fda regulations

April 23, 2015 by  
Filed under Health News

keeps2tI think this is yet another shot across the bow of our personal freedoms and choice.  FDA wants to and i suspect will, continue to ramp up regulation of homeopathic medicines of all kinds.  The ruse is that the consumer is ‘harmed’ because they don’t do anything-at least as far as they are concerned.  You see medicines that are natural are not patentable, meaning once proven that one works everyone can join in and make it and sell it.   To prove that a remedy works one must do clinical trials at the cost of millions to prove/disprove the efficacy of the medicine for the intended condition.

So, if you can’t control the medicine, via patents, then you spent millions to prove it works but you can’t control the market via a patent.  This is why Big Pharma wants to discredit in any way possible all natural remedies.  As more people use them, and less use of these pharmaceuticals, it is harder-or at least takes longer to make a profit.

The folks involved in making and offering natural remedies must rely on information and results hundreds and in some cases centuries old.  This is considered anecdotal evidence and not valid.  For those that use them, these herbal remedies and homeopathics do work when taken correctly.  Unfortunately, now the FDA seems to want to limit our access to these medicines.

FDA Set To Ramp Up Regulation of Alternative Health Medicines

April 23, 2015 by  
Filed under Big Pharma

I think this is yet another shot across the bow of our personal freedoms and choice.  FDA wants to and i suspect will, continue to ramp up regulation of homeopathic medicines of all kinds.  The ruse is that the consumer is ‘harmed’ because they don’t do anything-at least as far as they are concerned.  You see medicines that are natural are not patentable, meaning once proven that one works everyone can join in and make it and sell it.   To prove that a remedy works one must do clinical trials at the cost of millions to prove/disprove the efficacy of the medicine for the intended condition.

So, if you can’t control the medicine, via patents, then you spent millions to prove it works but you can’t control the market via a patent.  This is why Big Pharma wants to discredit in any way possible all natural remedies.  As more people use them, and less use of these pharmaceuticals, it is harder-or at least takes longer to make a profit.

The folks involved in making and offering natural remedies must rely on information and results hundreds and in some cases centuries old.  This is considered anecdotal evidence and not valid.  For those that use them, these herbal remedies and homeopathics do work when taken correctly.  Unfortunately, now the FDA seems to want to limit our access to these medicines.

FDA finally admits over 70% of US chickens are contaminated with arsenic!

January 20, 2015 by  
Filed under Health News

Some industries are apparently scrutinized more by the FDA, like Enerhealth Botanicals, but apparently not the poultry industry!  Click here to find out more.

FDA asks pet owners to check for tainted jerky treats possibly causing animal sickness

March 31, 2014 by  
Filed under Food Watch

WASHINGTON – The Food and Drug Administration is asking pet owners to help them pinpoint why thousands of animals were getting sick from eating jerky treats, mainly manufactured in China.

The agency has spent years trying to find out why 3,600 dogs and 10 cats in the U.S. were sickened by different brands of the treats since the agency first started getting complaints in 2007.

Of the thousands affected, approximately 580 animals died, ABC NEWS reported.

“This is one of the most elusive and mysterious outbreaks we’ve encountered,” says FDA Center for Veterinary Medicine Director Bernadette Dunham. “Our beloved four-legged companions deserve our best effort, and we are giving it.”

Full Article

Report: FDA allowed antibiotics in animal feed despite human health risks

January 29, 2014 by  
Filed under Farming

The U.S. Food and Drug Administration allowed dozens of antibiotics used in animal feed to stay on the market despite findings by its own researchers that the drugs will likely expose people to antibiotic-resistant infections, according to a report released Monday by an environmental advocacy group.

The FDA reviewed 30 different types of antibiotics that are put into livestock feed and found that 18 of them pose a “high risk” of exposing humans to antibiotic-resistant bacteria through the food supply, the Natural Resources Defense Council said in a report about the FDA’s findings.

The manufacturers of the other 12 drugs didn’t submit enough information to the FDA in order to determine whether they could be safely used in animals without harming humans, but the FDA did not withdraw its approval of any of the antibiotics following its review, according to the NRDC.

