One of the most Unique products on the market today!!!
EUPHORIX is Back
Come see what all the hype is about….
One of the most Unique products on the market today!!!
EUPHORIX is Back
Come see what all the hype is about….
By: John Long
In a letter to a member of Congress, FDA acknowledged it failed to clearly convey some of its views regarding five-year-old draft guidance governing notifications of new dietary ingredients (NDIs).
In reviewing comments related to the draft guidance and meeting with consumers and the dietary supplement industry, “it became clear that there was considerable misunderstanding about parts of the draft guidance and that, in some cases, our views were not stated clearly,” an FDA official, Dayle Cristinzio, wrote in a March 10, 2016 letter to Rep. Jason Chaffetz, a Republican from Utah.
Cristinzio advised the congressman that FDA was “in the later stages of preparing the revised draft NDI guidance” and hoped “to publish this document in the near future.”
The letter, which INSIDER obtained Thursday from FDA through a Freedom of Information Act request, makes clear that the new draft guidance will not be final.
“We want to stress that we are publishing a revised draft guidance, rather than a final guidance, to provide the public and interested stakeholders with a further opportunity to comment,” Cristinzio, FDA’s Acting Assistant Commissioner for Legislation, stated.
Industry sources have described release of the new document as “imminent” and said it could be unveiled in the coming weeks in response to criticisms that the July 2011 guidance poses undue burdens to companies and is contrary to the 1994 Dietary Supplement Health and Education Act (DSHEA).
“We’re happy to see that the agency is making this [guidance] a priority and hopeful that it will be out soon,” said Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA).
Under DSHEA, an NDI is considered “adulterated” unless the “dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered”; or FDA receives a notification at least 75 days before the new substance is introduced into the market, establishing that the product containing the new ingredient “will reasonably be expected to be safe.” As INSIDER has reported, three out of four NDI notifications have been met with some type of an objection by FDA, such as a finding there is inadequate safety data or the company failed to sufficiently describe the ingredient.
“The revised draft guidance will clarify matters that were not clear in the 2011 draft guidance or that were subject to misinterpretation,” Cristinzio wrote. “The purpose of issuing guidance on the topic of New Dietary Ingredient … notifications is to provide clear recommendations on when firms should file such notifications and what information should be included in a notification. In other words, the guidance is intended to provide information and tools to help companies meet their statutory obligation to ensure that dietary supplements containing NDIs are reasonably expected to be safe.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), looked forward to FDA offering guidance on information that companies should include in an NDI notification. He referenced NDI submissions that are rejected by FDA for obvious reasons, such as failure to sufficiently characterize the nature of the ingredient or failure to disclose the manufacturing process to confirm the ingredient can be made consistently.
“Things like that are things that the industry absolutely needs in a guidance so that we don’t have these rejections for silly reasons, [and] the industry understands going into the NDI notification process what’s expected in that submission,” Mister said in a phone interview.
Chaffetz’s office did not immediately respond Thursday to a request for comment. Neither did the White House’s Office of Management and Budget, which must review the draft NDI guidance before it is published.
In writing to FDA earlier this year, Chaffetz reiterated his previous position that the 2011 guidance was inconsistent with the law.
Finally, Mister said the 2011 draft guidance reflects more than just a misunderstanding between FDA and the industry.
“It’s all in how you couch the gulf, the divide, between the industry and the agency,” he said. “We saw it as more than just a, ‘Oh you weren’t being clear.’ We saw it as, ‘No, you got it wrong in some cases and so this is your chance to re-evaluate the position and come back and get it right.’”
Amidst a surge of opioid abuse in the United States, opioid users are turning to natural botanicals in order to mitigate the effects of withdrawal from opioids. Kratom is a natural botanical from Southeast Asia.
1. Kratom emulates the effects of an opioid at a lower magnitude, and is about as addictive as coffee. Because of these properties, opioid users are turning to Kratom to help manage opioid withdrawal symptoms.
2. Kratom also has a variety of other properties. It has commonly been used in Thailand by rubber plantation workers to relieve minor pain, enhance their sense of well-being, and extend their stamina.
