FDA Regulations Could Wipe Out 99 Percent Of E-Cigarette Industry

The e-cigarette industry could be all but wiped out thanks to regulations coming down the pipeline from the Food and Drug Administration.

Most damaging of all, e-cigarette makers will have to retroactively submit marketing applications for all their products, with the costs running into the millions.

Manufacturers of e-cigarettes could also be banned from advertising the reduced risk from substituting smoking for vaping unless they can convince the FDA otherwise.

In 2009, e-cigarettes came under the purview of the FDA and may face many of the restrictions placed on the tobacco industry, such as issuing health warnings and stopping sales to minors.

The e-cig industry is still relatively young, with the first e-cigarette invented in China in 2007. Despite there being close to 20 million Americans regularly using e-cigarettes, the FDA’s regulations could bankrupt the vast majority of producers.

Speaking to The Hill, Jan Verleur, co-founder and CEO of VMR Products, said as much as 99 percent of the industry could be wiped out. “This makes it so any product released after the grandfather date would require premarket approval,” said Verleur.

He added that ”the process could cost us half a million to million dollars,” per individual product. With more than 500 e-cigarette products, VMR Products would have to pay five times the company’s revenue.

His comments echo those of the president of the American Vaping Association Greg Conley who told the L.A. Times Monday that 99 percent of the small businesses in the industry could close their doors.

There is as of yet no fixed date for when the rules come into force. The FDA has said it will give companies two years to submit their applications and they will be able to sell the products under review during that time.

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Originally published by the Daily Caller News Foundation

Via: California Political Review

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Feds Delay Obamacare Menu Labeling Rule By a Year

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Where are calorie counts on menus?

KIRO - Seattle

The Food and Drug Administration (FDA) is delaying an Obamacare regulation requiring restaurants to display calorie information until December 2016 after businesses complained they did not have sufficient time to comply with the complex rules.

The FDA’s rule, which is the latest Obamacare regulation to be delayed, went into detail on whether pumpkin spice muffins should be labeled, but remained vague as to what the definition of a menu is, was set to take effect on Dec. 1.

“The Food and Drug Administration … is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments,” the agency said in a notice to be published in the Federal Register on Friday.

“We are taking this action in response to requests for an extension and for further clarification of the rule’s requirements,” the FDA said.

The 319-page regulation, mandated by Obamacare, is estimated to cost industry $1.7 billion to comply. The rule requires restaurant chains with 20 or more stores to list calorie information for nearly every food item, and a “succinct statement” that “2,000 calories a day is used for general nutrition advice, but calorie needs vary,” on each menu board.

Vending machines must also display calorie information, though that part of the regulation was already set to take effect in December 2016.

Violations of the regulation can carry civil and criminal penalties, of up to a $1,000 fine, one year in prison, or both.

Domino’s, a leading critic of the rule claimed that it is “impossible to comply” with its requirements, said the delay is not enough to fix the regulation.

“FDA’s delay confirms both the serious deficiencies in the final rules and the urgent need for enactment of the bipartisan Common Sense Nutrition Disclosure Act (H.R. 2017),” said Lynn Liddle, executive vice president of Domino’s and chair of the American Pizza Community, in a statement. “Unfortunately, FDA proceeded with an approach to final rules that impose significant compliance costs without achieving any meaningful improvements in consumer education.”

“After years of uncertainty, FDA still has not addressed basic questions regarding implementation,” she said.

The proposed legislation, sponsored by House Republican Conference Chairman Cathy McMorris Rodgers (R., Wash.), would give businesses greater flexibility in how to display calorie information. The bill would allow companies where the majority of their orders are carryout and delivery, such as pizza chains, to display the information online.

The Common Sense Nutrition Disclosure Act also clarifies that an advertisement, coupon, flyer, window display, or post on social media is not a menu, which the regulation implied. The rule defined a menu as anything “used by a customer to make an order selection at the time the customer is viewing the writing.”

