Tagged: FDA Toggle Comment Threads | Keyboard Shortcuts

  • ShereeKrider 12:16 am on June 14, 2017 Permalink | Reply
    Tags: Analogues, , , FDA, HR 2851, , , , S. 1327, Schedule A, Sen. Chuck Grassley, Sen. Dianne Feinstein, SITSA ACT   

    SITSA creates a new “Schedule A” that gives the Attorney General of the United States the power to ban any “analogue” of an opioid that controls pain or provides an increase of energy. 


    Image may contain: 1 person, plant, nature and outdoor

    Kratom Advocates:

    If you’ve had one of those days that starts with friends calling you with bad news, and the news just gets worse and worse as the day goes on – then that describes my day perfectly.

    On Friday of last week, Sen. Chuck Grassley of Iowa, and Sen. Dianne Feinstein of California, dropped a bill in the U.S. Senate that our lobbyists believe will give the FDA and DEA a backdoor way of banning kratom completely in the United States.

    S. 1327 is euphemistically called the SITSA Act.  And a companion bill in the US House of Representatives has already been filed, H.R. 2851, by Representative John Katco of New York.

    The SITSA Act stands for the “Stop Importation and Trafficking of Synthetic Analogues Act of 2017.”
    SITSA creates a new “Schedule A” that gives the Attorney General of the United States the power to ban any “analogue” of an opioid that controls pain or provides an increase of energy.

    That is kratom. Because kratom’s 2 primary alkaloids, mitragynine and 7-hydroxymitragynine, though not opioids, act similarly in some ways.
    They could of just called this bill the “Schedule Kratom” Act.

    This legislation will allow the Attorney General, and his supporters at the DEA, to add kratom to Schedule A on a “temporary basis” that will last for 5 years.
    And once added to Schedule A, the Attorney General can convert it to a permanent schedule.
    After everything that we’ve fought successfully against and endured together as a movement, our lobbyists are concerned that this is now the perfect storm for banning kratom.

    Under the current Controlled Substances Act, the FDA and DEA have to prove conclusively that kratom is dangerously addictive and unsafe for consumer use. That’s why we were able to stop them in their tracks when they tried to ram through an “emergency scheduling” ban on kratom.

    And it is why the FDA is having such a tough time in finding some justification to schedule kratom under regular rulemaking.

    So now the anti-kratom bureaucrats in Washington want to ban kratom simply by claiming it has the same effects as an opioid – calling it an “analogue” of the opioid.

    And the SITSA Act can enforce a ban on kratom by criminalizing any manufacturer or distributor of kratom. Ten years imprisonment just for manufacturing or selling a kratom product, and a fine of $500,000 if you are an individual, $2,500,000 if the defendant is a company.

    If you import or export kratom, it is a 20-year sentence.

    And then there are harsh penalties for what they call “false labeling” of a Schedule A substance.
    That’s why am writing – because I need your help again.

    We have to convince Sen. Grassley, Sen. Feinstein, and Representative Katko that they have to exempt natural botanical plants from the SITSA Act.
    We have to act quickly, because I learned today that the House Judiciary Committee is looking to schedule a Hearing before they leave for recess next month.

    So I hope you will help by doing three specific things:

    1.    Click on the link below and sign our petition that the AKA will have delivered to every member of the Senate and House Judiciary Committees. 

    PLEASE SIGN THIS PETITION URGING LAWMAKERS TO REMOVE KRATOM FROM THE SITSA ACT.

    2.    I need you to pick up the phone and call Sen. Grassley’s office, Sen. Feinstein’s office, and Representative Katco’s office. When the staff member answers the phone, tell them that their boss should exclude natural botanicals like kratom products from the SITSA Act.

    Here are the phone numbers you should call:

    Senator Grassley:    (202) 224-3744
    Senator Feinstein:    (202) 224-3841
    Congressman Katco:    (202) 225-3701

    When you call, be polite, but firm.  Kratom should be exempted from SITSA.

    3.    Please click on the donation link below and help us once again to take on this fight with a team of lawyers, lobbyists, and public relations professionals.  Please consider making a monthly contribution to the AKA.

    DONATION LINK TO HELP THE AKA FIGHT THIS LEGISLATION.

    I know I am asking a lot.

    But we need to fight back hard, or they will steal our freedoms from us to make our own decisions about our health and well-being.

    So please, sign the petition, call the the sponsors of SITSA, and please, please, give as generous a contribution as you can to help us put our team on the ground in Washington, D.C.

    With your help, we have established ourselves as a real force in Washington.

    With your continued help – help that I am so grateful for – we can win this battle against the enemies of kratom.

    Your contribution will help us hire the lawyers we need for a brief on why this legislation violates due process and current law; our lobbyists to knock on doors on Capitol Hill; and our public relations team to rally the press to tell our story.

    We will stand up for freedom.

    Thank you for your continued support.

    Sincerely,

    Susan Ash
    Founder and Spokesperson
    American Kratom Association
    http://www.americankratom.org

    http://mailchi.mp/americankratom/new-legislative-attack-on-kratom?e=2709219685

    https://www.facebook.com/kratom.us/photos/rpp.260289027341069/873568049346494/?type=3&theater

     
  • ShereeKrider 6:48 pm on October 12, 2016 Permalink | Reply
    Tags: , FDA, , ,   

    The DEA is withdrawing a proposal to ban another plant after the Internet got really mad 


    By Christopher Ingraham October 12 at 10:42 AM

    The Drug Enforcement Administration is reversing a widely criticized decision that would have banned the use of kratom, a plant that researchers say could help mitigate the effects of the opioid epidemic.