“To our knowledge, FDA has taken no action since the reviews to revoke approvals for any of these antibiotic feed additives,” the NRDC’s report said.

Full Article

21 to Drink Coffee? The U.S. FDA announced a plan to investigate and potentially regulate caffeine

May 12, 2013 by  
Filed under Health News

I’d like to tell you about a little utopian community nestled in some faraway mountains where caffeine is heavily regulated. Everyone is 20 percent prettier than average and owns a modest home outright. There is no divorce or attention deficit-hyperactivity disorder. But such a place does not exist to serve as either a model or cautionary tale. A few European countries have moved toward regulation — in Sweden, for example, many grocery stores do not sell energy drinks to people under 15. The United States is not likely to lead the charge into federal regulation tomorrow or next year, but when Michael Taylor, deputy commissioner for foods and veterinary medicine at the Food and Drug Administration, was asked last week, “Is it possible that FDA would set age restrictions for purchase?” he responded:

We have to be practical; enforcing age restrictions would be challenging. For me, the more fundamental questions are whether it is appropriate to use foods that may be inherently attractive and accessible to children as the vehicles to deliver the stimulant caffeine, and whether we should place limits on the amount of caffeine in certain products.

Taylor’s comment came in the context of the FDA’s announcement that, as the organization put it, “in response to a trend in which caffeine is being added to a growing number of products, the agency will investigate the safety of caffeine in food products, particularly its effects on children and adolescents.” It’s a kind of nonchalant way to say that the organization in charge of making sure everything we eat and drink is safe for us is, decades into the mass marketing and sale of heavily caffeinated products without regulation to all U.S. markets, going to look into their safety.

Full Article

Food Manufacturers are Fraudulently Diluting High-Quality Food with Inferior Quality Junk

February 5, 2013 by  
Filed under Food Watch

In a predictable trend, food manufacturers are fraudulently diluting high-quality food with inferior quality items.

As ABC News reports:

A new scientific examination by the non-profit food fraud detectives the U.S. Pharmacopeial Convention (USP), discovered rising numbers of fake ingredients in products from olive oil to spices to fruit juice.

“Food products are not always what they purport to be,” Markus Lipp, senior director for Food Standards for the independent lab in Maryland, told ABC News.

In a new database to be released Wednesday, and obtained exclusively by ABC News today, USP warns consumers, the FDA and manufacturers that the amount of food fraud they found is up by 60 percent this year.

In addition, 70% of all ground beef  was found to contain “pink slime”.

Butchers use “meat glue” to create “bigger” cuts of beef, chicken, lamb and fish, even though it leads to much higher levels of food poisoning:

Full Article

U.S. bans import of Canadian meds by individuals

May 31, 2012 by  
Filed under Big Pharma, Health News

The U.S. House of Representatives just passed a bill that would ban Americans from bringing safe, approved Canadian prescription drugs into the country.

H.R. 5651 — the Food and Drug Administration Reform Act of 2012 — was passed Wednesday by a vote of 387-5.

Among other things, it gives the FDA new authority to prevent drug shortages and speed reviews of medical devices. The bill also addresses the matter of drugs imported from abroad, including those deemed safe by Health Canada.

When the Senate debated the bill last week, former presidential candidate and senator from Arizona, John McCain, wanted an amendment that would allow individual Americans to bring in prescription drugs under certain conditions.

Amendment 2107, Safe and Affordable Drugs from Canada, would have permitted the import of drugs that were: Purchased from a licensed pharmacist, from an approved pharmacy in Canada; purchased for personal use; issued by a doctor licensed to practice in the U.S.; and has the same specifications as a drug approved by the FDA.

His amendment was struck down 54-43.

Full Article

Feds shut down Amish farm for selling fresh milk

February 13, 2012 by  
Filed under Food Watch

The FDA has won its two-year fight to shut down an Amish farmer who was selling fresh, raw milk to eager consumers in the Washington region, after a judge this month banned Daniel Allgyer from selling his milk across state lines, and he told his customers he’ll shut his farm down altogether.

