Category Archives: FDA

FDA News Release FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

For Immediate Release

November 1, 2017

Release

As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.

“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,” said FDA Commissioner Scott Gottlieb, M.D. “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.”

The FDA issued warning letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC – citing unsubstantiated claims related to more than 25 different products spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded claims about their products’ ability to limit, treat or cure cancer and other serious diseases. Examples of claims made by these companies include:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

Unlike drugs approved by the FDA, the manufacture of these products has not been subject to FDA review as part of the drug approval process and there has been no FDA evaluation of whether they work, what the proper dosage is, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns. The FDA has requested responses from the companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.

“We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market,” Commissioner Gottlieb added. “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”

This latest action builds on the more than 90 warning letters issued in the past 10 years, including more than a dozen this year, to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Additionally, the FDA recently took decisive action to prevent the use of a potentially dangerous and unproven treatment used in ‘stem cell’ centers targeting vulnerable cancer patients. The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

###

SOURCE LINK / CONTINUE READING…

Advertisements

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.

###

SOURCE

 

RELATED:

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

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.

CONTINUE READING…