    Citing the public outcry and a need to obtain more research, the DEA is withdrawing its notice of intent to ban the drug, according to a preliminary document that will be posted to the Federal Register Thursday.

    The move is “shocking,” according to John Hudak, who studies drug policy at the Brookings Institution. “The DEA is not one to second-guess itself, no matter what the facts are.”

    The DEA had announced in August that it planned to place kratom in schedule 1 of the Controlled Substances Act, the most restrictive regulatory category, as soon as Sept. 30. But since announcing their intent to ban kratom, the “DEA has received numerous comments from members of the public challenging the scheduling action,” acting administrator Chuck Rosenberg wrote in the notice, “and requesting that the agency consider those comments and accompanying information before taking further action.”

    A spokesman for the Drug Enforcement Administration did not immediately respond to requests for comment.

    [What it’s like to be high on kratom, according to the people who use it]

    Kratom is a plant from southeast Asia that’s related to coffee. It contains a number of chemical compounds that produce effects similar to opiates when ingested.

    People who take it have have said kratom helped them overcome addiction to opiates or alcohol and treat otherwise intractable pain. Researchers say that their work with kratom could eventually lead to the development of nonaddictive alternatives to powerful opiate painkillers. Placing kratom in schedule 1 would cripple researchers ability to study the drug, they say.

    U.S. lawmakers were among the groups expressing their displeasure with the DEA’s intent to ban kratom. A group of 51 U.S. representatives wrote to the DEA saying that the DEA’s move “threatens the transparency of the scheduling process and its responsiveness to the input of both citizens and the scientific community.”

    Another group of nine senators said the DEA’s “use of this emergency authority for a natural substance is unprecedented,” and urged the administration to reconsider.

    The DEA will now open up a period for public comment until Dec. 1 of this year. It is also asking the FDA to expedite a “scientific and medical evaluation and scheduling recommendation” for the active chemical compounds in kratom.

    At the close of the comment period, a number of things could happen. The DEA could decide to permanently place the plant in a schedule of the Controlled Substances Act, which would require an additional period for lawmakers and the public to weigh in. It could also decide to temporarily schedule kratom, which would not require any additional comment.

    It could also decide to leave kratom unregulated.

    [Police arrest more people for marijuana use than for all violent crimes — combined]

    Advocates for kratom use, who say the plant has helped them treat pain and stop taking more powerful and deadly opiate painkillers said they are elated.

    “I am in tears,” Susan Ash of the American Kratom Association said in an email. “Our voices are being heard, but we still have a long road ahead of us.

    Lawmakers who criticized the initial announcement to ban kratom are also pleased. “Concerned citizens across the country have made it clear, they want the DEA to listen to the science when it comes to the potentially life-saving properties of kratom,” said Mark Pocan (D.-Wis.) in an email.

    Researchers are welcoming the move, but they point out that the future of their work with the plant is an uncertain one.

    “It’s certainly a positive development,” said Andrew Kruegel of Columbia University in an email. Kruegel is one of the researchers working to develop next-generation painkillers based on compounds contained in kratom.

    Kruegel says that the FDA’s evaluation of the drug will carry a lot of weight in the DEA’s decision. But the kind of rigorous, controlled trials that the FDA typically refers to in situations like this simply don’t exist for kratom.

    “Unfortunately, in the United States I don’t think we have a good regulatory framework for handling this situation or taking perhaps more reasonable middle paths” between banning the drug outright or keeping it unregulated, Kruegel says.

    Still, he says, “the FDA is a scientific agency rather than a law enforcement agency, so I am encouraged that they will now be having more serious input on this important policy decision.”

    Marc Swogger, a clinical psychologist at the University of Rochester Medical Center who has published research on kratom use and earlier called the decision to ban the plant “insane,” said in an email that “I’m happy to see this. It is a step in the right direction and a credit to people who have spoken out against scheduling this plant.”

    CONTINUE READING…

     
  • ShereeKrider 9:54 am on September 22, 2016 Permalink | Reply
    Tags: , FDA, , , protesters,   

    Kratom Advocates Sip Tea and Seethe at White House Rally Against DEA Ban 


    One user plans to move to Canada. Another plans to quit. Many more don’t know what to do.

    By Steven Nelson | Staff Writer Sept. 13, 2016, at 6:20 p.m.

    Several protest attendees brought their own bottle of kratom tea Tuesday to the White House. Those who did not were offered a Solo cup.

    Several protest attendees brought their own bottle of kratom tea Tuesday to the White House. Those who did not were offered a Solo cup. Steven Nelson for USN&WR

    Hundreds of passionate protesters gathered Tuesday near the White House to demand that the popular plant product kratom remain legal. It was jointly a business industry conference, a tea party and a desperate consumer lobbying effort — but the clear-eyed crowd appears to have little chance of near-term victory.

    A comprehensive U.S. ban likely will take effect on Sept. 30, just a month after the Drug Enforcement Administration surprised users by saying it would invoke emergency powers to make leaves from the tree grown in Southeast Asia illegal by labeling two main constituents Schedule I substances.

    In the face of long odds and silence from Capitol Hill, the event called by the American Kratom Association sought to pressure officials to reconsider while laying the groundwork for what may become a protracted re-legalization campaign.

