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FDA Rejects Petition To Further Restrict Marijuana

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The U.S. Food and Drug Administration (FDA) has denied a request from an anti-legalization group to place marijuana and its derivatives on a list of restricted substances that are not “generally recognized as safe and effective.”

The move is “not necessary for the protection of public health,” Janet Woodcock, the director of FDA’s Center for Drug Evaluation and research wrote on Monday in a letter to the group, Drug Watch International.

The organization had filed its petition requesting the cannabis crackdown in December, writing that the move would “send an industry-wide warning to the estimated 33,000 marijuana businesses in the U.S., many of which are making unsupported medical claims for marijuana and THC drug products sold as ‘medical marijuana.'”

The prohibitionist organization pleaded with FDA to take action that would “reduce or end the ability of [over-the-counter] sellers of these drugs to assert and advertise unsupported medical claims for their products.”

“It would immediately make such claims unlawful and subject the sponsors to regulatory action, including injunctive seizure of mislabeled and misbranded drugs, as well as other potential sanctions permitted under the [Food, Drug and Cosmetic Act].”

But FDA balked, saying that while it “appreciates the safety and public health concerns that motivate” the request, the agency “already has adequate authority to remove unapproved new OTC drugs containing marijuana or THC from the market.”

“In order for FDA to take enforcement action against illegal marketing of unapproved new OTC drugs containing marijuana or THC, it is not necessary for FDA to establish a negative monograph for marijuana or THC.”

While the decision by FDA not to assign so-called “negative monograph” status to marijuana and THC won’t do anything to make marijuana more available, or change its legal status—which remains prohibited under Schedule I of the Controlled Substances Act—the rejection suggests that the Trump administration is not looking for excuses to go out of its way to deal public relations blows to the cannabis industry.

In fact, despite a move by U.S Attorney General Jeff Sessions this January to rescind Obama-era protections for state marijuana laws, President Trump himself indicated last month that he supports pending congressional legislation to end federal cannabis prohibition.

Last week, the powerful U.S. Senate Appropriations Committee issued a report criticizing roadblocks to research on marijuana that are caused by its ongoing Schedule I status.

The FDA’s negative monograph list currently contains unapproved drug products such as certain daytime sedatives, aphrodisiacs and deterrents to nailbiting or thumbsucking.

The list is “not intended to be comprehensive lists of all classes of OTC products, active ingredients, or conditions of use that cannot be marketed without FDA approval,” the agency wrote in its rejection of the Drug Watch International petition.

“While you suggest that a negative monograph would reduce or end the unlawful marketing of unapproved new OTC drugs containing marijuana or THC, existing law makes very clear that such unapproved products cannot be marketed under the FD&C Act,” the feds said. “FDA has not determined that any OTC drug products containing marijuana or THC are [generally recognized as safe and effective]  for their intended indications. Therefore, these products are ‘new drugs’ per section 201 of the FD&C Act that must be approved by FDA to be legally marketed.”

“That the Agency has not promulgated a negative monograph specific to marijuana or THC does not absolve a drug manufacturer or marketer from its responsibility to obtain an approved NDA or ANDA if one is required by law.”

“It is the responsibility of companies marketing drug products in the United States to ensure that their products are safe and effective and marketed in compliance with the law,” FDA’s Woodcock wrote. “[A]s discussed above, FDA has existing authority to pursue regulatory or enforcement actions regarding unapproved new OTC drugs, including those containing THC or marijuana.”

Indeed, FDA sent a series of warning letters in November to manufacturers of products containing cannabidiol (CBD), a marijuana component that is increasingly used to treat epilepsy and other medical conditions, and which is sometimes marketed as having tumor-shrinking properties.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” FDA Commissioner Scott Gottlieb said in a press release at the time. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

More recently, however, FDA approved a CBD pharmaceutical drug, Epidiolex, to treat severe epilepsy.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” Gottlieb said in the press release announcing the move last month. “But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

For now, that Gottlieb’s FDA passed up the opportunity to add marijuana to the restrictive negative monograph list allows the cannabis industry to avoid another round of headlines about finger-wagging federal regulators calling them out.

This piece was first published by Forbes.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Tom Angell is the editor of Marijuana Moment. A 15-year veteran in the cannabis law reform movement, he covers the policy and politics of marijuana. Separately, he founded the nonprofit Marijuana Majority. Previously he reported for Marijuana.com and MassRoots, and handled media relations and campaigns for Law Enforcement Against Prohibition and Students for Sensible Drug Policy. (Organization citations are for identification only and do not constitute an endorsement or partnership.)

Culture

Lots Of Politicians And Companies Are Tweeting About Marijuana On 4/20

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It’s 4/20 again, and that means another slew of tweets from politicians and mainstream brands looking to use the marijuana holiday as a hook to get their message out.

