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Posts Tagged ‘fda’
Salami Slice
Posted by Kevin Brown on January 1, 2012
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| NEWS RELEASE FDA SALAMI-SLICE STRATEGY CONTINUES
By Lee Bechtel, NHF Lobbyist
The Food and Drug Administration (FDA) has continued to turn a deaf ear to consumers and their health in pushing forward its agenda to remove thousands of safe supplements from the American marketplace The FDA is Deaf and Dumb Daniel Fabricant, Ph.D., the director of the Division of Dietary Supplement Programs at the FDA, again has stated that the Agency has no intention of withdrawing its proposed Draft Guidance for New Dietary Supplement Ingredients (NDIs) that it published last July. The FDA has not changed its position despite receiving over 7,000 comments on the draft industry guidance, which would subject many thousands of supplements to very expensive, drug-like testing and approval requirements in order to stay on store shelves. Fabricant says “alternative approaches” by the FDA to satisfy the FDA’s proposed requirements in the NDI Guidance might be reviewed. However there was no clarification on whether the requirements imposing prescription-drug-like clinical testing and scientific testing to gain FDA approval for supplements sold since 1986 and in the future would be subject to amendment, or dropped from the Guidance. He had previously implied that it could take 3-4 years to resolve these issues but now says the timeline “is really up in the air.” Fabricant’s comments can be read at http://www.nutraingredients-usa.com/Regulation/Fabricant-on-NDI-draft-guidance-Thanks-for-your-146-000-pages-of-comments.-We-ll-get-back-to-you. Interestingly enough, before joining the FDA in February 2011, Fabricant was a vice president with the Natural Products Association (NPA), which makes it very clear that Fabricant has abandoned his obviously sparse roots along with whatever understanding he ever had of the industry. The FDA Blames Industry & Punishes the Consumer More telling about the FDA’s strategy for more heavy-handed regulation is the statement that “If you look at the numbers of NDI submissions versus the number of supplements introduced to the market since 1994, it would appear there is a significant lag in compliance.” On its face, the marketplace has changed over the last seventeen years. But who is responsible for this 17-year lag in compliance? The Dietary Supplement Health and Education Act of 1994 (DSHEA) required manufacturers to submit pre-market notification applications for supplements and new ingredients when there is a history of use or other evidence establishing that an ingredient is safe when used as directed. The FDA has 75 days to accept or reject the application. A non-decision by the FDA means that the Agency accepts the evidence and that the product has complied, is approved, and can be marketed to the consuming public. Alternatively, a formal petition for a review and FDA issuance of an order prescribing the conditions under which a new dietary ingredient can be used and reasonably be expected to be safe, with the FDA having to respond within 180 days, can be filed. Again, shouldn’t a non-decision on a petition be considered as final Agency approval? If the Agency does not issue a decision either way, or if it cannot find a decision that was issued over the previous seventeen years, has it been the industry or the FDA itself who has not been in compliance with DSHEA? Apparently, the FDA believes that manufacturers and suppliers have not met the FDA’s own self-interpreted DSHEA burden of proof standard to show to the FDA that there is reasonable evidence that supplements and new ingredients in supplements are safe. The NHF believes, based upon the DSHEA law language, that this is a total misapplication of the DSHEA burden-of-proof standard. The burden of proof has been, and is on, the FDA to prove that supplements, which they have de facto approved through the pre-marketing notification process, are unsafe in the post-marketing stage of consumer use. Since DSHEA, there have been seventeen years of additional historical use-safety experience conducted by many millions of Americans. The FDA is choosing to ignore evidence and is attempting to paint this as non-compliance. In other words, it has not done its job but instead claims that it is not the FDA’s fault – instead, supplement consumers and industry should pay the price. Take Action Now The NHF has created a solution for all of us to rally behind – the Dietary Supplement Protection Act (DSPA) as H.R.3380. Some timid souls in the industry cower in a corner, saying they are afraid to support this bill because it will “open up DSHEA.” In case they had not already realized it, DSHEA gets “opened up” by our anti-health-freedom opponents each and every year with their new legislation! Are we to be nothing but cowards when we have the chance to regain some of our own freedoms? The NHF isn’t and knows that we need to be as bold as, even bolder than, our opponents. Both companies and consumers must support H.R.3380, especially when Congress gets back to work in mid-January 2012. The bill changes a key date in the DSHEA law that will save thousands of our supplements. It does this by acknowledging and using in our favor the new regulatory environment for supplements as well as supplements’ incredible safety record. It will put FDA bureaucrat’s feet to the fire and an end to their seventeen-year efforts to salami-slice the DSHEA law to fit their own public-policy agenda for dietary supplements. Information on H.R.3380 and how to contact your member of Congress to sponsor H.R.3380 is available on the NHF webpage at: http://www.thenhf.com/page.php?id=295. The NHF needs everyone to contact their representatives and urge them to co-sponsor H.R.3380. We need the same consumer outrage that was seen pre-DSHEA to make this legislation a reality. Be bold and be persistent.
******************** Click here for the permanent link to this news release, use this link to inform others. ******************** National Health Federation: Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals’ rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions. The NHF is the only such organization with recognized observer-delegate status at Codex meetings. ******************** Find Us On FaceBook and LinkedIn! If you would like to be removed from this mailing list, click here. P.O. Box 688, Monrovia, CA 91017 USA ~ 1 (626) 357-2181 ~ Fax 1 (626) 303-0642 Website: www.thenhf.com E-mail: contact-us@thenhf.com |
Posted in Big Agriculture, Family Wellness, Food freedom, heart disease, liberation diet, liberation wellness, Nutrition, raw milk, weston price | Tagged: Dietary supplement, fda, Food & Drug Administration, National Health Federation, Natural Products Association, NHF, Press release, United States | Leave a Comment »
Raw Milk Freedom Riders
Posted by Kevin Brown on November 29, 2011
Mothers, Acting As ‘Agents,’ To Defy FDA Warning

Mothers, Acting As ‘Agents,’ To Defy FDA Warning
Against FDA Prohibitions, Freedom Riders Will Publicly
Distribute over 100 gallons Raw Milk to Waiting Mothers
Chicago, IL—On December 8, a group of mothers and others will defy the U.S. Food and Drug Administration’s (FDA) ban on “distributing” fresh milk across state lines by transporting 100 gallons of raw milk from Wisconsin to Chicago’s Independence Park and distributing it to customers waiting at the park. Rally time is 11:30am – 2:00pm.
Federal law 21 CFR § 1240.61 prohibits interstate movement and distribution of raw milk for human cons
umption. The FDA regulation applies to individuals, or “agents” acting on their behalf.
Over the past year, the FDA and state authorities have conducted undercover sting operations on, raided and prosecuted farmers, buying clubs, and individuals who help distribute raw milk and other farm fresh foods. Over a dozen people and businesses currently face charges, orders, and other enforcement actions; some are under “federal criminal investigation” and face possible indictment by a grand jury. Several small cheese producing dairies with no history of making anyone sick have been put out of business by the FDA’s actions.
“It is a God-given, inalienable right to engage in direct, private transactions with our food producers,” says Max Kane, director of a Chicago area local-food-buying club. “Americans deserve to know that the FDA is using their tax dollars to target and prosecute independent, peaceful, farmers and their customers.”
Mothers from around the country, determined to protect their families’ food supply, launched the Raw Milk Freedom Riders with an inaugural ride on November 1 when they transported raw milk from Pennsylvania to the FDA’s headquarters in Silver Spring, Maryland, and distributed the milk to crowds gathered for a protest. In response the FDA issued a statement saying it does not “intend” to take “enforcement action against an individual who purchased and transported raw milk across state lines solely for his or her own personal consumption.”
The Freedom Riders say that the FDA’s statement leaves the door open for FDA to pursue farmers, buying clubs and individuals acting as “distribution agents.” The Wisconsin to Chicago Raw Milk Freedom ride will challenge the FDA’s use of force against raw milk distribution.
Media are invited to ride along as embedded reporters to witness the FDA’s reaction to the Freedom Riders’ standing up for their rights.
Info about farm raids www.FarmFoodFreedomCoalition.org For additional information on raw milk www.westonaprice.org
Posted in Big Agriculture, Family Wellness, heart disease, liberation diet, liberation wellness, Nutrition, raw milk, weston price | Tagged: chicago, fda, Food & Drug Administration, Freedom Rides, Pennsylvania, raw milk, United States, Wisconsin | Leave a Comment »
Food Safety
Posted by Kevin Brown on November 25, 2011
FDA CONCEDES RAW MILK ACROSS STATE LINES OK FOR PERSONAL CONSUMPTION
But continues to broadcast misinformation about unpasteurized dairy
Washington, DC ( November 17, 2011)—
In a statement issued on November 1, concurrent with a raw milk freedom rally held outside FDA headquarters in Silver Spring, Maryland, the agency conceded that it “has never taken, nor does it intend to take, enforcement action against an individual who purchased and transported raw milk across state lines solely for his or her own personal consumption” [www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MilkSafety/ucm277854.htm]. This statement reverses FDA‟s prior position in which the agency reserved the option of taking action against individual consumers crossing state lines with raw milk. Federal regulation 21 CFR § 1240.61 prohibits the introduction of raw milk for human consumption into interstate commerce.
A caravan of moms brought raw milk across state lines on November 1 and served it to rally participants in front of FDA headquarters.
“Unfortunately, FDA‟s announcement allowing individuals to transport raw milk across state lines is filled with the same misinformation that the agency has spread in the past,” says Sally Fallon Morell, president of the Weston A. Price Foundation, an organization that sponsors A Campaign for Real Milk, aimed at universal access to clean raw milk. “FDA continues to insist that raw milk is dangerous, when even the agency‟s own exaggerated list of outbreaks shows that raw milk is safer than other foods.”
“FDA lists outbreaks associated with raw cheese, produced in less than sanitary conditions, as „outbreaks caused by raw milk,‟ thereby inflating the number of illnesses associated with raw milk,” says Fallon Morell. “The actual number of illnesses associated (but not necessarily proved) with raw milk is about forty-two per year, which makes raw milk a very safe food given the large number of raw milk consumers. No deaths have been associated with raw milk during the past twelve years, but three people have died from tainted pasteurized milk.”
FDA insists that raw milk drinkers constitute less than 1 percent of the population. Yet a 2007 government survey found that about 3 percent of the population consumes raw milk, or about nine million people. This number is likely to be higher today as raw milk consumption is growing rapidly. Even in the state of Maryland, where raw milk sales are illegal, over 3 percent of respondents stated that they drank raw milk.
“This milk is coming from Pennsylvania, where raw milk sales are legal,” says Pete Kennedy, president of the Farm-to-Consumer Legal Defense Fund, “to the great detriment of Maryland farmers.” According to Kennedy, hundreds of thousands of dollars of farm sales each year flow from Maryland to Pennsylvania.
The Farm-to-Consumer Legal Defense Fund is currently representing citizens challenging the interstate ban on raw milk in an Iowa federal district court .
According to Fallon Morell, “FDA continues to insist that no science exists to substantiate the nutritional and health benefits of raw milk, yet we now have five European studies, published in peer reviewed journals, showing that raw milk provides powerful protection against asthma and allergies. And there is copious scientific research showing that pasteurization of milk denatures and diminishes the effectiveness of enzymes and vitamins in the milk.”
Moreover, raw milk is designed to build the immune system—the components that do this are denatured by the heat process of pasteurization. FDA claims that the elderly, the immune-compromised, children and pregnant women especially should avoid raw milk. “These are the very people who need it the most,” says Fallon Morell.
The Weston A. Price Foundation is a nutrition education non-profit with 550 local chapters worldwide, and close to 13,000 members. The organization works to educate the public about the health benefits of unprocessed milk from grass-based dairies through its Campaign for Real Milk, http://realmilk.com.
CONTACT: Kimberly Hartke, press@westonaprice.org, 703-860-2711, cell 703-675-5557
URL: http://www.westonaprice.org/press/fda-concedes-raw-milk-across-state-lines-ok-for-personal-consumption
Posted in Big Agriculture, Family Wellness, Food freedom, heart disease, liberation diet, liberation wellness, Nutrition, raw milk, weston price | Tagged: fda, Food & Drug Administration, Maryland, Pennsylvania, raw milk, Silver Spring Maryland, Washington D.C, Weston Price Foundation | Leave a Comment »
Freedom Riders
Posted by Kevin Brown on November 25, 2011
Raw Milk Freedom Riders to Ride Again
December 8th 2011 IN CHICAGO!
more info at RawMilkFreedomRiders.com
You are invited to join the Raw Milk Freedom Riders, Food Freedom Advocates from around th
e country, local and national press and Maybe the FDA and law enforcement* at our next Freedom Ride coming to Chicago IL.
Who: Raw Milk Freedom Riders and Speakers from around the U.S.
What: 100 gallons of Raw Milk and Cookies to be distributed in support of Food Freedom
Where: From Wisconsin to Chicago. Rally at Independence Park, 3850 West Irving Park Road, Chicago, IL. 60618
When: Thursday, December 8, 2011 (11:30am-2:00pm)
Why: After the first freedom Ride on November 1st in Maryland, the FDA issued a statement saying, in part, they did not “intend” to target individuals transporting raw milk across state lines for their own, individual use. Implicit in this, FDA is admitting their intent to criminally target agents, buying clubs, coops and farmers in their pursuit of raw milk prohibition.
Join us as we call for an end to the prohibition and criminalization of raw milk consumers!
______________________________________________________________________________
The caravan of Freedom Riders will include embedded reporters to broadcast what we are doing and why—to shed light on the FDA’s violent and failing policies. We are informing the FDA of our intentions and inviting them to the party as we caravan over 100 gallons of raw milk from Wisconsin and then distribute in Chicago at Independence Park. It is time to challenge the FDA on the law that turns honest parents and farmers into criminals for transporting raw milk across state lines.
Food Freedom heroes Max Kane, David Gumpert, Liz Reitzig, Kathy Pirtle, John Moody, Jim Marlowe and many others dedicated to raw milk choice and food freedom will join us for a rally and peaceful demonstration at Independence Park in Chicago.
We welcome EVERYONE to join us at the rally and help make a HUGE statement to the FDA on our movement toward personal choice, dietary privacy, and food freedom! Please email questions to the Freedom Riders at rawmilkfreedomriders@gmail.com
For additional information, see www.RawMilkFreedomRiders.com
Posted in Big Agriculture, Family Wellness, Food freedom, heart disease, liberation diet, liberation wellness, Nutrition, raw milk, weston price | Tagged: chicago, fda, Food & Drug Administration, Independence Park, Maryland, raw milk, United States, Wisconsin | Leave a Comment »
Raw Milk Freedom Riders Ride Again!
Posted by Liz Reitzig on November 18, 2011
After a hugely successful freedom ride from Pennsylvania to Maryland, here come the Raw Milk Freedom Riders Chicago!
The Freedom Rides are organized, in part by the Farm Food Freedom Coalition.
Posted in Events, FDA, Food freedom, liz reitzig | Tagged: Farm Food Freedom Coalition, fda, liz reitzig, Max Kane, raw milk, Raw Milk Freedom Riders | Leave a Comment »
Raw Milk Freedom Riders!!
Posted by Liz Reitzig on November 6, 2011
Here is the video from one of our embedded reporters, Adam Kokesh and a true American Hero!
Posted in Uncategorized | Tagged: Adak Kokesh, Farm Food Freedom Coalition, fda, liz reitzig, raw milk, Raw Milk Freedom Riders | Leave a Comment »
Milk And Cookies
Posted by Kevin Brown on November 1, 2011
Milk and Cookies Could Get Moms Arrested
Mothers to Break Federal Raw Milk Transport Ban
Washington DC – The beloved American tradition of milk and cookies is a crime for some mothers, according to the Farm Food Freedom Coalition, organizers of a planned civil disobedience on November 1. A US Food and Drug Administration (FDA) regulation makes the transport of raw milk intended for human consumption across state lines illegal, even for individuals purchasing it legally in one state and carrying it into the states where they live.
On Tuesday, November 1, 2011, a group of moms will challenge the FDAs ban on interstate transport of raw milk by picking up fresh milk in Pennsylvania, transporting it to Maryland, then distributing it, along with cookies, in front of FDA headquarters in Silver Spring, Maryland at a rally from 12:00 -3:00pm.
After numerous armed federal assaults and undercover investigations on farmers, coops and buying groups that supply their raw milk, mothers across the country are disgusted with the FDAs aggression and ready to take action to protect their families food.
By criminalizing me for the food choices I make for my family, the FDA is effectively saying that I have no right to feed my family what I, as the parent, know is best for them, says Suzy Provine, one of the raw milk freedom riders who chooses fresh milk for her family. It is one thing to inform me about my choices, but the FDA goes too far by forcing what they think is best on my family.
The FDA is disrupting thousands of families’ food supplies by pressuring states to restrict access to raw dairy. States like Wisconsin and California are shutting down family farms by threatening penalties and jail for farmers.
View www.naturalnews.com/033280_FDA_raids_timeline.html for a timeline of FDAs raids on raw milk farmers. Visit www.FarmFoodFreedomCoalition.com for information about the organizers. For more information on raw milk, go to www.westonaprice.org
Posted in Big Agriculture, Family Wellness, Food freedom, heart disease, liberation diet, liberation wellness, Nutrition, raw milk, weston price | Tagged: fda, Food & Drug Administration, Maryland, Pennsylvania, raw milk, Silver Spring Maryland, United States, Wisconsin | Leave a Comment »











