    A large jug of brewed kratom sat in the middle of Pennsylvania Avenue, with red Solo cups offered to anyone who wanted some. At least one reporter sipped the brew, which tasted like astringent green tea. Another journalist took a pill offered as a free sample by a businessman.

    Kratom users who attended the rally said it’s wrong for them to lose legal access to what they say is an effective treatment for pain, addiction, depression and other conditions.

    Though many said they were angry, chant-leaders asked the crowd of a couple hundred to stay on message and favored reason over rage, which often is a leading emotion at White House protests staged by marijuana reform advocates who say decades in Schedule I has stalled medical cannabis research amid millions of arrests.

    “I’m usually very quiet but felt the need to come out and speak,” says Veronika Bamford-Conners, a kratom-selling store owner from Sullivan, Maine, where, she says, most of her customers are older than 55.

    “If they don’t have insurance and can’t afford medications, they find a cheaper alternative in kratom,” she says, though some seem to prefer relief from the leaf to painkillers, such as a 73-year-old man who she says called her weeping “because pharmaceuticals were killing him” before.

    Chants at the rally advertised the death toll from accidental overdoses of opioids – more than 28,000 in 2014 alone, including legal painkillers and illegal drugs like heroin – with the low or nonexistent U.S. toll from kratom.

    The DEA says it believes 15 deaths were caused by kratom, though American Kratom Association founder Susan Ash says the group hired a toxicologist who concluded each case could be attributed to other drugs.

    Many kratom users say the plant has helped them abstain from substances they formerly were addicted to, often heroin or prescription painkillers.

    “Kratom saved me, I was a bad heroin addict,” says David Allen, who traveled from Chapel Hill, North Carolina. “It keeps cravings away and helped me not drink. I came because I don’t want to lose my medicine.”

    Allen says that although the DEA – and even some former kratom users – say the drug can lead to dependence, it’s nothing like the grasp of opioids. He says he believe it’s about as abusable as coffee, which comes from a related plant, and that like coffee withdrawal, ending kratom can cause minor headaches.

    Brad Miller, a physics teacher at Spotsylvania High School in Virginia, says he drinks small amounts of kratom tea between three and five times a day to treat arthritis in his knees. He says the effects are “very mild” and “just enough to take the edge off so I can get through my day standing.”

    Miller says prescribed painkillers from his rheumatologist were too strong and that unlike opioids he hasn’t developed an addiction to kratom. He says he went on a weeklong camping trip and – unlike the experiences of some users – felt no withdrawal symptoms.

    “I didn’t have withdrawal symptoms, but I did have arthritis pain,” he says. “I’d be surprised if anyone has experienced strong withdrawal symptoms.”

    Though Miller and others at the event said they aren’t sure what they will do at the end of the month, Heather Hawkins says she’s made up her mind to move to Canada, where kratom remains legal.

    Hawkins, a journalist with northern Florida’s Pensacola News-Journal and owner of the Kratom Literacy Project, says she has an incurable bladder disease and is eyeing Vancouver after already moved to the Sunshine State from Alabama in reaction to a local kratom ban.

    Talk about moving abroad often is spouted unseriously by political partisans around election time, but Hawkins says she’s completely serious after living in a painkiller-induced haze that left her depressed and unable to get out of bed.

    “I’m not going to stay here [if the ban takes effect] because I’m not going back to that life,” she says.

    Hawkins says she’s in addiction recovery from cocaine, which she says she used as self-medication to give her the energy to power through her pain and despair, and that if she regarded kratom as a drug she would not take it.

    Though kratom is widely known for claims that it can help keep opioid addicts clean, it’s also credited with sapping desire for other substances.

    Jeremy Haley, owner of Colorado’s Rocky Mountain Kratom, says he began using kratom in 2012 after a drunk driving arrest, and that it has helped veer him away from his alcoholism, which runs in the family.

    Although the ban hasn’t yet taken effect, Haley says local officials have shut down his shop for what he views as dubious reasons, making him unable to sell the remaining inventory – the latest in what he says has been a constant regulatory headache that featured him asking Yelp reviewers to delete positive reviews to placate federal officials who wanted proof he was not marketing kratom for human consumption.

    Haley plans to open a totally legal apothecary shop if the ban takes effect.

    CONTINUE READING…


    RELATED CONTENT
    Pot Breathalyzer Hits the Street

    A futuristic drug-detecting fingerprint scanner may soon follow.

     
  • ShereeKrider 1:07 pm on July 10, 2016 Permalink | Reply
    Tags: , , descheduling, FDA, , , Medical Maijuana   

    Is pot as dangerous as heroin? Feds’ decision on rescheduling marijuana coming soon 


    El Monte Police Lt. Christopher Williams looks over a portion of about 500 marijuana plants in various stages of growth after serving a search warrant at a home at 4300-block of Huddart Avenue in El Monte on Monday March 9, 2015.

     

    By Brooke Edwards Staggs, The Orange County Register

    Posted: 07/09/16, 8:37 PM PDT

     

    At the same time Californians are preparing to vote on the legalization of adult marijuana use, the federal government is weighing whether pot should continue to be classified as a top-tier narcotic on par with heroin.

    Within a month, the Drug Enforcement Administration is expected to release a much-anticipated decision that could alter cannabis’ ranking in the hierarchy of controlled substances — a formal listing that affects everything from medical research to taxing policy.

