Great news! The Senate Farm Bill just passed - and it includes ALL of the Hemp Farming Act, including the permanent legalization of hemp and products such as hemp-derived CBD.
This is HUGE. But the battle has not yet been won. And we need your help.
A House/Senate conference committee will soon meet to resolve the differences between the Senate Farm Bill and the House Farm Bill, the latter which includes no hemp language. Senate Majority Leader Mitch McConnell will be leading the fight to ensure that the conference committee retains the hemp-friendly Senate language before it gets sent back to the House and Senate floors for final passage.
Please help TODAY.
We've revised our online portal to make it easy for you to contact both your Senators and your Congressman, to urge them to support the Senate Farm Bill's hemp provisions.
Please go there NOW and have your voice heard. And as always, please share this portal with your friends, colleagues, customers and social media contacts. Together, we can make permanent hemp legalization a reality.
June 25, 2018
Food and Drug Administration
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the "high") that comes from tetrahydrocannabinol (THC).
It is THC (and not CBD) that is the primary psychoactive component of marijuana.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development," said FDA Commissioner Scott Gottlieb, M.D. "Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases."
Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.
Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.
"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life," said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition."
Epidiolex's effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.
The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.
Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare, but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.
Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD.
The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.
The FDA granted Priority Review designation for this application. Fast-Track designation was granted for Dravet syndrome. Orphan Drug designation was granted for both the Dravet syndrome and Lennox-Gastaut syndrome indications.
The FDA granted approval of Epidiolex to GW Research Ltd.
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.
SENPA, Inc. Expands Education and Trade Show in Southwest
New Port Richey, FL - June 14, 2018- The Board of Directors of SENPA, Inc. a non-profit trade association, is pleased to announce the expansion of educational offerings in the Southwest area including the first Strategies for Success Road Show to be held August 5th in Houston, TX and production of a table top buying show SOHO Healthfest for independent natural retailers in the Spring of 2019.
"After months of discussion the NPA-SW's board made the difficult decision and voted to dissolve their association at their annual business meeting held on April 8th, " said Michelle DuFresne -VP KeHE Distributors Natural Independents East/Central and SENPA President. "SENPA leadership had been working with the NPA-SW board for several months exploring the opportunities of extending membership and providing additional opportunities to their association, and we are excited to bring their members into the SENPA family."
"Although Healthfest has seen growth over the past few years, the current board and membership believes the association needed to re-evaluate the educational support being offered to the membership," said Howard McQuay - President NPA-SW. "The Board of Directors of NPA-SW feels confident SENPA can give the Southwest area the trade shows and educational programs that are needed to grow our industry."
SENPA, Inc. will work with NPA-SW membership and extend dues and privileges of membership with SENPA through the 2018 fiscal year and those SW members who were also members with SENPA will be offered dues and privileges through the 2019 fiscal year.
"SENPA is mindful of the Independent Retailer," said Debra Short, Executive Director SENPA. "With top notch education, networking, and proven innovative trade shows, retailers remain up-to-date in the natural products industry. We remain committed to being their resource for education."
About SENPA: SENPA's mission is to support the natural products industry through education, networking and advocacy for the right to buy and sell natural products by empowering healthy choices and business development. SENPA produces SOHO EXPO, Strategies for Success Road Shows, and Intensive Education CEU programs throughout the year. These programs offer members the chance to hear from highly qualified Doctors and industry leaders on the latest in nutrition in the natural products industry. To learn more visit www.SENPA.org.
SOHO EXPO produced by SENPA is The Largest Independent Natural Products Industry Trade Show. All proceeds go back into the industry to educate independent retailers and their staff. SOHO EXPO also supports growth in the natural products industry by encouraging new companies the opportunity to network with prime decision makers (60% of attendees are prime buyers at SOHO Expo) about their products. Visit www.SOHOexpo.net for more details.
Executive Director SENPA
5946 Main Street, New Port Richey, FL 34652
U.S. Hemp Roundtable asks for Immediate Action
At least 37 states have passed legislation related to industrial hemp. State policymakers have worked to address policy issues to address definition of hemp, lincensure of growers, regulation of seeds, and state wide consideration of growers.
The U.S. Hemp Roundtable is asking for your consideration and help today.
Late Tuesday afternoon, U.S. Sen. Chuck Grassley (R-IA) filed an amendment to the 2018 Farm Bill which would devastate the industry's efforts to promote full legalization of hemp and hemp products. Specifically, Grassley's amendment (here) would explicitly exclude "cannabinoids," "extracts" and "derivatives" from the definition of hemp. This could mean that popular products such as hemp-derived cannabidiol (CBD) may be treated by the DEA as a Schedule 1 controlled substance - akin to heroin. Cynically, Sen. Grassley has also included language that would provide for research on medical marijuana - even though hemp products do not contain more than trace amounts of THC, the psychoactive compound in marijuana.