Here’s a roundup of some of the best, funniest, most important or otherwise notable cannabis-related tweets of the day…

Sen. Cory Booker (D-NJ), a presidential candidate:

Sen. Bernie Sanders (I-VT), a presidential candidate:

Sen. Kamala Harris (D-CA), a presidential candidate:

Sen. Kirsten Gillibrand (D-NY), a presidential candidate:

Rep. Tulsi Gabbard (D-HI), a presidential candidate:

Rep. Eric Swalwell (D-CA), a presidential candidate:

Former Rep. Beto O’Rourke (D-TX), a presidential candidate:

Former Sen. Mike Gravel (D-AK), a presidential candidate:

Washington State Gov. Jay Inslee (D), a presidential candidate:

Former San Antonio, Texas Mayor Julián Castro (D), a presidential candidate:

Democratic presidential candidate Andrew Yang:

Senate Minority Leader Chuck Schumer (D-NY):

House Committee on Small Business:

Congressional Black Caucus:

Sen. Jacky Rosen (D-NV):

Rep. Earl Blumenauer (D-OR):

Rep. Ilhan Omar (D-MN):

Rep. Barbara Lee (D-CA):

Rep. Ro Khanna (D-CA):

Rep. Charlie Crist (D-FL):

Rep. Steve Cohen (D-TN):

Rep. Deb Haaland (D-NM):

Pennsylvania Lt. Gov. John Fetterman (D):

Los Angeles, California City Council President Herb Wesson (D):

Cook County, Illinois State’s Attorney Kim Foxx (D):

The American Civil Liberties Union:

Ben & Jerry’s:

Denny’s:

Hidden Valley Ranch:

Carl’s Jr.:

Boston Market:

George Washington’s Mount Vernon:

Bill Maher:

Miley Cyrus:

311:

The Onion:

Ben & Jerry’s Stands Out From Companies Just Trying To Make Money From 4/20

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State-Legal Marijuana Use Makes Immigrants Morally Unfit for Citizenship, Trump Administration Warns

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A federal immigration agency clarified on Friday that using marijuana or engaging in cannabis-related “activities” such as working for a dispensary—even in states where it’s legal—is an immoral offense that makes immigrants ineligible for citizenship.

When applying for naturalization, the process of gaining citizenship, individuals must have established “good moral character” in the five years preceding the application. Good moral character is a vague requirement that has been criticized by scholars and civil rights advocates, as assessing morality is arguably subjective.

According to the U.S. Citizenship and Immigration Services (USCIS), state-legal marijuana consumption renders individuals morally unfit for citizenship. The new policy clarification reflects a sentiment once expressed by former Attorney General Jeff Sessions, who said that “good people don’t smoke marijuana.”

The USCIS memo says that “violation of federal controlled substance law, including for marijuana, established by a conviction or admission, is generally a bar to establishing [good moral character] for naturalization even where the conduct would not be a violation of state law.”

Further, an applicant “who is involved in certain marijuana related activities may lack GMC if found to have violated federal law, even if such activity is not unlawful under applicable state or foreign laws,” the document says. The policy also applies to individuals who worked in the state-legal cannabis industry.

There have already been reports of people being denied citizenship due to their proximity to state-legal marijuana businesses. Earlier this month, Denver Mayor Michael Hancock hosted a group of immigrants who said their work in the state’s cannabis industry was being used as justification by federal officials to deny them citizenship.

“In Colorado, cannabis has been legal for 5 years. For work in a legal industry to be used against an individual trying to gain citizenship is a prime example of why we need to harmonize our state and federal laws to ensure that states like Colorado that have moved to legalize cannabis can act in our own authority to expand and regulate our cannabis industry,” Rep. Joe Neguse (D-CO), told Marijuana Moment in reaction to the Trump administration memo.

Legalization activists also criticized the move.

“The cruel treatment of immigrants for offenses related to something as minor as marijuana is illustrative of the way this administration has used the war on drugs to pursue communities of color,” Michael Collins, director of national affairs at the Drug Policy Alliance, told Marijuana Moment. “It also shows that pursuing a state by state approach to federal policy doesn’t work for these communities. Federal descheduling is essential.”

While the federal policy deeming marijuana use a violation of “good moral character” standards for immigration purposes was already on the books, it seems the spread of state-level cannabis legalization has prompted the agency, which is part of the Department of Homeland Security, to issue the clarification.

“A number of states and the District of Columbia (D.C.) have enacted laws permitting ‘medical’ or ‘recreational’ use of marijuana. Marijuana, however, remains classified as a ‘Schedule I’ controlled substance under the federal CSA,” the updated USCIS policy manual now reads. “Schedule I substances have no accepted medical use pursuant to the CSA. Classification of marijuana as a Schedule I controlled substance under federal law means that certain conduct involving marijuana, which is in violation of the CSA, continues to constitute a conditional bar to GMC for naturalization eligibility, even where such activity is not a criminal offense under state law.”