    Since the list was created in 1970, marijuana has been ranked in Schedule I — the most restrictive category ­alongside heroin, LSD and peyote. The designation is reserved for drugs the DEA says have no proven medical use and are highly addictive.

    What about Congress?

    Even if the Drug Enforcement and Food And Drug administrations don’t recommend changing where marijuana falls on the controlled substances list, Congress could.

    Elected officials are more likely to be influenced by growing public acceptance of marijuana — particularly if they represent one of 25 states with legal marijuana programs.

    “I think that’s probably an easier sell than the decision coming from doctors and police,” said John Hudak, a deputy director with the Brookings Institution.

    Some members of Congress support rescheduling marijuana, including Sen. Barbara Boxer. Some have even pitched descheduling it, including presidential hopeful Bernie Sanders. But none of those efforts gained traction, and Paul Armentano with the advocacy group NORML isn’t optimistic Congress will act on the issue anytime soon.

    “I’m not aware of a single hearing much less a vote even in a subcommittee that has ever taken place at the Congressional level specific to the notion of reclassifying marijuana,” he said.

    “We’re bound by the science,” said Melvin Patterson, spokesman for the DEA.

    But many experts and advocates say the current classification is increasingly at odds with scientific studies on marijuana, which suggest the drug has medical value in treating chronic pain, seizures and a number of other conditions, with a lower addiction rate than alcohol.

    The DEA ranking also lags behind a growing public consensus. Roughly 80 percent of Americans believe medical marijuana should be legal, according to recent polls, while some 60 percent support legalizing the drug for all adults.

    “In 2016, this notion that cannabis possesses potential harms equal to that of heroin … simply doesn’t pass the smell test,” said Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws, or NORML.

    Medical marijuana is now legal in 25 states. Recreational use is allowed in four states plus Washington, D.C. If California green-lights recreational use this November, one in six Americans would live in a state where adults would be allowed to freely use cannabis.

    The question of how cannabis should be ranked has been hotly debated since Congress placed it in the Schedule I group when it passed the Controlled Substances Act nearly 46 years ago. The drug’s classification has been reviewed periodically, with the latest reexamination prompted by a petition filed with the DEA five years ago by the then-governors of Rhode Island and Washington.

    In April, the DEA advised Congress that it expected to announce a decision in the first half of 2016.

    Patterson said officials now “clearly anticipate something happening in the next month.”

    The agency has several options: keep cannabis as a Schedule I drug; reclassify some or all of its compounds to a lower schedule; or remove the plant from the controlled substances list altogether.

    There is a greater chance than ever that marijuana will be rescheduled, said John Hudak, who studies the topic as a deputy director with the Brookings Institution. But he still expects pot to remain a Schedule I drug.

    Advertisement

    “It needs to cross a threshold that says it has an accepted medical value,” Hudak said. “While there are plenty of patients and doctors who do believe it has medical value, that’s not a universal belief in the medical community.”

    Leslie Bocskor, president of Las Vegas-based cannabis advisory firm Electrum Partners, thinks the odds slightly favor a reclassification of marijuana to Schedule II. That category includes morphine and cocaine, which the DEA says are highly addictive but have some medical value. A form of cocaine, for example, is used by some dentists as a local anesthetic.

    The least restrictive of the five schedule categories, Schedule V, includes cough syrup with a bit of codeine.

    Alcohol and tobacco aren’t included on the DEA’s controlled substances list, even though federal studies have found both are associated with higher dependency rates than marijuana.

    Patterson said the DEA frequently hears from people frustrated that marijuana hasn’t been rescheduled sooner.

    “They have their mind made up on what marijuana does in the short term,” he said. “But what about different strains? What about 10 years from now or even 20 years from now? Long-term effects matter.”

    For the medical marijuana community, even reclassifying cannabis as a Schedule II drug would offer some vindication.

    “At a minimum, it would bring an end to the federal government’s longstanding intellectual dishonesty that marijuana ‘lacks accepted medical use,’ ” Armentano said.

    Such a shift by the DEA also might offer a small boost to at least half-a-dozen states with medical or recreational marijuana initiatives on the ballot this November.

    That potential to give some credence to legalization efforts is one of the reasons a few members of Congress, including Sen. Chuck Grassley of Iowa, and the organization Smart Approaches to Marijuana, or SAM, cite in arguing against reclassifying marijuana.

    “Rescheduling would simply be a symbolic victory for advocates who want to legalize marijuana,” SAM wrote in a policy paper on the issue.

    But both the California and American medical associations say rescheduling pot could lower the barriers a bit for federally sanctioned drug research.

    The DEA has never turned down a marijuana research request that met federal criteria, Patterson said. But experts say red tape related to Schedule I drug research is so formidable that it discourages applications. So while there are tens of thousands of peer-reviewed studies on marijuana, there are few costly and rigorous double-blind, placebo-controlled trials involving cannabis.

    Moreover, researchers say, marijuana studies are saddled with restrictions that don’t apply to other Schedule I drugs.

    Since 1968, for example, the federal government has said only a tightly controlled stock of high-quality marijuana grown under contract by the University of Mississippi can be used for FDA-approved studies. Armentano said that restricts the supply available for research.

    If marijuana were reclassified to at least Schedule III — alongside Tylenol with codeine and anabolic steroids — it would mean the nation’s rapidly growing number of cannabis-related businesses could begin deducting operating expenses from their federal taxes.