3. In low doses, Kratom can assist with mood elevation, and an increase in alertness.
4. Despite its growing domestic user population and history of traditional use throughout South Asia, Kratom has not been researched by the FDA. The lack of conclusive data from government-led clinical studies and research has led to complications in its legalization and regulation.
5. Without data, the federal government is unable to definitively declare Kratom’s legality. And instead, it has to be approved or disapproved on a state-by-state basis under each individual legislature’s set of laws. As of now, Kratom is legal in every state except Vermont, Wisconsin, Indiana, Tennessee, Arkansas, and Alabama.
6. In all of these states except for Arkansas, Kratom is classified as Schedule 1 due to the presence of two chemicals that naturally occur within it that are also present in highly addictive synthetic opiates. Despite research that the addictive risk of Kratom is as dangerous as the addictive risk of caffeine, the state put Kratom in the same category as opiates such as heroin as a blanket measure of sorts.
7. Kratom is also banned in Arkansas, which did not go through the same legislative process as in other states. In this case the sole power to ban any substance is granted to the Director of the Department of Health, limiting the input of the state legislators’ constituents.
8. As of now, five other states are in the process of attempting to enact legislation to ban or restrict Kratom use and possession.
9. Previous attempts to ban have failed in eight other states due to constituents expressing their concerns and discussing the positive impacts of Kratom on their lives.
(NaturalNews) A survey conducted by California medical marijuana company, HelloMD, found that of the 1,400 patients who participated in the survey, 14 percent of them experienced libido-boosting benefits as a result of their marijuana-smoking behaviors.
While the majority of the company’s patients turn to medical marijuana to help manage their chronic pain, improve sleep and treat mood problems, there were those who said it improved satisfaction in the bedroom. New York City sex therapist, Dr. Ian Kerner, notes that people often turn to cannabis to heighten their sexual experiences, especially if a partner has problems with erectile dysfunction (ED).
“For men who I work with who suffer from erectile disorder, smoking pot before they have sex can really help them relax and maintain erection,” says Kerner. He also adds that women who turn to marijuana prior to or during sexual activity have found that it helps them to become more aroused and “… to reach orgasm,” adding that “parts of the brain associated with stress, anxiety and high emotion deactivate,” when smoking pot enters the picture. Furthermore, he adds that senses are heightened; touch in particular is intensified, often making sex more enjoyable among cannabis users.
While he does say that each person’s experience with smoking cannabis differs, and that in some cases, it can make a person’s bedroom activities filled with anxiety, it’s typically associated with a positive outcome.
So, once again, cannabis comes forward as a natural way to benefit people. Of course, in this particular instance we’re talking about sexual activity and boosting libido, something that is a billion-dollar industry for Big Pharma. From Viagra to the more recent advent of what’s been dubbed “pink Viagra for women,” the pharmaceutical industry is profiting big-time from sexual disorders, focusing primarily on ED or those who have a waning interest in sexual activity.
In fact, over 30 million men are estimated to use Viagra. Let’s not forget that other ED-related brands infiltrate the marketplace, including Cialis, Levitra and others. Pill-popping in the name of helping people become more satisfied between the sheets is undoubtedly a big deal, with many individuals wanting to be able to overcome ED issues and/or perform sexually well into their senior years.
While jokes and conversations have run the gamut ranging from Hugh Hefner’s abilities to friends who may discuss the benefits of ED-improving drugs, the reality is that – like most things Big Pharma has its hands in – health problems have been known to occur. For example, less than 10 years after Viagra launched, the brand was linked with leading to vision loss in some people.
Such drugs have also been associated with recreational use, with may people taking these pills in conjunction with other drugs like meth, opioids and ecstasy.
Even athletes have been said to use such swelling-inducing drugs inappropriately, claiming that it helps improve blood vessel and muscle function, and in turn, improve performance.
Another problem comes on the emotional front, with drugs like Cialis and Viagra not having the ability to resolve relationship troubles, despite the fact that couples may be sexually satisfied. People often link the two, assuming that when everything goes well in the bedroom, it can magically improve non-sexual issues. Unfortunately, that’s not true, yet people still flock to these drugs hoping that it’ll do everything from maintain erections to maintain strong relationships.
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Instead of accomplishing that, people are foolishly spending their money, jeopardizing their physical and mental health, and supporting a greedy, multi-billion dollar industry.
