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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.
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The FDA has issued an extension of the comment period until June 15, 2018 for the notification of availability of a draft guidance entitled "The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products" [FDA-2018-D-0075] that appeared in the Federal Register on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 The draft guidance will advise food manufacturers of the FDA's intent to exercise enforcement discretion related to the use of the Nutrition Facts label of the symbol immediately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 The draft guidance explains the FDA intends to consider exercising enforcement discretion for the use of this symbol on single ingredient packages and/or containers of pure honey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.