    Under a tax rule imposed during the Reagan Administration’s 1980s anti-drug war, businesses dealing in Schedule I or II substances are prohibited from writing off common expenses such as rent, utilities or advertising.

    Harborside Health Center, a large Oakland dispensary, has been battling the IRS over the rule for five years, after being assessed $2.4 million for illegal deductions. A decision in that case is expected soon.

    Even if cannabis was moved down the controlled substances list to the least-restrictive category, the industry would still be likely to face business and regulatory hurdles.

    Armentano likened such a change, should it come, to the first stride in a marathon.

    “Technically, it gets you closer to the finish line,” he said. “But you still have a whole hell of a long way to go.”

    Pot would remain an illegal substance under federal law. Reclassification wouldn’t necessarily open access to banking services, Hudak said. And doctors wouldn’t automatically switch to writing prescriptions, as opposed to “recommendations,” for medical marijuana, since that’s only allowed for FDA-approved drugs.

    “There are certain people who play up rescheduling as an earth-shattering reform,” Hudak said. “It is not.”

    He said sweeping changes would only come in the unlikely event that cannabis was completely descheduled, putting it on par with alcohol.

    That would allow local governments to create cannabis policies free from federal interference, Armentano said, the way they can set their own hours for when bars stop serving alcohol or make entire counties “dry.”

    Armentano isn’t optimistic the DEA will move marijuana to a less restrictive category, but he said there’s been one positive result from the current review.

    “There’s attention being paid to how they handle this situation in a way that just wasn’t there before,” he said. “If the DEA goes down the same path as it has in the past, I think they’re going to have some explaining to do.”

    CONTINUE READING…

     
  • ShereeKrider 8:06 pm on April 13, 2015 Permalink | Reply
    Tags: doctors, , FDA, , , mandates, , , ,   

    Make the FDA Advisory, Not Mandatory 


    You should control what medicines you use, not the FDA. The FDA should make advisory recommendations only. It should NOT have the power to mandate which drugs you can buy, and which you cannot.

    • If pharmaceutical companies value the FDA seal of approval, then they can pay the FDA to evaluate their drugs.
    • If consumers value FDA approval, then they can decide to only buy FDA approved drugs.

    If the FDA’s seal of approval is really so valuable, then it does NOT need to be mandatory. No coercion is necessary. Instead, the FDA should be able to sell its services through voluntary means, just like Underwriter’s Laboratory does.

    Consumers and doctors should be free to consult available science, and make their own decisions about which treatments to try.

    All human beings are unique. Treatments that might be dangerous for one person, could be the only possible solution for another. There is zero chance that one-size-fits-all dictates can possibly account for the vastness of human variability. Patients and doctors must have the flexibility to deal with individual human uniqueness.

    The FDA should serve, not rule.

    Talking Points:

    There are thousands of reasons why the FDA should lose its power to coerce you and your loved ones. Some of these reasons will be listed below, so that you can use them when writing to Congress, or when asking your friends to contact Congress on this issue . . .

    The FDA gives consumers a false sense of security. Americans assume that the FDA is actually protecting them, but it is not. For instance . . .

    The Union of Concerned Scientists surveyed 6,000 FDA scientists in 2006, and 1,000 of them responded with the following disturbing admissions:

    • 17% admitted that they had been "asked explicitly by FDA decision makers to provide incomplete, inaccurate, or misleading information to the public, regulated industry, media, or elected/senior government officials."
    • Less than half agreed that the FDA "routinely provides complete and accurate information to the public."
    • 47% admitted to being aware of instances "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal, or modification of FDA determinations of actions."

    The FDA is constantly attempting to expand its powers. The people in that agency are relentlessly pushing into areas that are NOT part of their mandate — even where there is NO problem that needs to be fixed.

    For Example: The FDA has made repeated attempts to regulate vitamins and supplements, even though there is no evidence that these things present any danger. Quite the contrary — vitamins and supplements are a powerful example of how health outcomes can be improved, without FDA involvement. The website of the Life Extension Foundation is full of scientific citations to demonstrate this. For instance . . .

    A review of 2009 information for "adverse events" reported to the national control center’s data system shows that, NO major adverse events or deaths were reported for . . .

    • Botanical supplements like St. John’s wort, ginseng, and Echinacea
    • Hormone supplements like DHEA, melatonin, and pregnenolone
    • Phytoestrogen supplements
    • The joint- and cartilage-support supplements glucosamine and chondroitin
    • Vitamins A and E, and only one adverse event each was reported for vitamin B6 and C

    In total, 41 major adverse events were reported for the entire spectrum of supplements including botanicals, amino acids, and vitamins, and only one was a death.

    In contrast, more than 7,000 major adverse events were reported for pharmaceutical drugs, including a total of 496 deaths. And based on previous studies, we know the overall death rate for physician prescribed drugs to be far higher.

    The Downsize DC position is pro-choice. The FDA should serve, not rule.

    Use the form at right to send your elected representatives a letter about this issue. It’s easy!

    • Your position will be counted by each Congressional office,
    • Will educate the Congressional staffer who reads it,
    • May be passed up the chain of command,
    • May receive a reply (many DC Downsizers get them). If you receive such a letter, please share it with us at Comments@DownsizeDC.org.

     

    Send a letter to Congress

    We provide the first few words of the letter so that Congressional offices will see the most important point

    right at the start, and so that no one can hijack our system for another purpose.

    Here’s the part we provide . . .

    Make the FDA advisory, not mandatory.