The decision has enraged Mr. Allgyer’s supporters, some of whom have been buying from him for six years and who say the government is interfering with their parental rights to feed their children. But the Food and Drug Administration, which launched a full investigation complete with a 5 a.m. surprise inspection and a straw-purchase sting operation against Mr. Allgyer’s Rainbow Acres Farm, near Lancaster, said unpasteurized milk is unsafe and said it was exercising its due authority to stop its sale from one state to another.

Adding to Mr. Allgyer’s troubles, Judge Lawrence F. Stengel said if he is found to violate the law again he will have to pay the FDA’s costs for investigating and prosecuting him.

His customers are wary of talking publicly, fearing the FDA will come after them.

“I can’t believe in 2012 the federal government is raiding Amish farmers at gunpoint all over a basic human right to eat natural food,” said one, who asked not to be named but who got weekly shipments of eggs, milk, honey and butter from Rainbow Acres. “In Maryland, they force taxpayers to pay for abortions, but God forbid we want the same milk our grandparents drank.”

Full Article

Some senators are fighting the FDA for our supplements too. Let’s get active!

January 4, 2012 by  
Filed under Commentary

As the FDA continues its apparent goal to stymie access to supplements several senators have shown themselves to be on our side. We must all get active to keep our access free and unfettered.

Will it be enough to rein in FDA’s outrageous power grab?

ANH-USA, together with a number of supplement trade organizations, went to Capitol Hill to plead our case about the FDA’s profoundly flawed NDI (new supplement) draft guidance in the offices of two powerful senators and longtime friends of natural health, Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT). Our visit was preceded by all the letters you have been sending to Congress, which have immeasurably increased the visibility of this issue. As you know, if this draft guidance stands, it would allow FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. Immediately after this meeting, Sens. Harkin and Hatch wrote to FDA Commissioner Margaret Hamburg and formally asked the FDA to withdraw its guidance document.

The senators urged FDA to begin work on a new draft that provides needed clarification on what constitutes a New Dietary Ingredient (NDI)—but, in their words, does not undermine Congress’s desire to provide consumers with access to safe, affordable dietary supplement products. Exactly!

These senators were uniquely qualified to make such a request, since they were the principal authors of DSHEA, the Dietary Supplement Health and Education Act of 1994. “When Congress included language in the Food Safety Modernization Act (FSMA) directing FDA to clarify when a dietary supplement ingredient is a new dietary ingredient, the expectation was that the guidance would be consistent with DSHEA,” they write. “Unfortunately, the draft guidance serves to undermine DSHEA in a number of important respects.”

They go on to outline the various arguments that we have been making in these pages for some time:

* The requirement for a manufacturer to submit an NDI notification for every dietary supplement containing an NDI is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI;
* This new requirement is burdensome and would impose substantial additional costs on manufacturers, would not provide additional safety benefits, and would undermine access to the safe, affordable nutritional supplements that DSHEA was designed to ensure;
* The NDI guidance’s assertion that synthetic copies of ingredients can never be a dietary ingredient is without any statutory basis, and is contrary to longstanding FDA policy; and
* This guidance is contrary to Congressional intent by grandfathering in only ingredients that were marketed before the enactment of DSHEA—such an argument is particularly specious since “the term dietary supplement wasn’t even defined prior to DSHEA”!

The senators requested that FDA meet with interested parties to work through all of the issues raised in our and others’ comments. Fortunately, FDA can’t just ignore the senators’ request, because the agency is required to work within legislative intent. Otherwise they would be creating new law—which legally they cannot do. This is one of the arguments we have been making all along—that FDA is in fact making new law with this draft guidance, and now Congress is calling them on it!

We would like to thank Senators Harkin and Hatch for being such stalwart champions of natural health, and for their leadership in this battle to prevent the FDA from usurping powers that they are not legally entitled to. We also want to thank every one of you for contacting Congress and the FDA and being such a vital part of this process.

We aren’t out of the woods yet—we’ll have another update soon with additional action items for you. The time may come for more specific legislative action, and we may find ourselves battling FDA in the courts as well. That’s why your continued support and activism is so terribly important. Together we can win this one, preserve your access to supplements, and keep supplements from costing as much as drugs.

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