“The FDA’s self-admission that these regulations are unclear, unpractical, and unworkable is welcome, but a one-year delay doesn’t change the underlying problem on the books—a one-size-fits-all, 400-page regulation that is nearly impossible to follow,” Congresswoman McMorris Rodgers told the Washington Free Beacon. “Providing consumers accurate, clear, consistent nutritional information is everyone’s priority, but it doesn’t have to come at the expense of commonsense.”

The FDA said they received “numerous requests asking us to further interpret portions of the final rule” since it was finalized last year. Businesses asked for more time due to the need to change all of their menus, and train staff.

“The U.S. Food and Drug Administration appreciates and takes very seriously the extensive input it has received from stakeholders throughout the process of establishing requirements for menu labeling in restaurants and other retail food establishments,” FDA Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor said. “The FDA is committed to working collaboratively with those establishments covered by the menu labeling final rule, including chain restaurants, covered grocery stores, and others to facilitate timely and efficient implementation of the new requirements.”

The FDA is still planning to issue a “draft guidance document” to businesses further clarifying the rules and will “provide educational and technical assistance for the covered businesses and for our state, local, and tribal regulatory partners to support reasonable and consistent compliance nationwide.”

Via: WFB

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The ‘Public Health’ Cabal’s War on E-Cigarettes

Ever since the abominable Family Smoking Prevention and Tobacco Control Act, giving oversight over tobacco to the FDA, was passed in 2009, I and many of my colleagues in public health have watched in disbelief and horror as the crusade against e-cigarettes swung into high gear. It seemed for a moment as though the Golden Age had come to pass regarding smoking: the twin goals of FDA regulation and a truly low-risk method of delivering nicotine to addicted smokers without the lethal tar was at hand, at last.

Then the prize slipped through our fingers like sand: the FDA and all of the other federal health agencies (especially the CDC) led a crusade against these disruptive devices, initially trying to simply ban them as drug delivery devices (alongside a propaganda campaign alluding to various toxins in their vapor, all imaginary). When the federal courts blocked that path, the drug agency decided to enforce the Tobacco Control Act in the most stringent manner by promulgating a regulatory schema deeming e-cigs and vapor products as candidates for regulation as tobacco — despite their total lack of that substance. Such over-regulation would effectively ban these products, despite their proven and accelerating popularity among smokers trying to quit. The anti-vaping crusade has since been eagerly joined by most of the academic centers, “public health” nonprofits, and politicians far and wide, ostensibly to “protect our children from Big Tobacco.”

Of course, as soon as your hear a politician chant the “for the children” mantra, get ready to have your pocket picked. And, no surprise, the real motivation behind these campaigns became clear: follow the money. Once that realization came, the whole issue became clear, depressingly so.

Via: American Spectator

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The FDA just banned trans fats — here's what it means for you

In a move that experts say could prevent thousands of deaths every year, the US Food and Drug Administration has declared that trans fats are no longer considered safe in food.

The new rule released Tuesday, June 16 gives food companies three years to cut trans fats from the food supply. And while the use of these fats has already declined a lot in recent years, some companies are slacking on removing it from their products.

About 85% of artificial trans fat has already been removed from the food supply, as a result of an ongoing public health campaign including a requirement to put trans fat on nutrition labels, state and local bans of trans fats in restaurants, and lawsuits, according to the Center for Science in the Public Interest (CSPI).

The newly announced ban, then, is a means of "putting the last nail in the coffin," Jim O’Hara, director of health promotion policy at CSPI, told Business Insider.

Via: Business Insider

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Texas Abortion Law Remains In Effect

Earlier in the month I wrote about the decision of the Fifth Circuit to leave in effect the Texas abortion law that made Wendy Davis modern day priestess of Baal as far as the left is concerned (see The Fifth Circuit Rules In Favor Of Women’s Health and Life):

The bill ultimately passed in a special session and was immediately appealed on two grounds by Planned Parenthood.

They objected on two basic grounds: that the requirement that the abortionist have admitting privileges at a hospital within 30 miles and that the abortionist must be qualified in the field of obstetrics and gynecology, and that any use of the abortion pill be done according the protocol approved by the Food and Drug Administration.