It is critical that we block this last-minute effort to try to sink the bi-partisan Hemp Farming Act. If we apply enough political pressure, Senator Grassley might even withdraw his amendment from consideration.
Please go right NOW to our online portal to urge your US Senators to vote "no" on the Grassley Anti-Hemp, Anti-Farmer amendment. It is especially critical to contact your Senator if s/he is a Member of the Senate Agriculture Committee (check the roster here). If it is not withdrawn, the Grassley Amendment could come up for a vote as early as tomorrow (Wednesday) as the Committee begins markup on the Farm Bill.
Please share this message via email and social media with your customers, friends, and contacts. Hemp Supporters are needed NOW to fight this effort to undermine the booming hemp industry and the great work of our bi-partisan supporters on Capitol Hill. Please act NOW.
UPDATE: FDA Rule Extends Deadline for Compliance on Nutrition Facts Label and Serving Size Rule
The Rule for food and beverage manufacturers with sales greater than $10 million required to be in compliance by July 26, 2018 has now been extended to January 1, 2020. The deadline for companies with sales below $10 million has been extended from July 26, 2019 to January 1, 2021 to comply with new rules.
FDA is taking this action because they have determined that additional time would help ensure all manufacturers covered by the final rules would allow for sufficient time to complete and print updated Nutrition Facts Labels before they are expected to be in compliance.
Background from July 2016 Rule:
Requires declaration of Vitamin D and Potassium and permits rather than requires the declaration of vitamins A and C
Declaration of a gram of amount of added sugars defined and listed to Total Sugar
Updating certain reference values used in the declaration of percent Daily Values Of nutrients on the Nutrition Facts & Supplement Facts labels
Revising the format of the Nutrition Facts and Supplement Facts labels to increase the Prominence of the term "Calorie"
Removing the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets
Serving size has changed based on the typical serving consumed at one time.
The FDA has issued an extension of the comment period until June 15, 2018for the notification of availability of a draft guidance entitled "The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products" [FDA-2018-D-0075] that appeared in the Federal Register on March 2, 2018. The draft guidance will advise food manufacturers of the FDA's intent to exercise enforcement discretion related to the use of the Nutrition Facts label of the symbol immediately after the added sugars percent Daily Value information on certain foods. The draft guidance explains the FDA intends to consider exercising enforcement discretion for the use of this symbol on single ingredient packages and/or containers of pure honey or pure maple syrup, and certain dried cranberry and cranberry juice products that are sweetened with added sugars, and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars.
According to this guidance, the symbol would lead the reader to truthful and non-misleading statements outside the Nutrition Facts label to provide additional information regarding added sugars present in particular foods.
CALL TO ACTION:
On March 29, 2018, SENPA informed you about Organic & Natural Health Association submitting a petition to the FDA on the association between Vitamin D and reduced risk in preterm births.
Today we are asking for your voice to be heard!
Please take a moment to click here. It will take only 30 seconds to automatically send a letter to your senators and congressmen.
(This Thursday April 12th, SENPA representatives will join Organic & Natural Health Association team to help share this message on ONHA's Hill Day in Washington, DC).
Organic & Natural Health Association Submits Petition to FDA for Vitamin D, Preterm Birth Health Claim
WASHINGTON, DC (March 28, 2018) - Organic & Natural Health Association submitted a petition to the FDA, requesting that the agency permit dietary supplements containing vitamin D to make a health claim concerning the association between vitamin D and a decreased risk of preterm births. The nutrition trade organization has asked the FDA to acknowledge numerous studies showing an association between higher serum vitamin D levels in pregnant women and a reduced risk of preterm births. Organic & Natural Health believes that such a claim will help raise awareness of preterm births, a risk factor for pregnant women, reduce the cost of health care associated with preterm births, and empower women to take affirmative steps for the health of their children.
Every day in North America, more than 1,000 babies are born prematurely. In fact, the United States has the highest rate of babies who die the day they are born in the industrialized world according to Save The Children, which reports that 130 countries have lower preterm birth rates than the United States. Further, the CDC's National Center for Health Statistics reports no sign of improvement of infant mortality, and reports women of Asian ethnic origin showing the lowest rates of preterm births, at 8.6 percent, while African-American women experience the highest rates, at 13.75 percent of all births.
Recently published research conducted at the Medical University of South Carolina in partnership with GrassrootsHealth, shows pregnant woman who maintain vitamin D levels of 40-60 ng/ml, experience a reduction in preterm births by up to 60 percent. Out of the 1,000 pregnant women studied, 90 percent were deficient in vitamin D. During the study, researchers did not find a single complication related to pregnant women taking vitamin D.
"Vitamin D is inexpensive and has been shown to be safe at the recommended level," said Carole Baggerly, director of GrassrootsHealth and co-author of the paper. "We have several medical centers ready to implement a new standard of care with our vitamin D 'Protect Our Children NOW' campaign."