Time and again, cannabis has been found to help people overcome a range of problems, without the horrible side effects that are par for the course when it comes to Big Pharma’s pills. Cannabis has even helped sick individuals turn their terminal cancer diagnoses around. It’s healed people who were ill from excessive chemo treatments. It can help improve ED and overall sexual satisfaction, too.
Why would anyone choose health-harming drugs over SOMETHING SO NATURAL AND SAFE?
Sources for this article include:
Our ancestors had solutions for healing, utilizing antibiotics from nature which are still as valid now as they were then.
Oregano and oil of oregano: If you’ve ever had Italian food, chances are good that you’ve had oregano before, and you probably didn’t even realize its health benefits. In addition to its antibacterial properties, oregano also aids in digestion and with weight loss. An oil found in oregano, called Carvacrol, has also been found to fight bacteria that can lead to infection.
Raw apple cider vinegar: This has far-reaching benefits. Daily intake of apple cider vinegar includes antibiotic and antiseptic benefits, while naturally alkalizing your system. It can also help you manage your weight, lower your cholesterol and reduce your risk of developing cancer.
Honey: The ancient Romans knew of honey’s antibacterial properties, using it to treat wounds and prevent subsequent infections. And today, in countries all around the world, honey is still considered to be one of the best natural antimicrobials, anti-inflammatories and antiseptics, in addition to its antibacterial properties. In fact, Manuka honey, found in New Zealand, has been found to have the highest levels of antioxidants and curative abilities.
Turmeric: This brilliantly-colored spice is flavorful, but also has great body protection qualities. In addition, turmeric can be both consumed and applied externally, which makes it a great all-round bacteria fighter. For extra protection, you can mix turmeric with honey and create a paste to apply to skin.
Garlic: Again, more than just a wonderful seasoning, the garlic plant has very powerful qualities. It can fight the common cold, keeping germs at bay before they have a chance to infect you. A compound in garlic – allicin – protects against yeast, parasites, bacteria and more.
Grapefruit seed extract: According to the Journal of Alternative and Complementary Medicine, a study found that grapefruit seed extract is effective against more than 800 known viruses and bacteria, as well as more than 100 strains of fungi and parasites. Besides boosting antibacterial protection, this extract also alkalizes the body and improves gut flora.
Echinacea: Many people are not familiar with this product, but it certainly has wonderful antibacterial qualities. Found in kitchens, this herb has been proven to reduce the amount of colds that the average person may experience in a lifetime. Echinacea has also been found to shorten the duration of colds, but is best taken as a preventative measure.
Cabbage: A cruciferous vegetable, sulfur compounds found in cabbage are effective battlers of cancer, as are kale and broccoli, two other members of the same family. But cabbage also contains a massive amount of vitamin C, with one cup providing up to 75 percent of your daily recommended allowance.
Extra virgin coconut oil: You should be using more coconut oil anyway, because it’s much better for you (because it’s natural) than chemical-laced vegetable cooking oils, but in addition to that, extra virgin coconut oil has anti-microbial and anti-fungal properties, and is packed with antioxidants. Use it to boost your immune system.
Fermented foods: Think unpasteurized cabbage, homemade pickles, kefir and probiotic yogurts – all of which renew our intestinal flora, which in turn protects against cancer and gives us greater ability to fight off infections.
Colloidal silver: This natural antibiotic is a mixture of silver particles that have been suspended in fluid, and has been used for centuries. However, this treatment should only be used on a short-term basis, because too much silver, a heavy metal, can be toxic as well. It works by disabling the enzyme that single-cell bacteria need in order to multiply.
IF YOU ARE FOR ALL NATURAL HERBAL HEALING, YOU MUST TAKE SOME TIME AND CONTACT THESE REPS TO HAVE YOUR VOICES HEARD!!
Well Kratom Warriors! Time again to step up and go to war!! The Bill: https://legiscan.com/NC/text/S830/2015
The NC Government has just filed a bill to ban our beloved plant! The bill is in it’s first round and has not been read yet, so don’t panic yet. At least we found this one before this became another Arkansas situation🙂 We are compiling data for the call to action now and getting a list of people we need to start emailing and contact. Let’s start contacting media in NC for good press and radio stations. We can win this one guys!