    LINK

    CONTINUE READING….

     
  • ShereeKrider 1:50 am on February 7, 2015 Permalink | Reply
    Tags: , , , FDA, , , , , ,   

    Prohibition Repeal Is A Good Model For Marijuana Legalization 


    9:51 AM 12/05/2014

    Marijuana plants for sale are displayed at the medical marijuana farmers market at the California Heritage Market in Los Angeles, California July 11, 2014.  REUTERS/David McNew

    Today is the 81st anniversary of the repeal of federal alcohol prohibition.

    The 21st Amendment ended the failed experiment of Prohibition and delegated the issue of alcohol legalization and regulation solely to the states.

    The 21st Amendment was neither “for” nor “against” alcohol. It was simply an acknowledgment that federal prohibition was an obvious failure and a nod towards state’s and individual rights. No state was required to legalize alcohol. It was their choice.

    The repeal of prohibition has been a tremendous success. This country has the best regulated beverage alcohol industry in the world while still being the world’s most dynamic. Just ask any beer drinker!

    Fast forward to the present. Republicans made huge gains in last month’s elections, decisively winning control of the Senate, increasing their dominance in the House to a level not seen since the 40’s, controlling 33 governorships and more state legislators than any time since the 1920s. They now have the opportunity to cement and expand these gains and to create a permanent majority.

    How? By leading the charge to end the federal prohibition of marijuana. You don’t have to be “pro-cannabis” to be against prohibition.

    Like it or not, illicit marijuana is available in every corner of this country. Any teenager can get it with little effort. Most say it’s far easier to get than beer.

    Criminal gangs across the country rake in tens of billions of dollars each year selling marijuana. Milton Friedman once said, “See, if you look at the drug war from a purely economic point of view, the role of the government is to protect the drug cartel. That’s literally true.”

    In 2012, 750,000 people were arrested for mere possession. That’s about one arrest every 48 seconds! And a disproportionate number of the people arrested on marijuana-related charges are minorities.

    The federal prohibition of marijuana has been as profound a failure as the attempted federal prohibition against alcohol. The solution is the same. Let the states decide and regulate as they see fit.

    Here in Colorado, the legalization of marijuana has been a resounding success. Teen use is down. Auto fatalities are at near historic lows. Crime is down across the board. Tax revenue is flowing in.

    If Republicans want to expand their base, they need to show they truly believe in a liberty-based agenda. Reach out to groups that historically have not been favorable to the Republican brand and prove through action that they have much more in common than they might think. Individual freedom is a winning message for people of all colors and all walks of life.

    Republicans in Congress should pass legislation within their first 60 days in office repealing federal prohibition and placing the issue with the individual states and their citizens.

    A statement such as, “I’m personally against it but believe in the wisdom of the people” can be a get-out-of-jail-free card for all who fear being branded pro-marijuana. The issue isn’t for or against marijuana but rather whether a legal, state regulated market is preferable to a prohibition market. Alcohol or marijuana, the answer to this is clear.

    The alternative is Republicans turning off another generation of voters who think of them as the party that speaks of individual freedom but whose actions suggest they want to control other people’s lives. These folks have seen the failure of big government and most big institutions. Their loyalty can be obtained, but the party has to walk the walk.

    Think I exaggerate? Here in Colorado, the Republican challenger for governor was ahead by 10 points in a September poll. Then, showing the Republican skill for snatching defeat from the jaws of victory, he stated he would like to recriminalize marijuana. His lead evaporated almost overnight.

    He lost by 58,000 votes and singlehandedly damaged the Republican brand for a generation of young Colorado voters. There are over 10,000 people directly employed in this Colorado industry and hundreds of thousands of consumers. That’s a lot of voters to antagonize; many of them motivated single issue folks.

    What if the GOP could create a new supporter every 48 seconds rather than trying to throw them in jail?

    Freedom and liberty win. Prohibition and attempting to control people’s lives loses. Republicans, if you believe what you say, end the federal prohibition on marijuana. A permanent majority awaits. It is yours for the taking.

    John Conlin is a self-employed management consultant providing services to beer, wine, and spirits distributors across the country. He is also in the process of starting a marijuana-infused edibles company.

     

    CONTINUE READING…

     

    Tags: John Conlin, Marijuana, Prohibition

     
  • ShereeKrider 4:18 pm on April 1, 2012 Permalink | Reply
    Tags: , , , , , endocannabinoids, , FDA, , , , , human, , , , , , , , vote, , Warfare and Conflict   

    Absolute Asinine Laws 


    Life in Prison for Hemp

    José Peña brought some roadside weeds home from Kansas. Cops decided it was reefer, and a Texas court sentenced him to life in prison – without the evidence. It took a decade for Peña to get back some of the pieces of his life.

    By Jordan Smith, Fri., March 16, 2012

    Life in Prison for Hemp

    José Peña was tired as he drove south toward Houston on the morning of Sept. 27, 1998. Following a quick trip north to Kansas in a rented van – to pick up the brother of a distant cousin’s son – he was on his way home to Houston, where he lived with his wife and four children. It was the kind of favor Peña often did for friends and family, no matter how distant the relation – and the kind of favor that irritated his wife. “I was tired, and I was trying to get home,” the 50-year-old recently recalled. “My wife was mad at me for doing favors for other people” when he could instead be home.