“Such an offense under federal law may include, but is not limited to, possession, manufacture or production, or distribution or dispensing of marijuana. For example, possession of marijuana for recreational or medical purposes or employment in the marijuana industry may constitute conduct that violates federal controlled substance laws. Depending on the specific facts of the case, these activities, whether established by a conviction or an admission by the applicant, may preclude a finding of GMC for the applicant during the statutory period. An admission must meet the long held requirements for a valid ‘admission’ of an offense. Note that even if an applicant does not have a conviction or make a valid admission to a marijuana-related offense, he or she may be unable to meet the burden of proof to show that he or she has not committed such an offense.”

The underlying policy does provide an exception for “a single offense of simple possession of 30 grams or less of marijuana.”

An additional update to the policy manual stipulates that the exception “is also applicable to paraphernalia offenses involving controlled substances as long as the paraphernalia offense is ‘related to’ simple possession of 30 grams or less of marijuana.”

That detail wasn’t included in an earlier 2014 version of the USCIS policy manual.

The policy alert is similar to an update the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) issued in 2017 when the federal gun purchase application form was revised to include a warning that the “use or possession of marijuana remains unlawful under Federal law regardless of whether it has been legalized or decriminalized for medicinal or recreational purposes in the state where you reside” and therefore disqualifies applicants.

But the USCIS clarification also reflects a recent ratcheting up of anti-immigration policy moves under the Trump administration.

Jason Ortiz, vice president of the Minority Cannabis Business Association, told Marijuana Moment that the new memo reflects a “callous and irrational decision” by the administration and “is a reminder that without comprehensive cannabis reform our communities of color will continue to be prosecuted and subject to deportation for activity that is legal for affluent communities around the country.”

“Proposals such as the STATES act which seek to simply ease the risk on business do not address these deeper issues related to federal prohibition,” he said. “Considering the devastating effects our war on drugs had on Latin America, immigration reform must be a necessary component of any comprehensive cannabis legalization policy.”

People Could Use Marijuana In Public Housing Under New Congressional Bill

This story has been updated to include comment from Neguse.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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USDA Clarifies That Farmers Can Import Hemp Seeds From Other Countries

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The U.S. Department of Agriculture (USDA) clarified on Friday that hemp seeds can be imported into the U.S., and that the Justice Department no longer has a role in that process.

While USDA is still developing regulations for hemp cultivation under the 2018 Farm Bill, which federally legalized the crop and its derivatives, farmers can still obtain seeds in the meantime.

The agriculture legislation “removed hemp and hemp seeds from DEA authority for products containing THC levels not greater than 0.3 percent” and “DEA no longer has authority to require hemp seed permits for import purposes.”

“U.S. producers and hemp seed exporters have requested assistance from USDA to provide an avenue for hemp seed exports to the United States,” the department wrote in a bulletin. “The U.S. Department of Agriculture regulates the importation of all seeds for planting to ensure safe agricultural trade. Under this authority, USDA is providing an alternative way for the safe importation of hemp seeds into the United States.”

Sen. Jon Tester (D-MT) is among those who’ve requested assistance related to hemp importations. Earlier this month, he told Agriculture Secretary Sonny Perdue that the DEA was blocking Montana farmers from importing hemp seeds.

Perdue said during the hearing that the matter was “news to me” and explained that farmers can import and cultivate hemp under the research-focused provisions in the prior 2014 version of the legislation while the USDA worked to enact new regulations.

In a letter sent to the acting administrator of Customs and Border Protect (CBP) on Tuesday, Tester and Sen. Patrick Leahy (D-VT) raised the concern again, imploring CBP to update its policy to reflect that hemp seeds can be lawfully imported. The letter was obtained by the industry advocacy group Vote Hemp.

The USDA bulletin specified how the process works for imports from Canada and other countries.

Importation of Hemp Seed from Canada

“Hemp seeds can be imported into the United States from Canada if accompanied by either: 1) a phytosanitary certification from Canada’s national plant protection organization to verify the origin of the seed and confirm that no plant pests are detected; or 2) a Federal Seed Analysis Certificate (SAC, PPQ Form 925) for hemp seeds grown in Canada.”

Importation of Hemp Seed from Countries other than Canada

“Hemp seeds may be imported into the United States from countries other than Canada if accompanied by a phytosanitary certificate from the exporting country’s national plant protection organization to verify the origin of the seed and confirm that no plant pests are detected.

Hemp seed shipments may be inspected upon arrival at the first port of entry by Customs and Border Protection (CBP) to ensure USDA regulations are met, including certification and freedom from plant pests.”

The rulemaking process for hemp may take some time, as Perdue said the department would not expedite the regulations and will be “taking this slow.” Once the USDA has a regulatory framework in place, it will begin approving state plans, and those states will be the primary regulators.

For the time being, however, there’s nothing stopping farmers from collecting certified hemp seeds. Not even the DEA.

Trump Agriculture Secretary Accepts Invitation To Tour Hemp Farms

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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