Email with how kratom has affected your life for the good, what will happen if this bill passes and that you oppose senate bill S830. Please use your own words, the past few times we made a template – those emails don’t get read using a canned speech.
Thank you guys for your continued help in fighting for our plant my valorious kratom warriors. I have put together an easy copy and paste email list for you below.
John.Alexander@ncleg.net, Chad.Barefoot@ncleg.net, Stan.Bingham@ncleg.net, Harry.Brown@ncleg.net, Ben.Clark@ncleg.net, Warren.Daniel@ncleg.net, Joel.Ford@ncleg.net, Kathy.Harrington@ncleg.net, Brent.Jackson@ncleg.net, Michael.Lee@ncleg.net, Floyd.McKissick@ncleg.net, Bill.Rabon@ncleg.net, Bob.Rucho@ncleg.net, Erica.Smith-Ingram@ncleg.net, Jeff.Tarte@ncleg.net, Terry.VanDuyn@ncleg.net, Andy.Wells@ncleg.net, Tom.Apodaca@ncleg.net, Tamara.Barringer@ncleg.net, Dan.Blue@ncleg.net, Angela.Bryant@ncleg.net, Bill.Cook@ncleg.net, Don.Davis@ncleg.net, Valerie.Foushee@ncleg.net, Fletcher.Hartsell@ncleg.net, Jeff.Jackson@ncleg.net, Paul.Lowe@ncleg.net, Wesley.Meredith@ncleg.net, Louis.Pate@ncleg.net, Shirley.Randleman@ncleg.net, Norman.Sanderson@ncleg.net, Jerry.Tillman@ncleg.net, Joyce.Waddell@ncleg.net, Mike.Woodard@ncleg.net, Deanna.Ballard@ncleg.net, Phil.Berger@ncleg.net, Andrew.Brock@ncleg.net, Jay.Chaudhuri@ncleg.net, David.Curtis@ncleg.net, Jim.Davis@ncleg.net, Rick.Gunn@ncleg.net, Ralph.Hise@ncleg.net, Joyce.Krawiec@ncleg.net, Tom.McInnis@ncleg.net, Buck.Newton@ncleg.net, Ron.Rabin@ncleg.net, Gladys.Robinson@ncleg.net, Jane.Smith@ncleg.net, Tommy.Tucker@ncleg.net, Trudy.Wade@ncleg.net
Senator John M. Alexander, Jr. (919) 733-5850 John.Alexander@ncleg.net Phone: (919) 733-5850
Senator Chad Barefoot (919) 715-3036 Phone: (919) 715-3036 Chad.Barefoot@ncleg.net
Senator Stan Bingham (919) 733-5665 Phone: (336) 859-0999 Stan.Bingham@ncleg.net
Senator Harry Brown (919) 715-3034 Phone: (910) 347-3777 Harry.Brown@ncleg.net
Senator Ben Clark (919) 733-9349 Ben.Clark@ncleg.net
Senator Warren Daniel (919) 715-7823 Phone: (828) 433-0700 Warren.Daniel@ncleg.net
Senator Joel D. M. Ford (919) 733-5955 Joel.Ford@ncleg.net
Senator Kathy Harrington (919) 733-5734 Kathy.Harrington@ncleg.net
Senator Brent Jackson (919) 733-5705 (910) 567-2202 Brent.Jackson@ncleg.net
Senator Michael V. Lee (919) 715-2525 Michael.Lee@ncleg.net
Senator Floyd B. McKissick, Jr. (919) 733-4599 (919) 490-5373 Floyd.McKissick@ncleg.net
Senator Bill Rabon (919) 733-5963 Bill.Rabon@ncleg.net
Senator Bob Rucho (919) 733-5655 Phone: (919) 733-5655 Bob.Rucho@ncleg.net
Senator Erica Smith-Ingram (919) 715-3040 Phone: (919) 715-3040 Erica.Smith-Ingram@ncleg.net
Senator Jeff Tarte (919) 715-3050 Phone: (704) 765-6167 Jeff.Tarte@ncleg.net