    That morning, just before 8am, Peña was cruising south down I-45, a little more than two hours from home. He was driving in the right-hand lane through Leon County when he passed a state trooper sitting in his car on the grass median. He thought nothing of it – just another Texas trooper on a long and nondescript stretch of highway – until he noticed the trooper pull out onto the road and follow him. The officer, Mike Asby, a veteran member of the Texas Department of Public Safety, drove in the left lane until his car was parallel with Peña’s. Peña looked over at Asby. “He pulled up next to me, and I looked at him because I wasn’t not going to make eye contact” with an officer whom Peña thought was definitely checking him out for whatever reason.

    Although Peña steadfastly maintains that he wasn’t doing anything wrong or unusual, Asby would later testify that Peña caught his attention because he was driving more slowly than the rest of traffic in a van caked with mud; when the van “weaved across the center stripe and also across the solid yellow line on the shoulder,” Asby testified in January 2003, he had to take action. “You’re required to stay in a single lane of traffic,” he said. He activated his lights and pulled Peña over.

    Within the hour, Peña would be in handcuffs in the back of the trooper’s car, headed to the county jail in Centerville on a charge of marijuana possession. Nearly five years later, Peña would be convicted and sentenced to life in prison for possession of what the state said turned out to be 23.46 pounds of freshly cut marijuana that Peña was transporting in the back of the muddy blue van. Although Asby testified that this was not a normal highway drug bust – “normally,” he testified, marijuana moves north from Houston, already “dried out, cured, and ready to be sold” – he was certain that what he found casually laid out in the back of the van was pot because it smelled like pot – and he knows pot when he smells it. “It’s something that you learned in [28] years of experience being on the road?” prosecutor Whitney Smith (now Leon Coun­ty’s elected D.A.) asked Asby.

    “Yes, sir,” Asby replied.

    Just Trust Us

    There are at least two problems with the official story of Peña’s arrest and prosecution. First, Peña is adamant – and has been since 1998 – that what he was transporting was not marijuana, but actually hemp, pot’s non-narcotic cousin. Peña says he found the plants growing wild in Kansas and cut them down, thinking that he could use the stems and leaves in the various craft projects he made with leather and wood in his garage workshop; there was no doubt in Peña’s mind that what he was transporting was not marijuana. The second, and eventually more decisive problem with the official story of the Peña bust, is that prior to his trial, officials with the Department of Public Safety lab in Waco, where the plants were taken for testing, completely destroyed all of the case evidence – all 23.46 pounds of plant material – and then also lost the case file with all of the original documentation of the lab’s work on the case. By the time Peña was finally tried – more than four years later – there was absolutely no evidence to show the jury; instead, the state relied completely on the “experience” of Asby and of Waco lab supervisor Charles Mott (now retired) to persuade jurors that what they say they saw and tested was actually marijuana.

    It worked.

    That is, it worked until late last year, when Peña’s conviction was finally overturned by the Court of Criminal Appeals, the state’s highest criminal court, and Leon County subsequently dismissed the charges for good. In the intervening decade, however, Peña’s case became a political hot potato, catching the attention of judges and lawyers across the state who watched as the 10th Court of Appeals, based in Waco, played tug-of-war with the Austin-based CCA over the power of the Texas Constitution, and whether it affords citizens greater rights and protection against state power than does the U.S. Constitution.

    It’s a conflict that has left the state of Texas divided and may mean – at least for the time being – that persons tried for crimes in one part of the state will be afforded greater protection from prosecutorial errors or malfeasance than are others. Frankly, says Keith Hampton, an Austin defense attorney who represented Peña just before his case was dismissed, you just “don’t see this happen very often.” Ulti­mate­ly, whether the protections gleaned from the Texas Constitution by the 10th Court will remain in force and be applied to all Texans is still to be determined.

    Weeds, Not Weed

    Peña had a knack for creating handcrafted leather and wood items that sold like hotcakes, he says, at flea markets in and around Houston. He made personalized shellacked plaques and leather key chains with popular first names spelled out in tiny beads, and at a dollar a key chain, they sold well. So when he first saw the hemp plants growing on the roadside near Manhattan, Kan., they gave him an idea. He would take the plants – which, to an untrained eye, look exactly like marijuana plants – press the leaves, and then use them on plaques or affixed to the small leather wallets that he also had become expert at making. He recognized these as “volunteer” hemp plants – they grow wild across the country, reminders of the days when hemp farming was commonplace and even, during World War II, encouraged by the feds as supporting the war effort. By the Kansas roadside, they were scraggly and abundant. When he pulled into the Tuttle Creek State Park outside Manhattan, and saw the plants growing everywhere, he “loaded … up.”

    Indeed, Peña thought nothing of the fresh-cut plants that he’d laid out in the back of the blue van he was driving. He knew – partly from experience of having smoked pot when he was younger, and partly because he knew that hemp was once a major agricultural commodity – that the plants were nothing more than weeds that looked like weed.

    However, that’s not how Asby saw it. To him, it was clear that one thing, and only one thing, was taking place. Peña was moving a large amount of marijuana to Houston – as unusual as that might be, Asby acknowledged.

    Peña repeatedly told Asby that the plants were hemp, and his insistence clearly gave some pause to Asby and the two backup officers who soon joined him. The three men stood next to the van pondering the notion that a plant could look like, but not actually be, marijuana. “I … questioned them, I said, ‘Well, he says it’s not marijuana,'” Asby recalled in court. “I knew that there was a substance called hemp and I was asking them. … And I asked them, ‘You ever heard of something like marijuana, just hemp, that is legal to have?'” he continued. “I don’t know that there is a legal kind. That was the question I was asking the officers: ‘Have you ever heard of this … where marijuana was cut and it turns out to be legal?'”