They did not ask for an injunction based on the law requiring abortuaries meet the same physical specifications as urgent care clinics and it did not challenge the law outlawing any abortion after 20 weeks.

Planned Parenthood appealed to the US Supreme Court to overturn the Fifth Circuit ruling pending a hearing in January. Yesterday, Planned Parenthood got the bad news. The Supreme Court upheld the Fifth Circuit and allowed the Texas law to go into effect. The impact is that abortion, for all intents and purposes, is illegal in substantial areas of Texas.

Via: Red State

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Americans’ personal data shared with CIA, IRS, others in security probe BY MARISA TAYLOR

WASHINGTON — U.S. agencies collected and shared the personal information of thousands of Americans in an attempt to root out untrustworthy federal workers that ended up scrutinizing people who had no direct ties to the U.S. government and simply had purchased certain books.

Federal officials gathered the information from the customer records of two men who were under criminal investigation for purportedly teaching people how to pass lie detector tests. The officials then distributed a list of 4,904 people – along with many of their Social Security numbers, addresses and professions – to nearly 30 federal agencies, including the Internal Revenue Service, the CIA, the National Security Agency and the Food and Drug Administration. Although the polygraph-beating techniques are unproven, authorities hoped to find government employees or applicants who might have tried to use them to lie during the tests required for security clearances. Officials with multiple agencies confirmed that they’d checked the names in their databases and planned to retain the list in case any of those named take polygraphs for federal jobs or criminal investigations.

It turned out, however, that many people on the list worked outside the federal government and lived across the country. Among the people whose personal details were collected were nurses, firefighters, police officers and private attorneys, McClatchy learned. Also included: a psychologist, a cancer researcher and employees of Rite Aid, Paramount Pictures, the American Red Cross and Georgetown University.

Via: McClatchy

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Read more here: http://www.mcclatchydc.com/2013/11/14/208438/americans-personal-data-shared.html#storylink=cpy

Rand Paul Warns: FDA Is ‘Coming After Your Doughnuts’

In some of Senator Rand Paul’s (R-KY) first non-plagiarism news in a while, the Kentucky senator warned on Monday that the Federal Drug Administration’s new ban on trans fats was another intrusion by the nanny state, this one aimed at your morning indulgences.

“They’re coming after your doughnuts!” Paul told a crowd at The Charleston Meeting in South Carolina, in addition to taking a shot at New York City Mayor Michael Bloomberg’s attempted soda ban.

“Some unelected bureaucrat has banned trans fat,” he continued. “So I say, we need to line every one of them up. I want to see how skinny or how fat the FDA agents are that are making the rules on this. Not only that, any of them with a BMI over 16, or whatever the number you’re supposed to have, I want to see them on the treadmill, and I want to see someone from OSHA lashing them while they’re working on the treadmill.”

“If we’re going to have a nanny state, and everybody’s gotta eat the right thing, and you can’t eat a doughnut, maybe we ought to enforce it on the government workers first,” Paul said.

New York Magazine columnist Jonathan Chait was quick to rebut Paul’s charges:

They are not, in fact, coming after your doughnuts. Trans fats are not essential to make doughnuts or, really, anything. Some restaurants still use trans fats because, even though they’re incredibly bad for you, they’re longer-lasting and slightly cheaper than other oils, and very few customers would ever know the difference.

Via: Mediaite.com

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FEDS COME AFTER TRANS FAT

Heart-clogging trans fats have been slowly disappearing from grocery aisles and restaurant menus in the last decade. Now, the Food and Drug Administration is finishing the job.

The FDA announced Thursday it will require the food industry to gradually phase out artificial trans fats, saying they are a threat to people's health. Commissioner Margaret Hamburg said the move could prevent 20,000 heart attacks and 7,000 deaths each year.

Hamburg said that while the amount of trans fats in the country's diet has declined dramatically in the last decade, they "remain an area of significant public health concern." The trans fats have long been criticized by nutritionists, and New York City and other local governments have banned them.