The March of Dimes estimates that the annual cost of preterm births in the United States is $12 billion, for 455,918 children. States with the highest preterm births include: Alabama, Arkansas, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Maryland, Mississippi, Missouri, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, Texas and West Virginia, as well as Washington, D.C. States where 10 percent or more of women received late prenatal care or no prenatal care include: Arkansas, New Mexico, Texas and Vermont.
"If 50 percent of preterm births could be prevented each year in the United States, there could be nearly $6 billion available for other health services and more than 225,000 families would be spared this trauma," said Karen Howard, CEO and executive director of Organic & Natural Health. "MUSC changed its standard of care for its pregnant patients and is now monitoring vitamin D levels based on their research. We are confident that members of Congress, their constituents, health insurers and employers will see the value in this health claim related to vitamin D levels and a reduced risk of preterm births."
Organic & Natural Health will take a select team to Capitol Hill to share this message on its April 12 Hill Day, meeting with key legislators and staff, and presenting the research at an informational luncheon at noon in room 340, the Cannon House Office Building. Members of Congress and the media are invited to attend. To view the FDA Submission, click here.
SENPA will join the Organic & Natural Health Association team to help share this message on ONHA's April 12th Hill Day in DC.
Thank you to AHPA for sharing this latest news.
Editor's Note: Indiana Gov. Eric Holcomb signed a measure legalizing low-THC cannabidiol oil in the state, after nearly a year of confusion over Indiana's laws. The bill signed by Holcomb requires manufacturers to test each batch of product to ensure it has less than 0.3 percent THC. The law will likely require most CBD oil manufacturers to create new labels for products sold in Indiana because it requires product labels to include a QR code that links to information on the batch.
March 21, 2018
CBD oil is now legal in Indiana after nearly a year of confusion
Senate Enrolled Act 52 allows any person to buy, sell and possess CBD oil, as long as it meets certain labeling requirements and contains no more than 0.3 percent THC, the substance that produces a "high."
Some lawmakers, however, worried the bill's requirements were too stringent and would accidentally cut manufacturers out of the industry and cause prices to jump.
The bill is also silent on the legality of manufacturing the product in Indiana, which could lead to more legal debates in the future.
FDA issues guidance on added sugar, dietary fiber, serving sizes
By Elaine Watson
The FDA has unveiled guidance on added sugars, serving sizes and dietary fibers to help manufacturers implement the new Nutrition Facts label, and says it's working on a plan to incentivize manufacturers to make healthier products and "provide consumers with helpful tools to make healthy food choices, including clarity on food label claims."
Let Your Voice be Heard ......
Use your voice to protect organic! When choosing to buy organic products there are expectations about what organic really means. On December 18 the USDA issued a proposed rule to withdraw the Organic Livestock and Poultry Practices (OLPP) final ruling expected to take effect March 20, 2018 after being delayed 3 times. The USDA ruled that animals in "organic" products need not be treated any more humanely than those in conventional farming. This USDA action goes against the overwhelming support of organic farmers, business and consumers to advance animal welfare standards in organic.
Now is the time to keep organic strong.
TAKE ACTION NOW
The deadline to submit your comments is January 17, 2018.
"The organic sector does not take for granted the trust of the consumers we serve, and we work hard every single day to maintain it. Organic is an opt-in regulated program that ensures products bearing the USDA organic seal meet strict consistently complied standards and provide consumers a meaningful choice. The future of organic rests on consumers trust and the organic sectors depends on the USDA to set standards fairly and according to the law." Laura Batcha, CEO Organic Trade Association.
Let you voice be heard by sharing this information within your community of customers, friends and colleagues. Let the Federal Register know your concerns for fundamental governmental fairness in organic standard setting.
Drug Enforcement Administration adds Code for Marihuana Extracts
The registration of marihuana extracts will take effect January 13, 2017 according to a notice filed by the DEA. The notice defined marihuana extract as “containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.”
Still being regarded as a Schedule 1 controlled substance, requiring an Administrative Controlled Substance Code number “7350”, will allow the DEA to tract the material and aid in compliance with international drug control treaties.
The Administrator, in accordance with the Regulatory Flexibility Act (RFA) has reviewed this rule and by approving it, certifies that it will not have significant economic impact on a substantial number of small entities/businesses. The DEA already registers persons handling marihuana extracts but within another already established drug code 7360 and those persons who handle these marihuana extracts have already met DEA’s registration, security, and other statutory and regulatory requirements. The only direct effect to registrants will to require the addition of the new drug code 7350 to their registration.
SENPA will continue to keep you updated on information that will affect your business.
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SENPA's Mission and Vision Statement
SENPA's mission is to support the natural products industry through education, networking and advocacy for the right to buy and sell natural products by empowering healthy choices and business development.
SENPA strives to be the preferred resource for education, networking & advocacy in the natural products industry.
SENPA Inc. 727-846-0320 info@SENPA.org