BREAKING NEWS: FDA Reconsidering Criteria for Raw Milk Cheese

Simply put, this is great news: the FDA has announced that it is reconsidering its safety criteria for the testing of raw milk cheeses. In particular, they have paused testing for non-toxigenic E. coli, a controversial method which many argued failed to correctly assess the real safety profile of raw milk cheeses. This is an important step forward, and the FDA is to be congratulated for it. 

This came about thanks to all the people who have been working so hard, meeting with the FDA, keeping the public informed and the cheese community engaged, and working with lawmakers to arrive at this point. This includes the American Cheese Society, The Cellars at Jasper Hill, the Vermont delegation, including Senator Bernie Sanders, Representative Peter Welch, and Senator Patrick Leahy, and many others. 

Via the FDA

FDA Is Taking a New Look at Criteria for Raw Milk Cheese

February 8, 2016

Recently, cheesemakers have raised concerns suggesting that the FDA is applying safety criteria that may, in effect, limit the production of raw milk cheese without demonstrably benefitting public health.

In response, we want to first acknowledge our respect for the work of the artisan cheesemakers who produce a wide variety of flavorful, high-quality cheeses using raw milk and our appreciation for the great care that many take to produce raw milk cheeses safely. We understand the concerns expressed by some cheesemakers, as well as lawmakers, and intend to engage in a scientific dialogue on these issues.

The agency’s role in this area, and with respect to food safety generally, is to work with the industry, consumers, government partners, and experts to be sure the right science-based, prevention-oriented standards and safety criteria are in place and that there is widespread compliance in the interest of food safety and consumer confidence. Some question testing raw milk cheese for the presence of non-toxigenic E. coli, which has long been used by FDA and other public health agencies in the U.S. and other countries to indicate fecal contamination.  Specifically, the concerns include the application of the test results and scientific foundation of these criteria.

The FDA’s reason for testing cheese samples for non-toxigenic E. coli is that bacteria above a certain level could indicate unsanitary conditions in a processing plant. Our surveillance sampling shows that the vast majority of domestic and imported raw milk cheeses are meeting the established criteria.

The agency will re-evaluate its criteria in the context of the overarching framework for the oversight of food production provided by the 2011 FDA Food Safety Modernization Act (FSMA). The Preventive Controls for Human Food rule mandated by FSMA, which became final in September, requires that food producers identify hazards in their product and operations and put controls in place to prevent or minimize those hazards.

Looking ahead, with the FSMA preventive controls rule now final, we will be taking another look at what role non-toxigenic E. coli should have in identifying and preventing insanitary conditions and food safety hazards for both domestic and foreign cheese producers.

The FDA will also consider and update, as appropriate, the 2010 Compliance Policy Guide, which outlines safety criteria. Any changes will be informed by our engagement with stakeholders and experts on such issues as the use of a single bacterial criterion for both pasteurized and raw milk cheese, and the use of non-toxigenic E. coli as an indicator organism.

The agency will continue to inspect cheese-making facilities and test for pathogens in domestic and imported cheese but, in the meantime, FDA is in the process of pausing its testing program for non-toxigenic E. coli in cheese. We will also continue working with all stakeholders to benefit from their expertise about safe cheese-making practices and achieve the mutual goal of food safety.

The Food and Drug Administration is seeking your input to answer a question: How should the agency define “natural” on food labels?

Disagreement over what “all natural” or “100 percent natural” means has spawned dozens of lawsuits. Consumers have challenged the naturalness of all kinds of food products.

For instance, can a product that contains high fructose corn syrup be labeled as natural? What about products that contain genetically modified ingredients?

What’s ‘Natural’ Food? The Government Isn’t Sure And Wants Your Input

Photo: Tim Boyle/Getty Images

Mr. Shkreli [the CEO of Turing Pharmaceuticals] is one of those regulatory “entrepreneurs” using the power of the state to manipulate things in his favor. It has been alleged his investment fund shorted various pharmaceutical stocks and then filed complaints against the companies with the Federal Drug Administration, thus causing an investigation. The investigation would then negatively impact the price of the stock, and Shkreli would profit … Bloomberg Business reported in 2014, “Shkreli developed a reputation for using a stock-gossip website to savage biotech companies whose shares he was shorting. This was not a path to popularity in biotech. In 2012 the nonprofit Citizens for Responsibility and Ethics in Washington (CREW) publicly accused him of trying to manipulate the U.S. Food and Drug Administration for financial gain. Once again, Shkreli emerged without facing government charges.”
—  James Peron, discussing the overnight price increase of an HIV drug called Daraprim from $1.50 to $750.00 per tablet.

FDA and Greed to Blame for Rising Drug Prices; Not Capitalism

The Pharmaceutical CEO who raised the price of his life saving drug by 5000% has drawn a lot of criticism from media, politicians and the public. But he isn’t a rare example, rather he is just one example of the relationship between pharmaceutical companies and the FDA that has harming consumers.

I’m not the biggest fan of Ben Swann, but he is correct here.  Shkreli might be a terrible businessman, but government regulation is ultimately to blame.
Medical Authority’s System Kills: FDA-Approved Drugs Kill over 100,000 People Annually
Greed, fraud, and corruption within Big Pharma and the FDA are the constructs of deception, with the mantle of authority leading to over 100,000 American deaths each year from correctly prescribed FDA approved pharmaceutical drugs.

“And that doesn’t include those who are sickened, needing more medications from side effects, hospitalization, or years of rehab for crippling adverse “side effects.” Nor does it include the effects from over-the-counter (OTC) drugs that lead to an almost equivalent number of casualties as their prescribed counterparts.“

First-of-its-kind weight loss treatment device.

The US Food and Drug Administration (FDA) has approved a first-of-its-kind weight loss treatment device that electronically suppresses hunger signals traveling between the stomach and the brain.

What is it? The Maestro Rechargeable System is a weight-loss treatment for patients who are morbidly obese or who are obese with one or more obesity-related conditions. It contains some components that are implanted inside the body and some that are outside the body. The internal components include a rechargeable pulse generator (also called a neuroregulator disc) which delivers electrical signals to nerve electrodes. The electrodes are placed on the trunks of the vagus nerve in the abdomen and two electrical leads connect the electrodes to the pulse generator. The external components include a transmit coil, mobile charger, and clinician programmer.

How does it work? The Maestro Rechargeable System delivers small electrical pulses to block transmission of nervous signals in the vagus nerve (vagal blocking therapy, or VBLOC therapy). VBLOC therapy is intended to promote weight loss by suppressing neural communication between the brain and the stomach. The vagus nerve is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full. The precise mechanism of weight loss related to the use of the device is not clear.

When is it used? The Maestro Rechargeable System is intended for people who are at least 18 years old and are obese, with a Body Mass Index (BMI) of 40 to 45 or with a BMI of 35 to 39.9 and one or more obesity-related health condition such as high blood pressure or high cholesterol.

When should it not be used? Patients are not candidates for the Maestro Rechargeable System if they have any of these medical conditions:

  • Cirrhosis of the liver
  • Increased pressure in hepatic veins (portal hypertension)
  • Dilated veins in the esophagus (esophageal varices)
  • Hiatal hernias that are clinically significant and cannot be corrected by surgery.

(To read more).