Senator Terry Van Duyn (919) 715-3001 Phone: (919) 715-3001 Terry.VanDuyn@ncleg.net
Senator Andy Wells (919) 733-5876 Phone: 828-322-7169 Andy.Wells@ncleg.net
Senator Tom Apodaca (919) 733-5745 Phone: (828) 696-0574 Tom.Apodaca@ncleg.net
Senator Tamara Barringer (919) 733-5653 Phone: (919) 733-5653 Tamara.Barringer@ncleg.net
Senator Dan Blue (919) 733-5752 Phone: (919) 833-1931 Dan.Blue@ncleg.net
Senator Angela R. Bryant (919) 733-5878 Phone: (252) 442-4022 Angela.Bryant@ncleg.net
Senator Bill Cook (919) 715-8293 Phone: (919) 715-8293; (919) 754-3296 (FAX) Bill.Cook@ncleg.net
Senator Don Davis (919) 715-8363 Phone: (252) 341-5548 Don.Davis@ncleg.net
Senator Valerie P. Foushee (919) 733-5804 Phone: (919) 245-3266 Valerie.Foushee@ncleg.net
Senator Fletcher L. Hartsell, Jr. (919) 733-7223 Phone: (704) 786-5161 Fletcher.Hartsell@ncleg.net
Senator Jeff Jackson (919) 715-8331 Phone: (704) 942-0118 Jeff.Jackson@ncleg.net
Senator Paul A. Lowe, Jr. (919) 733-5620 Paul.Lowe@ncleg.net
Senator Wesley Meredith (919) 733-5776 Phone: (910) 867-9595 Wesley.Meredith@ncleg.net
Senator Louis Pate (919) 733-5621 Phone: (919) 658-3637 Louis.Pate@ncleg.net
Senator Shirley B. Randleman (919) 733-5743 Phone: (336) 921-2043 Shirley.Randleman@ncleg.net
Senator Norman W. Sanderson (919) 733-5706 Phone: (252) 249-3749 Norman.Sanderson@ncleg.net
Senator Jerry W. Tillman (919) 733-5870 Phone: (336) 431-5325 Jerry.Tillman@ncleg.net
Senator Joyce Waddell (919) 733-5650 Joyce.Waddell@ncleg.net
Senator Mike Woodard (919) 733-4809 Phone: (919) 599-5143 Mike.Woodard@ncleg.net
Senator Deanna Ballard (919) 733-5742 Phone: (919) 733-5742 Deanna.Ballard@ncleg.net
Senator Phil Berger (919) 733-5708 Phone: (336) 623-5210 Phil.Berger@ncleg.net
Senator Andrew C. Brock (919) 715-0690 Phone: (919) 715-0690 Andrew.Brock@ncleg.net
Senator Jay J. Chaudhuri 919-715-6400 Jay.Chaudhuri@ncleg.net
Senator David L. Curtis (919) 715-3038 Phone: (704) 483-3762 David.Curtis@ncleg.net
Senator Jim Davis (919) 733-5875 Phone: (828)342-4483 Jim.Davis@ncleg.net
Senator Rick Gunn (919) 301-1446 Phone: (336) 229-6981 Rick.Gunn@ncleg.net
Senator Ralph Hise (919) 733-3460 Ralph.Hise@ncleg.net
Senator Joyce Krawiec (919) 733-7850 Phone: (336) 996-3924 Joyce.Krawiec@ncleg.net
Senator Tom McInnis (919) 733-5953 Tom.McInnis@ncleg.net
Senator E. S. (Buck) Newton (919) 715-3030 Phone: (919) 715-3030 Buck.Newton@ncleg.net
Senator Ronald J. Rabin (919) 733-5748 Phone: (919) 733-5748 Ron.Rabin@ncleg.net
Senator Gladys A. Robinson (919) 715-3042 Phone: (919) 715-3042 Gladys.Robinson@ncleg.net
Senator Jane W. Smith (919) 733-5651 Phone: 910-739-5577 Jane.Smith@ncleg.net
Senator Tommy Tucker (919) 733-7659 Phone: (704) 256-9056 Tommy.Tucker@ncleg.net
Senator Trudy Wade (919) 733-5856 Phone: (919) 733-5856 Trudy.Wade@ncleg.net