Journal of Toxicology and Environmental Health, Part B: Critical Reviews:  "Early research said that sucralose passes through your GI tract undigested, so the theory was that it had little to no effect on you.  But new studies show that sucralose is actually metabolized, says study coauthor Susan S. Schiffman, PhD, an adjunct professor at North Carolina State University.  Enter a slew of problems, including:
Sucralose "reduces good gut bacteria:  Sucralose alters the amount and quality of those beneficial microbes that hang out in your belly (the same ones found in yogurt) by 50% or more. “Alteration in bacterial counts is associated with weight gain and obesity,” says Dr. Schiffman.
Makes meds less effective:  Sucralose limits the absorption of therapeutic drugs, such as those for cancer and heart disease, rendering them less effective.
Releases toxins: Many people bake with Splenda to reduce the calories in a recipe, but sucralose decomposes during baking, which releases potentially toxic compounds called chloroproanols.
May alter your body's responses:  Sucralose can alter insulin responses and blood sugar levels, has been associated with inflammatory bowel disease, and may even alter genes, the researchers note.
Now, let’s put the research in perspective. It was performed on rats, and rats are obviously not humans. However, the FDA’s approval of how much sucralose can be consumed safely is also based on rat studies, so it’s a fair comparison.
The research also used amounts of that are approved for use in food, not megadoses, and some adverse effects from sucralose were seen at very low levels. For example, says Dr. Schiffman, drinking the equivalent of less than a diet soda a day was found to reduce good gut bacteria, and two diet sodas a day could limit drug absorption.
Other research published in Trends in Endocrinology & Metabolism in 2013 found that sugar substitutes with sucralose are linked to type 2 diabetes, heart disease, metabolic syndrome, and obesity."
(http://www.tandfonline.com/doi/full/10.1080/10937404.2013.842523)

STRAWBERRY FLAVOURING: can contain any number of the following chemicals:  amyl acetate, amyl butyrate, amyl valerate, ethyl butyrate, various aliphatic acid esters, ethyl acetate, ethyl valerate, ethyl isovalerate, ethyl pelargonate,aldehyde C10, ethyl heptanoate, acetaldehyde, aldehydes C14 and C16, styralyl acetate, dimethyl benzyl carbinyl acetate, benzyl formate, phenyl ethyl isobutyrate, cinnamyl isovalerate, esters of colophony and benzaldehyde,  terpenyl isovalerate, isopropyl isovalerate, citronellyl isovalerate, geranyl isovalerate, benzyl isovalerate, cinnamyl formate, isopropyl valerate, butyl valerate, methyl allyl butyrate, cyclohexyl acetate, allyl butyrate, allyl cyclohexylvalerate, allyl isovalerate and cyclohexyl butyrate. (Environmental Working Group)
As Epidiolex was designed to treat Dravet Syndrome, Severe Myoclonic Epilepsy of Infancy, it’s abhorrent to use additives such as these.  This attack on infants - using these types of poisons - is unconscionable, and should be treated as intentional homicide if any deaths are linked to this drug.

3.  MARINOL (DRONABINOL):  Although this drug was introduced to the market in 1985 and approved by the FDA in 1992, it was not mentioned in the "FDA Warning Letter" directed at PainBomb, but I'm including this information for the consumer's benefit.  "Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is usually used when other drugs to control nausea and vomiting have not been successful. Dronabinol is also used to treat loss of appetite and weight loss in patients with HIV infection." (drugs.com)  Marinol's ingredients are listed at fda.gov as:  Synthetic delta-9-tetrahydrocannabinol, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, propylparaben, sesame oil, and titanium dioxide.

METHYLPARABEN AND PROPYLPARABEN:  Oct. 27, 2015 -- "A new study has found that chemicals called parabens can spur the growth of certain types of breast cancer cells. And they appear to be able to do this even in tiny amounts."  (WebMD.com)
•    Methylparaben (and BPA) can also interfere with the effectiveness of drugs used to fight breast cancer. (California Pacific Medical Center study)
•    Scientific studies have linked the chemicals to hormonal problems and reproductive health issues, among other problems. (California Pacific Medical Center study)
•    One in vitro study found that human sperm were not viable when exposed to parabens at concentrations of 1 mg/mL. (In vitro spermicidal activity of parabens against human spermatozoa)

FD&C BLUE NO. 1, FD&C RED NO. 40, FD&C YELLOW NO. 6:  Numerous independent studies have found that synthetic dyes – derived from petroleum - can cause hyperactivity and other behavioral impairments in children.  According to the Center for Science in the Public Interest, evidence shows dyes actually do and/or are suspected to:
•    Cause possible kidney tumors and possible effects on nerve cells (Blue No. 1)
•    Accelerate the appearance of immune-system tumors (Red No. 40)
•    Cause hypersensitivity (allergy-like) reactions (Red No. 40)
•    Trigger hyperactivity in children (Red No. 40)
•    Have caused adrenal tumors in animals (Yellow No. 6)
•    Be contaminated with cancer-causing chemicals (Yellow No. 6)
•    Cause severe hypersensitivity reactions (Yellow No. 6)
Ironically, synthetic THC products known as "Spice" or "K2" were sold and widely used recreationally until 2012, with some severe adverse health consequences, including death.  According to drugabuse.gov, "Synthetic cannabinoids can be addictive".  They "can also raise blood pressure and cause reduced blood supply to the heart, as well as kidney damage and seizures. Use of these drugs is associated with a rising number of deaths.
Psychotic effects include:
•    extreme anxiety
•    confusion
•    paranoia—extreme and unreasonable distrust of others
•    hallucinations—sensations and images that seem real though they are not
People who have used synthetic cannabinoids and have been taken to emergency rooms have shown severe effects including:
•    rapid heart rate
•    vomiting
•    violent behavior
•    suicidal thoughts
Synthetic cannabinoids can also raise blood pressure and cause reduced blood supply to the heart, as well as kidney damage and seizures.  Use of these drugs is associated with a rising number of deaths."  At least 12 deaths, according to studies.

On Feb, 14, 2016: 1,641 people reported to have side effects when taking Marinol.  Among them, 99 people (6.03%) have died. (eHealthme.com)  Common Side-Effects of Marinol (drugs.com):  Clumsiness or unsteadiness, dizziness, drowsiness, false sense of well-being, nausea, trouble with thinking, vomiting.

(Update, March 10, 2020:  3,775  people reported to have side effects when taking Marinol.  Among them, 267 people (7.07%) have died.)

VITAL DIFFERENCES BETWEEN PAINBOMB'S CBD AND SATIVEX™, EPIDIOLEX AND MARINOL, RENDERING SECTION 201(ff)(3)(B)(ii) of "THE ACT" [21 U.S.C. § 321 (g)(1)(B), INVALID:
PainBomb’s CBD is Non-GMO Project Verified, Organic and CO2 Extracted, and contains NO SYNTHETICS or additives of any kind.  Never would we add SYNTHETICS OR GMO's to our formulas - or accept them in CBD at all - and then try to present them as "health products", unlike the aforementioned pharmaceutical products approved by the FDA.  Our CBD does not contain 50% THC.  In fact, the amount of THC in our products would not register positive for THC on a Standard Drug Test, unlike Sativex™ and Marinol.  CBD in the form that we offer, causes NO ILL SIDE-EFFECTS.

ON MARKETING OF CBD AND CANNABIS PRODUCTS AS SUPPLEMENTS PRIOR TO TESTING OF SATIVEX™, EPIDIOLEX, AND MARINOL, POINT 2 WHICH RENDERS SECTION 201(ff)(3)(B)(ii) of "THE ACT" [21 U.S.C. § 321 (g)(1)(B), INVALID:
The first record of man’s use of Cannabis comes from the island of Taiwan, and dates back over 10,000 years to the Stone Age (Hemp: American History Revisited: The Plant with a Divided History, by Robert Deitch).  In the U.S., early 1800’s, Industrial Hemp was grown, and most tinctures were not being manufactured by established pharmaceutical companies, but by local apothecary shops throughout the country.  Because industrial hemp was legally being grown it was easily obtainable. (antiquecannabisbook.com)  Marketing materials from that time period, including logos and labels, are vast in number, pictured on this particular page there are 20.  This sets precedent for industrial hemp extracts being marketed nearly 100 years before Sativex’s study.  I won’t even bother to bring up the subject of the marketing of cannabis products through the ages.  My point has already been made.

Please send the contact information for the laboratory that tested PainBomb’s products, as there could clearly be a conflict of interest if the facility belongs to a pharmaceutical company, any of my competitors, any supplier of CBD to GWPharma, or any other pharmaceutical company that has submitted paperwork to test CBD as a drug.  In addition, please send a list of all pharmaceutical companies who have submitted paperwork to test CBD as a drug.  Lastly, please forward the official test results, as the information posted on the FDA website significantly differs from my analyses, and I’d like to show the conflicting results to the press and my legal advisors.

Below are a few links that will emphasize my reasons for NEVER seeking FDA approval for any product that I manufacture or sell - not in the past - and not in the future.  Those links are perfect examples of egregious errors in judgment by the FDA in allowing many drugs onto the market.  The deception and collusion taking place between the FDA, Big Pharma/chemical companies, the food, insurance and financial industries, and lawmakers is beyond reprehensible.  This deception includes the sick joke known as Obamacare, which causes taxpayers to pay for “death pills” for everyone.  Not one prescription is designed to heal anyone, yet treatments and supplements that can heal are suppressed, much like this campaign against CBD in its natural state.  We all know there’s No Money In A Cure.  Taxpayers have already paid 3.3 Billion Dollars for Pharma’s Death Machine to keep poisoning people using the vaccine industry alone (VICP).  That deception is not only allowed and condoned, it’s encouraged, and is even being written into law by the most immoral of lawmakers.  I, for one, am thoroughly disgusted.  And I’m disgusted that Wells Fargo, through Shopify, is allowed to freeze hundreds of my dollars indefinitely, in spite of the fact that CBD is legal and the option for them to do so is not in their Terms of Service.  Paypal did the same, and 8 months later they still have my money.  Never any chargebacks or disputes.  

In closing, before I’m targeted again by your organization, think carefully about the repercussions, credibility-wise.  Tell the “overlords” at pharma to pound sand, they can’t take CBD from the people.  Tell them also to clean up their industry, or suffer the consequences by way of people choosing to heal themselves using natural means without side effects like dementia, suicide and death.  They can buy my formula if they want something that actually works and doesn’t make people sicker, but they don’t.

Speaking of death, due to the number of natural health advocates dying suspiciously at alarming rates recently, mainly because they were set to expose the nagalese/cancer connection and the cure found in GcMAF, this is my declaration:  As an Indigenous American healer with every reason to live, I’m going on the record stating that I have absolutely no intention to commit suicide.  If anything happens to me take a good look at the “death industries” mentioned above as they would be linked somehow, I’m sure.

Sincerely, and with Integrity,
 
Karen I Butler
Founder/President, PainBomb LLC
Jemez Pueblo, NM

Dementia 'linked' to common over-the-counter drugs
Chemotherapy causes cancer: A case report of therapy related acute myeloid leukaemia…
Antidepressants and suicide.
Bad Reactions to Approved Drugs Cause 100,000 Deaths in U.S. Annually
Bioprospecting and Biopiracy:  Billions made, failure to compensate indigenous people fairly.
FDA Approves Briviact for Seizures February 19 (scroll down for ingredients/side-effects: contains talc)
J&J must pay $72 million for cancer death linked to talcum powder
Bad Drugs:  Your Resource for Adverse Reactions and Drug Recalls

We received another letter from the FDA which stated that our arguments did not suffice, although legally they do.  We were also told that a FOIA request would be required to obtain any information on the lab and testing.  Now, the FDA is able to use "Operation Chokepoint" to keep many legitimate businesses -- like PainBomb -- from collecting payments for products, which is just another of their pathetic gifts to pharma.  They do this by lumping legitimate CBD companies in with marijuana, although hemp and marijuana have been proven to have genetic differences, and CBD and THC are vastly different. 

Questions?  Call (970) 317-0234

Update April 2018, email for more information, karen@painbomb.com