In Hemp 107, we discuss the legal protections afforded products made from industrial hemp and how the Department of Justice and the Food and Drug Administration have attempted to violate federal law to keep CBD off the market at the behest of Big Pharma.
All parts of the cannabis plant defined as industrial hemp were made legal by the Agricultural Act of 2014.
The Controlled Substances Act as it applies to cannabis was significantly decreased in scope by Congress passing the Agricultural Act of 2014 (sometimes called the “2014 Farm Bill”) which was signed into law by President Barack Obama on February 7, 2014, the applicable portion of which is codified in 7 U.S.C. § 5940 entitled “Legitimacy of Industrial Hemp Research.”
The Legitimacy of Industrial Hemp Research Provision of the Agricultural Act of 2014, 7 USC §5940, states in pertinent part,
“(a) . . . a State department of agriculture may grow or cultivate industrial hemp if–
“(1) the industrial hemp is grown or cultivated for purposes of research conducted under an agricultural pilot program or other agricultural or academic research; and
“(2) the growing or cultivating of industrial hemp is allowed under the laws of the State in which such institution of higher education or State department of agriculture is located and such research occurs,”
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“(b) . . . In this section:
“(1) . . . The term “agricultural pilot program” means a pilot program to study the growth, cultivation, or marketing of industrial hemp—
“(A) in States that permit the growth or cultivation of industrial hemp under the laws of the State; and
“(B) in a manner that—
“(i) ensures that only institutions of higher education and State departments of agriculture are used to grow or cultivate industrial hemp;
“(ii) requires that sites used for growing or cultivating industrial hemp in a State be certified by, and registered with, the State department of agriculture; and
“(iii) authorizes State departments of agriculture to promulgate regulations to carry out the pilot program in the States in accordance with the purposes of this section.
“(2) . . . The term “industrial hemp” means the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.
“(3) . . . The term “State department of agriculture” means the agency, commission, or department of a State government responsible for agriculture within the State.”
Defining industrial hemp as any part of the cannabis plant with a Delta-9 THC level not exceeding 0.3 percent on a dry weight basis was drawn from an arbitrary standard.
A THC content of 0.3 percent or less is too low to produce a euphoric high. In fact, any THC content not exceeding 1.0 percent is too low to produce any noticeable euphoric effect. The 0.3 percent cutoff was admittedly an arbitrary standard drawn from a 1976 taxonomic report by Ernest Small and Arthur Cronquist, two Canadian plant scientists who wrote in Taxon,
“It will be noted that we arbitrarily adopt a concentration of 0.3% Delta 9-THC (dry weight basis) in young, vigorous leaves of relatively mature plants as a guide to discriminating two classes of plants. This is based on standard-grown material in Ottawa in gardens, greenhouses and growth chambers, and of course on our analytical techniques. Dr. C.E. Turner, who has conducted extensive chemical analysis of Cannabis at the University of Mississippi, has agreed (pers. com.) that this is a reasonable figure to discriminate two classes of plants. We found that generally approximately 2% of the dry weight of young leaves of mature plants, or of the average dry weight of the softer parts of the female flowering plant (leaves, small twigs, flowers) is comprised of cannabinoids. Since CBD (cannabidiol, the most common non-intoxicant cannabinoid) and THC collectively, usually compose the bulk of the cannabinoids present, one can crudely adjust literature reports of cannabinoid concentration for comparison with our values on the basis that the concentration of CBD and THC should sum to roughly 2%.” See Ernest Small and Arthur Cronquist, Taxon, Vol. 25, No. 4 (Aug. 1976), pp. 405-435, 408.
Arthur Cronquist is famous for developing a taxonmic classification system for flowering plants called the Cronquist system.
There has been quite an evolution in Cannabis cultivation since Small and Cronquist compiled their report. THC has reached levels over 28 percent in plants with less than 1 percent CBD, and CBD has reached levels over 17 percent in plants with less than 1 percent THC.
Acapulco Gold sold at some medical marijuana stores in Las Vegas has a THC level of 8.97 percent and a CBD level of 13.46 percent, the lowest THC level and the highest CBD level of any marijuana sold for medical and recreational purposes in Las Vegas medical marijuana dispensaries. (Note: PharmaXtracts sells a CBD flower with less than 0.3 percent THC and 12 to 17 percent CBD, when the hemp flower is in stock, but PharmaXtracts is regulated by a Hemp Handler’s License and not by a Medical Marijuana License.) It is unknown whether the present day Acapulco Gold is anything like the Acapulco Gold of the old days that actually came from Alcapulco that would have been readily available in 1976 when Small and Cronquist performed their research.
PharmaXtracts considers 0.3 percent an acceptable Delta-9 THC limit since we have no problem meeting it. CBD is legal because it is classified as industrial hemp if extracted from industrial hemp while maintaining a Delta-9 THC level not exceeding 0.3 percent. PharmaXtracts CBD is all extracted from industrial hemp, and has no THC, so our CBD is considered industrial hemp pursuant to 7 U.S.C. § 5940 (b) (2).
Congress intended to make CBD legal because it is “any part” of the cannabis plant with a Delta-9 THC level not exceeding 0.3 percent if it is extracted from any part of the cannabis plant with a Delta-9 THC level not exceeding 0.3 percent.
On December 14, 2014, the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2013 made it legal to market CBD extracted from industrial hemp. This did not please some people at the Drug Enforcement Administration, for in response, the DEA published the Establishment of a New Drug Code for Marihuana Extract (spelling it "marihuana" which Anslinger falsely claimed was derived from the word “mallihuan,” an Aztec word for “prisoner”) and created a new code number under the Controlled Substances Act for “marihuana extract” (referred to as the “Final Rule”).
Harry J. Anslinger was the first Commissioner of the U.S. Treasury Department's Federal Bureau of Narcotics after being juiced into that position by his uncle, Treasury Secretary Andrew Mellon, said to be the richest man in America. Anslinger served as Commissioner from August 12, 1930 until he was forced into retirement when he turned 70 years old on May 20, 1962. AP Photo.
According to the DEA, “extracts of marihuana will continue to be treated as Schedule I controlled substances,” and according to the DEA, “if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code [for marihuana extract, DEA drug number] 7350.”
Amid considerable push back, the DEA backed down, sort of, and on March 14, 2017, the DEA issued a “Clarification of the New Drug Code (7350) for Marijuana Extract” which states in pertinent part,
“The new drug code (7350) established in the Final Rule does not include materials or products that are excluded from the definition of marijuana set forth in the [Controlled Substances Act (“CSA”)].
“ The new drug code includes only those extracts that fall within the CSA’s definition of marijuana.
“If a product consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360).
* * * *
“Because recent public inquiries that DEA has received following the publication of the Final Rule suggest there may be some misunderstanding about the source of cannabinoids in the cannabis plant, we also note the following botanical considerations. As the scientific literature indicates, cannabinoids, such as tetrahydrocannabinols (THC), cannabinols (CBN) and cannabidiols (CBD), are found in the parts of the cannabis plant that fall within the CSA definition of marijuana, such as the flowering tops, resin, and leaves. According to the scientific literature, cannabinoids are not found in the parts of the cannabis plant that are excluded from the CSA definition of marijuana, except for trace amounts (typically, only parts per million) that may be found where small quantities of resin adhere to the surface of seeds and mature stalk. Thus, based on the scientific literature, it is not practical to produce extracts that contain more than trace amounts of cannabinoids using only the parts of the cannabis plant that are excluded from the CSA definition of marijuana, such as oil from the seeds. The industrial processes used to clean cannabis seeds and produce seed oil would likely further diminish any trace amounts of cannabinoids that end up in the finished product. However, as indicated above, if a product, such as oil from cannabis seeds, consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360), even if it contained trace amounts of cannabinoids.”
The DEA’s classification completely ignored the safe harbor provided by the 2014 Farm Bill that removed hemp with a Delta-9 THC level less than or equal to 0.3 percent by weight from the definition of marijuana and which made the growing, harvesting, manufacture, and marketing of industrial hemp products, including CBD, perfectly legal. To get around this obvious flaw in the DEA’s reasoning, the DEA initiated plan B by soliciting the aid of then Secretary of the U.S. Department of Agriculture (“USDA”), Tom Vilsack, to more restrictively define industrial hemp so the DEA could still claim CBD is illegal.
Former Secretary of the United States Department of Agriculture Tom Vilsack.
In furtherance of this plan, on August 12, 2016, the USDA and the DEA issued a joint statement usurping Congress’s intent in passing the 2014 Farm Bill by unilaterally rewriting the federal definition of industrial hemp.
As drafted by Congress, Section 7606 of the 2014 Farm Bill, 7 U.S.C. §5940(b)(2), defines industrial hemp as follows:
“The term ‘industrial hemp’ means the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
The USDA and DEA’s definition of industrial hemp as contained in their Statement of Principles on Industrial Hemp (“SOP”), 21 C.F.R. §1308.11(d)(58), mangles this definition as follows,
“The term ‘industrial hemp’ includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis.”
The USDA's and DEA’s definition of hemp found in their joint SOP does two things in their attempt to outlaw CBD which, when extracted from industrial hemp, was made legal by the passage of the 2014 Farm Bill. First, the USDA and DEA’s definition of hemp tries to define industrial hemp as something to be used exclusively for fiber or seed, as if the only thing hemp is good for is to make rope and a highly nutritious cooking oil. Second, it tries to define industrial hemp as containing 0.3 percent or less of all tetrahydrocannabinol compounds, not just Delta-9 THC. The USDA and DEA’s SOP attempts to add the percentage weight of Delta-8 THC, Delta-7 THC, THCV, and THCA, all of which are not psychoactive, to the weight of the Delta-9 THC to make it that much harder for hemp to be grown with a total THC level not exceeding 0.3 percent by weight.
In addition, the SOP went on to say, “‘tetrahydrocannabinols’ include all isomers, acids, salts or isomers of tetrahydrocannabinols” just to make sure these additional THC cannabinoids were included in the percentage weight.
After Valsack refused to rescind the USDA’s definition of hemp to comply with the definition set forth in the 2014 Farm Bill, the Hemp Industries Association (“HIA”) sued the DEA in a petition for a review of its rules in an attempt to force the DEA to interpret Section 7606 of the 2014 Farm Bill as it was written, not as a few people in the DEA wish it had been written, if written at all. The DEA won its classification, but according to the Ninth Circuit, that classification does not apply to industrial hemp grown in conformance with the 2014 Farm Bill.
The United States District Court for the Ninth Circuit. c. 1905.
According to an Amicus brief filed in the United States Court of Appeals for the Ninth Circuit on January 11, 2018, in the case of Hemp Industries Association v. Drug Enforcement Agency, Case No. 17-70162 (Hemp III) (hereinafter referred to as “Amicus brief”), three United States Senators and 25 United States Representatives who sponsored and/or were instrumental in enacting Section 7606 of the 2014 Farm Bill (codified in 7 U.S.C. § 5940) advised the Ninth Circuit of their congressional intent in passing the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014. With respect to the definition of industrial hemp, the Amicus brief states,
“In enacting the Farm Bill, it was Congress’s purpose that industrial hemp and any derivatives, extracts, and uses thereof would be exempted from the definition of “marihuana” under the [Controlled Substances Act]. We know this because many of us helped draft the provisions and voted for them.”
So according to 28 members of Congress, when Congress wrote “any part of such plant,” it meant extracts taken from any part of a cannabis plant with a Delta-9 THC level not exceeding 0.3 percent are exempt from the federal definition of marijuana found in the Controlled Substances Act. Note: Marijuana is spelled “marihuana” in many federal statutes for reasons discussed in Hemp 102.
In Hemp III, the Ninth Circuit held the FDA did not have jurisdiction over cannabidiol (CBD) extracted from industrial hemp in conformance with the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014. The Ninth Circuit held, "The Agriculture Act contemplates potential conflict between the Controlled Substances Act and preempts it.” Id., p. 4. This means the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014 controls and takes precedence over the Controlled Substances Act. Hemp III is an unpublished memorandum opinion and has no precedential value outside the Ninth Circuit..
United States Senate Majority Leader Mitch McConnell (R-KY) represents a state historically associated with growing hemp.
On April 13, 2018, Republican United States Senate Majority Leader Mitch McConnell (R-KY) introduced the Hemp Farming Act of 2018 taking industrial hemp out of the purview of the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) and placing its control under the United States Department of Agriculture (USDA). The introduction of McConnell’s bill should not have be necessary in consideration of the Ninth Circuit’s opinion in Hemp III finding the Controlled Substances Act was preempted by the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014, but the finding in Hemp III has no precedential value outside the Ninth Circuit since it was an unpublished memorandum opinion, and other appellant districts could rule differently.
The power of the DEA to control CBD as a Schedule I or Schedule II drug and, therefore, regulate it under the Controlled Substances Act and prosecute people for possessing it was openly admitted by the DEA’s attorney during her argument in Hemp III not to apply if the CBD was extracted from industrial hemp pursuant to the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014.
Sarah Carroll, the DEA attorney, admitted,
"I think that you know if something really was outside [Controlled Substances Act] regulations either because it was from an exempt part of the cannabis plant or because it was truly within the four corners of the farm bill, then someone would have a valid defense in an enforcement proceeding."
What Ms. Carroll’s admission lacks is an acknowledgment the government has the burden of proof. A store owner accused of selling illegal CBD is presumed innocent and, as such, the CBD is presumed to have been extracted from industrial hemp grown in a state pilot program in conformance with 7 USC § 5940. The burden lies with the government to prove the CBD was not made from legally grown industrial hemp, a nearly impossible task. The language “truly within the four corners of the farm bill” is indicative of the skepticism and, perhaps, the disdain, those working for the DEA have for the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014 as if they cannot bring themselves to believe anything cannabis could possibly be legal and, therefore, any possessor of CBD must somehow prove their innocence.
The DEA’s argument before the Ninth Circuit in Hemp III was that any cannabis product needed to be assigned a drug identification number to comply with the same international treaty cited by President Richard Nixon’s administration as the reason for passage of the Controlled Substances Act, which we now know based on the admission of Nixon’s Assistant to the President for Domestic Affairs, John Ehrlichman, was to disrupt the Vietnam War protest movement and the leaders of the black power movement. See Hemp 103.
According to the Legitimacy of Industrial Hemp Research section of the Agricultural Act of 2014, 7 USC §5940(b)(2), industrial hemp is defined as follows:
“The term “industrial hemp” means the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.
In Senator McConnell’s proposed Hemp Farming Act of 2018, hemp is defined as follows:
‘‘(1) HEMP.—The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.
The language of 7 USC §5940(b)(2) makes clear “industrial hemp” is defined as “any part of cannabis sativa L., whether growing or not, with a Delta-9 THC concentration not exceeding 0.3 percent on a dry weight basis.” (Emphasis added.) So why did McConnell’s bill have to further define “any part” as “including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers?” The answer is because the DEA is not willing to accept the plain meaning of the language “any part” because it wanted to outlaw extracts from cannabis like CBD. Why? Because CBD really works, and CBD threatens the opioid drug pushing big pharmaceutical companies because CBD may offer a better alternative for relieving pain and treating a variety of other ailments.
The Department of Justice intentionally attempted to mislead Congress in its attempt to block passage of the Rohrabacher-Farr Amendment.
In Hemp 104 we discussed how passage of the original Rohrabacher-Farr Amendment forbid any federal funds from being used to prosecute medical marijuana growers, dispensaries, and patients in states that legalized medical marijuana. It was clear to all members of Congress that the Rohrabacher-Farr Amendment disallowed federal funds being used by the Department of Justice and its Drug Enforcement Administration to prosecute states that legalized medical marijuana thereby allowing those states to pass laws and regulations in furtherance of their medical marijuana legislation. It was also clear to all Congressmen, including House members who argued against passage of the Rohrabacher-Farr Amendment, that the amendment prevented the Department of Justice and its Drug Enforcement Administration from spending federal dollars to prosecute medical marijuana dispensaries and medical marijuana patients if they were acting in compliance with their state’s medical marijuana laws and regulations. Then came Patty Merkamp Stemier from the Appellant Section of the Department of Justice, Criminal Division, who attempted to thwart the intent of Congress and circumvent the law. Stemier had already shown herself to be less than honest.
Stemier previously wrote an internal Department of Justice memorandum containing “informal talking points,” that she intentionally leaked to House members prior to their voting on the Rohrabacher-Farr Amendment. Stemier figured certain members of Congress who were willing to protect the usage of medical marijuana in states that legalized it might have second thoughts about passing the Rohrabacher-Farr Amendment if they believed it would allow marijuana to be used for purely recreational purposes, so Stemier lied in her Rohrabacher-Farr Amendment talking points saying it could “in effect, limit or possibly eliminate the [Justice] Department’s ability to enforce federal law in recreational marijuana cases as well.” Stemier later admitted her talking points were “intended to discourage passage of the rider” but she then claimed her words did not reflect the Department of Justice’s “current thinking.” See Angell, Tom, “Leaked Document Shows Why Feds Believe They Can Ignore Medical Marijuana Law,” Trending High, August 5, 2015, marijuana.com/news/2015/08/exclusive-justice-department-admits-misleading-congress-on-marijuana-vote/.
When Stemier attempted to defeat passage of the Rohrabacher-Farr Amendment, she sought to mislead House members by expanding its scope. After the Rohrabacher-Farr Amendment became law, Stemier attempted to limit its scope. On February 27, 2015, Stemier wrote another internal Department of Justice memorandum to all federal prosecutors in which she said,
“. . . the Department’s position is that Section 538 does not bar the use of funds to enforce the [Controlled Substances Act’s] criminal prohibitions or to take civil enforcement and forfeiture actions against private individuals or entities. . .” See Gammon, Robert, “Depart of Justice Says Medical Marijuana Law Doesn’t Impact Prosecutions,” Scribd, scribd.com/doc/273620932/Depart-of-Justice-Says-Medical-Marijuana-Law-Doesn-t-Impact-Prosecutions
The Department of Justice’s absurd interpretation of the Rohrabacher-Farr Amendment was ridiculed by Judge Breyer and overruled in the case of U.S. v. MAMM, after which the Department of Justice quickly abandoned its appeal.
The Department of Justice’s position limiting the reach of the Rohrabacher-Farr Amendment to ban proceeding against the states but not against private individuals and entities was mocked by United States District Judge Charles R. Breyer in the case of United States of America v. Marin Alliance for Medical Marijuana, 139 F.Supp.3d 1039 (N.D. Cal. 2015) (U.S. v. MAMM). Judge Breyer considered whether enforcement by the Department of Justice of a prior injunction against a private provider of medical marijuana “must be consistent with the new directive of Congress in Section 538 . . . which prohibits the Department of Justice from expending any funds in connection with the enforcement of any law that interferes with California’s ability to implement [its] own State law that authorize[s] the use, distribution, possession, or cultivation of medical marijuana.” U.S. v. MAMM, 139 F.Supp.3d at 1040.
Judge Breyer enforced the Rohrabacher-Farr Amendment over the DEA's objection.
Judge Breyer’s decision states in pertinent part,
“. . . the Government initiated a forfeiture action against the property on which [Marin Alliance for Medical Marijuana (MAMM)] operated. . . . The forfeiture complaint cited this Court’s permanent injunction and MAMM’s violation of the [Controlled Substances Act] given that it was operating a medical marijuana dispensary. . . .
“Then the legal and factual circumstances changed. Section 538 . . . which has now been extended until December 11, 2015 . . . .
* * * *
“The plain reading of the text of Section 538 forbids the Department of Justice from enforcing this injunction against MAMM to the extent that MAMM operates in compliance with California law.
* * * *
“The Government’s contrary reading so tortures the plain meaning of the statute that it must be quoted to ensure credible articulation. Specifically, the Government contends that Section 538 proscribes the use of appropriated funds to ‘prevent’ states from ‘implementing their own’ medical marijuana laws. Such prohibited uses could include, for example, federal actions that interfered with a state’s promulgation of regulations implementing its statutory provisions, or with its establishment of a state licensing scheme. However, such uses do not include [Controlled Substances Act] enforcement actions against individuals or private businesses because such actions do not prevent a State from implementing its own laws . . . .
“. . . Where to start? An initial matter, perhaps, is the contradiction inherent in the Government’s assertion that enjoining any one medical marijuana dispensary . . . does not impede California’s implementation of its medical marijuana laws. . . .
“. . . [T]his drop-in-the-bucket argument is at odds with fundamental notions of the rule of law. It has never been a legal principle that an otherwise impermissible government intrusion can be countenanced because any one defendant is a small piece of the legal landscape. . . . Section 538 takes as a given that States implement their medical marijuana laws in the ways they see fit. . . . .
“. . . . To ‘implement,’ of course, means to ‘carry out, accomplish, to give practical effect to and ensure of actual fulfillment by concrete measures.’ Merriam-Webster Dictionary (2015). It defies language and logic for the Government to argue that it does not ‘prevent’ California from ‘implementing’ its medical marijuana laws by shutting down these same heavily-regulated medical marijuana dispensaries; whether it shuts down one, some, or all, the difference is of degree, not of kind. . . .
“. . . . [I]t comes as no surprise to the Court that the legislative history of Section 538 points in only one direction: away from the counterintuitive and opportunistic meaning that the [Department of Justice] seeks to ascribe to it now. Without exception, it appears that both the supporters and opponents of Section 538 in Congress at least agreed that the words mean what they appear to mean. . . .
“. . . . Even those who argued against the amendment agreed with the proponents’ interpretation of their amendment.
* * * *
“. . . . Having no substantive response or evidence, the Government simply asserts that it ‘need not delve into the legislative history here’ because the meaning of the statute is clearly in its favor. The Court disagrees.” (Emphasis added.)
After being shot down by Judge Breyer, the Department of Justice appealed his decision to the United States Court of Appeals for the Ninth Circuit, but then voluntarily dismissed its appeal on April 12, 2016. At some point the Government’s frivolous hounding of this particular California medical marijuana dispensary needed to stop.
It is outrageous that a high ranking Department of Justice official should pass a lie onto Congress in an attempt to effect the nation’s drug policies as either a favor to Big Parma or to protect the jobs of Department of Justice personnel who had been occupying themselves with attempting to shut down medical marijuana dispensaries.
Big Pharma controls the United States Food and Drug Administration.
In Hemp 104 we discussed how the United States Department of Health and Human Services patented synthetic CBD and then conducted no clinical trials and did nothing to move synthetic CBD to market. Did the Department of Health and Human Services patent CBD simply to keep CBD off the market to benefit big pharmaceutical companies? Most definitely.
Dr. Herbert L. Ley, Jr., was an original FDA whistle-blower.
Dr. Herbert L. Ley Jr. was the original FDA whistle-blower. Dr. Ley received his undergraduate degree, his M.D. (cum laude), and his Masters of Public Health from Harvard. Dr. Ley then worked for the Office of the Surgeon General, was Professor of Bacteriology and Chairman of the Department of Bacteriology, Hygiene, and Preventive Medicine at George Washington University, and Associate Professor and Chairman of the Department of Epidemiology and Microbiology at the Harvard School of Public Health before he was appointed by President Lyndon Johnson to become Chairman of the Food and Drug Administration. His honesty immediately led to controversy, and he resigned his position within a year and a half.
Dr. Ley had opposed fixed combination drugs, ordered 49 be taken off of the market, and told the drug companies, "unless there is a major change in the drug industry emphasis on sales over safety, the industry as we know it today may well be buried within the next several years in a grave it has helped dig.” Ley had a “gut feeling” his life expectancy at the FDA was "limited" and he told The New York Times he was under "constant, tremendous, sometimes unmerciful pressure" from the drug industry, and said, “The thing that bugs me is that the people think the FDA is protecting them - it isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day.” Dr. Ley has also been quoted as saying, “The FDA ‘protects’ the big drug companies and are subsequently rewarded, and using the government’s police powers they attack those who threaten the big drug companies.”
The FDA became even more conflicted with the passage of the Prescription Drug User Fee Act (PDUFA). PDUFA was passed in 1992 during George H.W. Bush’s administration. It provides that the pharmaceutical companies pay the majority of the FDA operating expenses. The FDA collects fees from drug manufacturers to fund new drug approvals.
One would have expected the pharmaceutical industry to oppose passage of PDUFA, but it was Big Pharma that lobbied for its passage seeking greater influence over the FDA. PDUFA needs to be renewed by congressional action every five years, but it keeps getting renewed making the FDA a slave of Big Pharma. Big Pharma guarantees the routine renewal of PDUFA by Big Pharma’s massive campaign contributions (recorded as $12,490,911 in 2018) to every Congressperson with their hand out.
Big Pharma paying the FDA to test their drugs has led to an increase in the number of drugs approved for every Big Pharma research and development dollar spent.
Because of this corruption, the FDA tends to hire former executives from the pharmaceutical industry. Many of those executives still have stock option interests in their old pharmaceutical companies which they may still collect while they work for the FDA. Big Parma’s lobbying of politicians has caused these obvious conflicts of interest to be waived, and now such conflicts have become routine.
Additional information of how Big Pharma controls the FDA comes from Dr. Raymond Woosley who was Vice President for Health Sciences at the University of Arizona when he was considered by President George W. Bush to be appointed Commissioner of the FDA. Dr. Woosley was not chosen to be the Commissioner of the FDA, and when later interviewed on PBS Dateline, he admitted, “It was very clear that people like myself, who care about drug safety, had become too controversial. Just like Senator Kennedy didn’t want to take somebody right out of the drug industry, the drug industry didn’t want someone like myself, who was going to focus on toxicity and side effects. So it became clear that I wasn’t going to be able to meet a broad enough constituency.”
Dr. Raymond Woosley was passed over for Commissioner of the Food and Drug Administration because he was not friendly enough with Big Pharma.
Dr. Woosley went on to tell Dateline, “I think the FDA is so grossly underfunded for its mission that it is out of balance because of user fees. User fees enable the agency to hire people to work for the industry.”
Given Big Pharma's influence over the FDA, it should be no surprise the FDA has taken so many steps to suppress cannabis based medical remedies.
PharmaXtracts sells the finest, purest CBD products at the lowest prices you will find anywhere. With over three decades of combined experience in the CBD industry, PharmaXtracts is a Band of Brothers who decided the CBD market needed a serious intervention. No longer could we stand by and let false information be perpetuated and insignificant dosages be taken by people in need of CBD’s many benefits. It was time for us to bring clarity to a once shady world.
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