    In the end, Asby was unpersuaded. “I just know marijuana smells like marijuana,” he testified in 2003. “And I have never found anything that I thought was marijuana that wasn’t.” He cuffed Peña and hauled him off to jail.

    Page:   1   |   2   |   3   |   All

     
  • ShereeKrider 4:35 pm on March 25, 2012 Permalink | Reply
    Tags: , , FDA, , , , , , , prosecutor   

    U.S. attorney breaks silence on medical-marijuana battle 


    U.S. attorney breaks silence on medical-marijuana battle

    Details from last week’s Benjamin Wagner chat with press and pot advocates

    By David Downs
    Read 10 reader submitted comments

    This article was published on 03.08.12.

    Medical-cannabis patients and providers should expect ongoing persecution in California. However, media backlash due to the nearly half-year-old federal crackdown is affecting at least one prominent drug warrior: United States Attorney for the Eastern District of California Benjamin Wagner.

    Wagner broke the Department of Justice’s near silence with regard to the crackdown during a candid, hour-long talk and question-and-answer session last Tuesday at a Sacramento Press Club luncheon. The $30-a-plate affair took place on the 15th floor of 1201 K Street, and inside, Wagner admitted that the cannabis cleanup was the idea of the four U.S. Attorneys in California, not Washington, D.C.

    The four were upset because of what Wagner called “flagrant” marijuana sales in the state. So they declared war on medical marijuana last October, sending out hundreds of forfeiture-warning letters to dispensaries across California. His office is in the process of seizing at least one dispensary in Sacramento, while officials have closed more or less every dispensary in Sacramento County.

    He reiterated that they’re not going after patients and caregivers, rather interstate transporters, huge pot farmers and illicit dispensaries grossing tens of thousands of dollars per day in cash.

    But the media critique of the war is wearing on Wagner, it seems. He said he counts on good press to create a “deterrent effect” in regard to cases of mortgage fraud, child exploitation, human trafficking and major gang violence. But he’s not getting any of that.

    “I think that the members of the press would be forgiven for thinking that marijuana enforcement is all that we do,” he said. “It is far from the most important thing that we do. I have many other higher priorities that have a much bigger impact on public safety. I did not seek the position of U.S. attorney in order to launch a campaign against medical marijuana.”

    Wagner was appointed by President Barack Obama in 2009 and has been with the DOJ since 1992, primarily in the Eastern District. When he and the other three U.S. attorneys took office at the end of 2009, “We found that we were in the middle of an explosion of marijuana cultivation and sales,” he said.

    Federal policy didn’t change, rather “what we saw … was an unregulated free-for-all in California in which huge amounts of money was being made selling marijuana … to virtually anybody who wanted to get stoned.”

    Wagner said that’s not what California voters approved. Stores marking up pot 200 percent is “not about sick people. That’s about money.”

    His reaction has been “quite measured,” he said. Most dispensaries just got warning letters.

    “In a few instances, after ample warnings, we’ve brought civil-enforcement actions while reserving criminal prosecution for the most flagrant violators of not only federal law but state law,” he said.

    He referred to cases such as one where seven Roseville and Fresno suspects were indicted in February for growing pot with doctor’s recommendations and running a dispensary as a front to traffic it to seven states in the Midwest and South.

    Wagner also warned that a season of raids in the Central Valley is coming in 2012, and that mega pot farmers are on notice that if they plant again this year, their land could be seized.

    He tried to make the case that pot is just a fraction of what his office does, referring to 61 indictments on mortgage fraud last fiscal year.

    During audience questions, activists asked why the federal government says marijuana has “no medical use,” yet the United States has patented its ingredient, cannabidiol, for treating strokes.

    “What I know about marijuana as medicine you can probably put in a thimble,” he said.

    But health policy is not his job, he said. “My advice to you is to write your congressman.”

    Sacramento lawyer Alan Donato asked for guidelines for local dispensaries to avoid federal attention.

    “I’m not in a position to be of much comfort,” Wagner said. “You don’t ask the CHP, ‘How many miles over the speed limit can I go before you pull me over?’”

    Stephen Downing, a retired Los Angeles Police Department deputy chief and member of Law Enforcement Against Prohibition, asked if the failed drug war would ever make Wagner say “Enough is enough” to his boss, Attorney General Eric Holder.

    “That’s hard to say,” Wagner said. “I totally understand the debate over legalization as opposed to criminalizing narcotics.

    “It really depends on what the cost-benefits are. Marijuana is obviously not nearly as destructive as [methamphetamine]. The risks in legalizing marijuana may be significantly less that meth.”

    But prescription drugs “are the biggest, worst drug problem in terms of trends … [and] that’s a legal drug.”

    SN&R news intern Matthew W. Urner got the biggest attention of the lunch, asking Wagner if he ever tried the second-most-commonly used mind-altering substance in America, and if so, what he thought.

    “Uh,” said Wagner, “I’ll say that I went to college.”

    CONTINUE READING…

     
c
Compose new post
j
Next post/Next comment
k
Previous post/Previous comment
r
Reply
e
Edit
o
Show/Hide comments
t
Go to top
l
Go to login
h
Show/Hide help
shift + esc
Cancel
%d bloggers like this: