More FDA Warnings, Mislabeled CBD Products & Police Raids
Category : Noticias
- The FDA has issued more warning letters to hemp CBD companies for making unsubstantiated medical claims.
- A study published in the Journal of the American Medical Association indicated that 69 percent of hemp CBD products tested did not contain the amount of cannabidiol indicated on the label.
- Sporadic police raids continue to target CBD retailers in several states.
- A legal battle over the status of hemp-derived CBD looms in federal court.
A series of police raids in North Dakota has set the stage for a courtroom showdown regarding the legal status of cannabidiol (CBD), the non-intoxicating cannabis component with significant medical properties. Thus far, it’s not going well for purveyors of the claim that hemp-derived CBD is legal in all 50 U.S. states.
In October 2017, Northwest District Judge Robin Schmidt refused to dismiss drug trafficking charges against Falesteni Abuhamda, the owner of two North Dakota tobacco stores, which allegedly sold products containing CBD with very little or no psychoactive THC [tetrahydrocannabinol]. Abuhamda’s attorney argued that the CBD products were legal because the CBD oil was extracted from the stalk of industrial hemp.
But a forensic scientist with the state’s crime lab easily debunked this argument by stating the obvious: CBD is not found in any appreciable amount in hemp stalk. Rather it exudes from the resinous flowers and leaves of the cannabis plant. And, therefore, CBD is forbidden under the Controlled Substances Act, according to the Drug Enforcement Administration (DEA).
The Food and Drug Administration (FDA), which defers to the DEA on cannabis-related matters, considers CBD to be an experimental pharmaceutical undergoing evaluation. In early November, the FDA sent letters to several companies selling hemp-derived CBD products warning that they were violating the Federal Food, Drug and Cosmetic Acts.
This was the third time in recent years that the FDA has issued warnings to CBD manufacturers and retailers, which market hemp-derived CBD products as nutraceuticals or food supplements. The most recent round of FDA warning letters did not involve false statements about the source of the CBD extracts. Instead, the agency objected to unsubstantiated medical claims allegedly made by four CBD oil producers: Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and last but not least, the Stanley Brothers.
Some of these unsubstantiated claims, according to the FDA, included patient testimonials and assertions that CBD “may be effective in treating tumors from cancer” and other diseases. Thus far, however, there have been no FDA-approved clinical trials that might validate preclinical studies and anecdotal accounts of CBD’s anti-cancer properties.
Today one can easily purchase unregulated CBD products online and at some supermarkets and storefronts across the nation. For the most part, it’s a crapshoot for consumers: A new study published in the Journal of the American Medical Association disclosed that only 31 percent of 84 lab tested hemp-derived CBD products contained the amount of CBD indicated on the label. And who knows what else was in some of these products.
While CBD currently seems to be a low priority for federal law enforcement agencies, in recent months there have been sporadic local police raids against CBD retailers in several states besides North Dakota, including (but not limited to):
- Indiana. In April 2017, Governor Eric Holcomb signed a bill allowing people with treatment-resistant epilepsy who register with the state to possess CBD products that contain less than 0.3 percent THC. Shortly thereafter, a law enforcement crackdown on CBD retailers resulted in the seizure of more than 3000 CBD products from about 60 stores throughout the Hoosier State. In August, Indiana’s Alcohol and Tobacco Commission declared a moratorium on CBD raids “unless the products clearly violate Indiana law.” Since the moratorium announcement, Indiana excise police have continued to issue citations to stores selling CBD.
- Missouri. Vince Sanders, owner of American Shaman, a Kansas City-based wholesaler, supplied CBD products to several stores in Missouri and Kansas. He says his products are legal because they are made from industrial hemp and contain hardly any THC. But Missouri law only allows for low-THC cannabis oil to be sold by manufacturers that are licensed by the state health department, which is not the case for American Shaman.
- Kansas. Kansas is a zero tolerance state when it comes to THC – hardly any is too much in Kansas. Eddie Smith, owner of Into The Mystic, was surprised when police officers showed up at his alternative medicine store in Mission, Kansas, in May 2017 and confiscated an array of hemp-derived CBD products. During a previous visit, an undercover cop purchased some CBD from Smith’s store. A 22-year-old U.S. Army veteran, Smith protested that he had been told “with 100 percent certainty that [CBD] is totally legal in all 50 states.”
- Wisconsin. In May 2017, police raided several gas stations in Oshkosh, Wisconsin, which sold CBD products. A month later, police busted two storefronts in Franklin, Wisconsin, for retailing CBD-infused gummies that contained traces of THC. The store owners said that they had been assured by the wholesale CBD vendor that the products were legal to sell and possess. But Wisconsin law stipulates that CBD can only be dispensed by a pharmacist or physician – not a gas station – to a patient who has been certified to possess cannabidiol for treating a specific medical condition.
- Ohio. In August 2017, police returned 18 bottles of hemp-derived CBD to Poor Boys Smoke Shop in Marysville, Ohio, after a Union County prosecutor declined to press charges stemming from a law enforcement raid two years earlier. Medical marijuana is technically legal in Ohio, but corrupt licensing procedures have stymied patient access to cannabis and CBD-rich products.
- Nebraska. In September 2017, Nebraska Attorney General Doug Peterson declared that CBD sales in the Cornhusker State are flat-out illegal. But under state law, the University of Nebraska Medical Center has the authority to distribute CBD to certified patients who participate in an experimental research program. CBD commerce outside of the university program is strictly forbidden. “To date no drug products containing CBD have received FDA approval,” Peterson noted.
- Massachusetts. Two detectives visited Jay’s Smoke Shop in Taunton, MA, to inform the proprietor that it was not okay to sell CBD products at his store, even though residents in the Bay State had voted to legalize cannabis both for medical and adult use. It’s currently legal to possess and use cannabis, including CBD-rich products, in Massachusetts, but not in public or while driving a vehicle. Storefront sales won’t be authorized until 2018 at the earliest.
Currently eight states plus the District of Columbia have legalized cannabis for both medical and adult use; twenty-one more states allow the therapeutic use of cannabis to some degree, but not recreational use; and 18 states have legalized CBD, but not the whole plant or cannabis products containing higher levels of THC. Only three states consider every part of the cannabis plant, including CBD, to be illegal.
Does this mean that cannabidiol is actually legal in most of the United States?
Yes, sort of … maybe.
Confusion regarding CBD’s status stems in part from the patchwork of complicated laws that vary from state to state. But the main problem is Uncle Sam’s abject refusal to acknowledge what has been known throughout the world for centuries: cannabis has significant medical value. Cannabis prohibition, a draconian, racist relic, is based on a mountain of lies, and until this anachronistic policy is terminated, attempts to sort out the legal status of CBD will be mired in contradiction and uncertainty.
Most so-called CBD-only states allow possession of very low or no-THC cannabis products, but do not allow licensed dispensaries, production facilities or home cultivation. In other words, one can possess CBD, but one can’t legally buy it or sell it. Overly restrictive laws in CBD-only states often limit the use of CBD products to children with treatment-resistant seizure disorders.
But even in states with legal protections for CBD users, the substance is still technically forbidden under federal law. Several bills are pending in Congress to extricate CBD from the Controlled Substances Act. Such efforts would not be necessary if CBD was federally legal.
No resin, no THC, no CBD
Undaunted, some CBD proponents believe that cannabidiol is already legal by virtue of a 2004 Ninth Circuit U.S. Appeals Court decision (Hemp Industries Association v. DEA) that struck down the DEA’s attempt to ban hemp food products. But this decision never mentioned CBD and the reasoning behind it undermines the notion that hemp stalk is a viable source of CBD.
The Ninth Circuit rejected the DEA’s argument because hemp food products aren’t made from the resin-bearing parts of the plant – the flower tops and leaves – that contain THC and other proscribed cannabinoids.
Hemp-derived protein powder and nutritional supplements are made from hempseed, which has no resin, no THC and no CBD; thus hemp food, according to the Ninth Circuit ruling, is exempt from the Controlled Substances Act.
The DEA lacked credibility when it argued that hemp food should be banned because it comes from hempseed (which is resin-deficient). And today’s CBD hemp companies lack credibility when they try to skirt the law by arguing that their CBD comes from hemp stalk (which is resin-deficient).
The Farm Bill exception
The 2014 Farm Bill also makes no mention of CBD, but it is often cited by domestic hemp producers as the reason why CBD is federally legal. The Farm Bill defines industrial hemp as cannabis that contains 0.3 percent THC or less. Cannabis with more than 0.3 percent THC in any part of the plant is considered marijuana and is therefore illegal under federal law.
Most significantly, the Farm Bill carved out an exception to the Controlled Substances Act for industrial hemp that is cultivated under the auspices of a state-sanctioned agricultural or academic research program. (The Farm Bill doesn’t specify what constitutes “research.”) Thus far, twenty-three states have enacted laws pertaining to industrial hemp. And for the first time since World War II, industrial hemp is being grown – supposedly for research purposes –in many parts of the United States.
The Omnibus Appropriations Act of 2016 gave another boost to the fledgling domestic hemp industry by stipulating that federal funds could not be used “to prohibit the transportation, processing, sale or use of industrial hemp that is grown or cultivated in accordance with [the Farm Bill]” – in other words, neither the DEA nor state law enforcement can prevent interstate commerce involving industrial hemp.
Does this mean that CBD oil extracted from hemp grown in Kentucky or Colorado is legal to process, sell and transport across state lines, as long as it doesn’t have more than 0.3 percent THC?
The Hemp Industries Association says yes. The DEA says no.
Legal battle looming
In December 2016, the DEA issued an administrative tracking code for cannabis oil extracts, including CBD concentrates and isolates derived from hemp biomass as well as from marijuana leaves and flower tops. This tracking code did not ban CBD because CBD has always been illegal under the 1970 Controlled Substances Act, which forbids any preparation made from cannabis resin. All the phytocannabinoids, including CBD and THC, reside in the resinous trichomes of the cannabis plant.
The Hemp Industries Association (HIA) maintains that the DEA failed to recognize the legal distinction between marijuana and hemp, as defined by the Farm Bill, when it announced the new tracking code for cannabis oil extracts. So in January 2017, the HIA filed a judicial review petition that challenged the DEA’s churlish administrative maneuver.
Until a federal judge weighs in, robust CBD commerce will continue in a confusing legal environment, while sports stars and celebrities sing the praises of CBD and medical patients clamor for quality cannabis oil extracts.
About the Author:
Martin A. Lee is the director of Project CBD and author of Smoke Signals: A Social History of Marijuana – Medical, Recreational and Scientific.
1 Even though 0.3 percent THC is an arbitrary political number with no scientific basis, it has become the current standard that much of the world uses to distinguish hemp from marijuana. The 0.3 percent legal limit for THC is based on the work of Canadian cannabis researcher Ernst Small, who wrote The Species Problem with Cannabis. In this book, Small acknowledged that there isn’t a natural dividing point at which cannabinoid content could be used to distinguish hemp from other kinds of cannabis. Nevertheless, he chose 0.3 percent THC as where to draw the line on the continuum of cannabis types.
2 The 1970 Controlled Substances Act defines “marihuana” as “all parts of the plant Cannabis sativa L. [sic], whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil or cake, or the sterilized seed of such plant which is incapable of germination.”
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