Category Archives: FDA

FDA News Release: Kratom seized in California by US Marshals Service

Mitragyna_speciosa111

 

For Immediate Release

August 4, 2016

Release

The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.

The U.S. Department of Justice filed the complaint, on behalf of the FDA, in the U.S. District Court for the Central District of California, alleging that the seized kratom products are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

“The FDA will continue to take aggressive enforcement action to safeguard the public from harmful drug products illegally marketed as treatments for which they have not been studied or approved,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs.

The FDA is warning consumers not to use any products labeled as containing the botanical substance kratom. Mitragyna speciosa, commonly known as kratom, grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts including, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.

In January 2016, the FDA inspected the Grover Beach facility and also found that Nature Therapeutics’ website and social media sites included claims establishing that the company’s Kratom Therapy products are drugs because they are intended for use in the cure, mitigation, or treatment of various diseases. The FDA has not approved Nature Therapeutics’ products for any use. In addition, the complaint alleged that Nature Therapeutics’ products are also misbranded drugs because their labeling fails to provide adequate directions for use. The California Department of Public Health embargoed the products on behalf of the FDA.

In February 2014, the FDA issued an import alert regarding imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination.

Health care professionals and consumers should report any adverse events related to products containing kratom to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE

 

RELATED:

The DEA has filed notice of intent to add Kratom to schedule 1

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THE PROTECTION OF COMMERCE IN THE FORM OF PHARMACEUTICAL INDUSTRIAL COMPLEX

 

 

 

 

 

 

http://www.cms.gov/medicare-cover…/…/icd-9-code-lookup.aspx…&

ICD-9 Code Lookup

Find an ICD-9 Code by searching on keyword(s).

ICD-9 Code ICD-9 Code Description
304.30 CANNABIS DEPENDENCE UNSPECIFIED USE
304.31 CANNABIS DEPENDENCE CONTINUOUS USE
304.32 CANNABIS DEPENDENCE EPISODIC USE
304.33 CANNABIS DEPENDENCE IN REMISSION
305.20 NONDEPENDENT CANNABIS ABUSE UNSPECIFIED USE
305.21 NONDEPENDENT CANNABIS ABUSE CONTINUOUS USE
305.22 NONDEPENDENT CANNABIS ABUSE EPISODIC USE
305.23 NONDEPENDENT CANNABIS ABUSE IN REMISSI

This is what the FDA and DEA have for us. Instead of repealing the laws on “Cannabis” and “Cannabis Abuse” They have CODES to charge your insurance company for and 3 Million Dollars to PHARMA to come up with a new DRUG (cleared by the FDA of course) to COMBAT MARIJUANA ADDICTION — This is nonsense at its best!

THE PROTECTION OF COMMERCE IN THE FORM OF PHARMACEUTICAL INDUSTRIAL COMPLEX AND THEY WILL SELL IT TO YOU AS IF THEY ARE “HELPING YOU” COMBAT ADDICTION.

It will additionally be mandated that those brought into the welfare or child protective services or psychiatric medical care be forced to succumb to the use of this drug (not unlike what is being done now with anti-depressants and other “mental” drugs).  If it isn’t stopped in its tracks now this is your future!

Everyone already knows (or should know) that MMJ itself helps to combat addiction to most everything…. GW PHARMA has already concluded in their advertisment that Cannabis (Sativex) is NOT ADDICTING…. So why are they doing all of this??? To protect commerce and convince you that they are only helping you. What a crock of shit….

sk.

 

 

Marijuana food safety new frontier for officials

By Kristen Wyatt   | Associated Press   June 21, 2014

DENVER — The marijuana in those pot brownies isn’t the only thing that can potentially make consumers sick. The industry and regulators are taking a closer look at how marijuana-infused edibles are made.

The thriving edible marijuana industry in Colorado is preparing for new testing requirements — due to take in effect in October — to make sure the products are safe to eat and drink.

While consuming too much of an edible has been connected to at least one death and a handful of hospital visits since retail recreational sales of marijuana began in January, officials say there have been no reports of anyone getting a food-borne illness from edibles.

Still, activists, producers, and officials agree that safety testing is long overdue for a sector of the new marijuana market that, according to one industry estimate, has seen the sale of at least 8 million pieces this year.

Food safety testing is necessary ‘‘to building any sort of credibility for the industry . . . to create that public confidence that we’re not just a bunch of stupid kids throwing marijuana into cookies and putting them on the market,’’ said Jazzmine Hall-Oldham, general manager of Bakked, which makes cannabis concentrates and marijuana-infused chocolate bars.

With federal help in regulating production nonexistent because the drug is illegal under federal law, state and local governments have had to assemble a patchwork of health and safety regulations for foods with cannabis.

The agency that regulates Colorado’s marijuana industry, the state Department of Revenue, requires marijuana manufacturing facilities to meet the same sanitation requirements as retail food establishments, including adequate hand-washing and refrigeration.

But the question of whether the state’s 51 licensed recreational edible-marijuana makers meet those standards is left to local health departments, said agency spokeswoman Natriece Bryant. State regulations requiring them also to pass tests for common food contaminants — such as E. coli and salmonella — don’t take effect until the fall.

In Washington state, where retail sales are expected to begin the week of July 7, regulations call for samples of all marijuana sold for consumption to clear a ‘‘microbiological screening,’’ whether it’s in edible, smokeable, or concentrate form.

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