The agency isn't yet setting a timeline for the phase-out, but it will collect comments for two months before officials determine how long it will take. Different foods may have different timelines, depending how easy it is to find a substitute.

"We want to do it in a way that doesn't unduly disrupt markets," said Michael Taylor, FDA's deputy commissioner for foods. Still, he says, the food "industry has demonstrated that it is, by and large, feasible to do."

Though they have been removed from many items, the fats are still found in processed foods, including in some microwave popcorns and frozen pizzas, refrigerated doughs, cookies, biscuits and ready-to-use frostings. They are also sometimes used by restaurants that use the fats for frying. Many larger chains have phased them out, but smaller restaurants may still get food containing trans fats from suppliers.

Via: Breitbart

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U.S. Has Cash to Close Memorials, Can’t Afford Enforcing FOIA

The U.S. government can spend money shutting down and barricading memorials around Washington D.C., but it won’t dedicate the necessary resources to obey transparency laws, using the shutdown as an opportunity to ignore the Freedom of Information Act (FOIA).

Without the accountability and transparency that FOIA is meant to provide, the government will essentially operate in secrecy. Nothing, not even a temporary, partisan impasse among lawmakers, should justify a furlough in the enforcement of government transparency laws. But that’s exactly what’s happening, according to the Reporters Committee for Freedom of the Press, a decades-old nonprofit that works to protect journalists’ FOIA rights.

“Parts of the federal government have declared transparency non-essential, deciding requests under the Freedom of Information Act will go unprocessed during the shutdown,” the group says in an announcement posted on its website this week. “Some agencies have indicated they won’t even accept FOIA requests until everything is back to normal and have suspended their websites.”  Additionally, those seeking information from federal agencies should be “prepared for longer than usual delays in receiving the requested records,” the group says.

Among the federal agencies that have officially announced they won’t process FOIA requests during the shutdown are the Central Intelligence Agency (CIA), the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). Others—like the Agriculture, Interior and Transportation departments—have simply disabled their FOIA websites without notifying the public. Some have confirmed “reduced FOIA operations.” They include the National Institutes of Health (NIH), the National Labor Relations Board (NLRB), the Government Information Services and the National Security Administration (NSA).

Even when FOIA is supposedly in full force, stonewalling and unnecessary delays are the norm when requesting public records from the government. Judicial Watch knows this firsthand because FOIA is a valuable tool in our work and JW files dozens of requests with a number of federal agencies every year. Generally the government must respond to a FOIA request within 20 days, though that rarely occurs and JW must take legal action to force compliance.

Just this week JW filed a FOIA request with the Department of the Interior for information related to blocking public access to national monuments in Washington D.C. due to the federal government shutdown. JW also seeks all records related to the cancellation of planned visits by veterans’ groups to the National World War II Memorial due to the shutdown. In the official request JW reminds the agency of a 2009 memorandum issued by President Obama. It states: “All agencies should adopt a presumption in favor of disclosure in order to renew their commitment to the principles embodied in FOIA…The presumption of disclosure should be applied to all decisions involving FOIA.”

Via: Judicial Watch

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FDA REQUIRES TRACKING CODES ON MEDICAL IMPLANTS

Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier.

The Food and Drug Administration published new rules Friday that require most medical devices sold in the U.S. to carry a unique code, identifying its make, manufacture date and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.

The tracking system has been promoted by doctors and public safety advocates for years. Other industries, from food processors to automakers, have used unique identification codes to track their products through the supply chain for decades.

"The rule that came out today is a victory for patients, hospitals and clinicians," said Josh Rising, director of Pew Charitable Trusts' medical device initiative. "Up until now medical devices were among the only products on the market that could not be uniquely identified. This is going to be a tremendous victory for all of those interested in improving the performance of devices."

Rising says doctors, hospitals and insurers will be able to add the codes to patients' medical records, helping them to quickly identify people who have received problematic implants and devices.

The FDA tracking system follows years of highly-publicized recalls involving defibrillators, artificial hips and drug pumps, which have been plagued by design and manufacturing flaws.

Via: Breitbart

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