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FDA delays ‘other use’ rule for tobacco-derived products

The Food and Drug Administration (FDA) pushed back by one year a rule to clarify when products derived from tobacco face regulation as drugs or combination products.

Initially set to take effect in February, the FDA first delayed implementation by one month and now intends for it to take effect on 19 March 2018. An additional comment period will expire on 19 May 2017. Additional information is available at:

FDA’s New Database on Grandfathered Tobacco Products

Industry group offers additional clarity on resource

Thomas A. Briant

MINNEAPOLIS — Feb. 15, 2007, is an important date in the Family Smoking Prevention and Tobacco Control Act, the law that Congress passed to authorize the U.S. Food and Drug Administration (FDA) to regulate tobacco products. That date is known as the “predicate date” or “grandfather date.” Every tobacco product that was on the market as of Feb. 15, 2007, is grandfathered, which means that special applications do not need to be filed with the FDA to keep those products on the market.

Just last week, the FDA announced that it has included on its website a searchable database to determine whether a tobacco product is grandfathered. Click here to access that database. To use it, type in the tobacco product name, the name of the manufacturer, select the product category from the drop-down list and then click the search button. The search results will inform you if the product is grandfathered.

However, there is some confusion about the completeness and accuracy of the FDA’s grandfathered database. The Coalition of Independent Tobacco Manufacturers of America (CITMA), Richmond, Va., has issued a letter to its members outlining the issues with the FDA grandfathered database and allowed NATO to disseminate the letter.

Specifically, the CITMA letter indicates that a FDA grandfather determination is not required to sell a grandfathered tobacco product and this has resulted in some grandfathered tobacco products not being included in the database. This means the FDA database only includes those tobacco products that were the subject of a voluntary grandfather-determination request submitted to the agency by a manufacturer. In other words, the database does not include those grandfathered tobacco products for which a voluntary grandfather-status application was not submitted. Also, CITMA indicates that the grandfathered database does not include those tobacco products that receive grandfather status through a substantial-equivalency application submitted to the FDA by a manufacturer.

In its letter, CITMA reports that the coalition has requested the FDA to issue a statement clarifying that the grandfathered database does not include all legally marketed, grandfathered tobacco products.

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Cole-Bishop Bill Reintroduced in Congress

By Tobacco Business –

FDA Congress

U.S. Representatives Tom Cole (R-Oklahoma) and Cole Bishop (D-Georgia) reintroduced legislation in Congress in an effort to change the FDA predicate date under the FDA tobacco regulations. Known as the FDA Deeming Clarification Act of 2017 (HR 1136), this legislation would also adopt new regulations relating to e-cigarette and vapor products. HR 1136 is an updated version of HR 2058 and the Cole/Bishop amendment.

The re-introduced bill would change the predicate date from Feb. 15, 2007 to Aug. 8, 2016, the date when the FDA deeming regulations took effect.

This move would allow newly deemed tobacco products that were on the market as of Aug. 8, 2016-including e-cigarettes, vapor, cigars, pipe tobacco, hookah tobacco, nicotine gels and dissolvable nicotine products-would not need a special Substantial Equivalency Application or Pre-Market Tobacco Application to be filed with the FDA in order to remain on store shelves and in the market. These products would still be required to comply with the other FDA tobacco regulations, however.

Specifically for vapor products, the bill would also establish a product standard for vapor product batteries. The product standard would include technical characteristics that batteries for vapor products would need to meet in order to be used in an e-cigarette or vapor product. Vapor product manufacturers, wholesalers, and retailers would not be allowed to advertise a vapor product in a newspaper, magazine, periodical or other publication except an adult publication whose readers younger than 18 years old constitute no more than 15 percent of the total readership and fewer than 2 million people younger than 18 years older.

This bill would have a major impact on various part of the tobacco industry. First, it would relieve some of the burden placed on manufacturers of varying ages and sizes. Companies founded after Feb. 15, 2007 would be able to continue operating with their products readily available in the market. As is, compliance costs could drive many newer manufacturers out of business. Second, changing the predicate date would give many manufacturers more product on the market. This also could drastically change the course of the vapor industry, much of which was established long after 2007. The vapor industry is also greatly founded in technology and the ongoing improvement and development of said technology. Anything that was on the market prior to the 2007 predicate date, which is very little, would likely not be promoted or used by vapor consumers today. There are also a great deal of questions and concerns regarding the FDA approval process for tobacco products like cigars, pipe tobacco and vapor products, which is likely to be a very long, costly and confusing process.

Many in the vapor industry view HR 1136 as the first necessary step in developing appropriate regulation for the vapor industry. On its website, the Consumer Advocates for Smoke Free Alternative Association (CASAA) commented, “Different efforts and strategies are required to keep moving the ball forward. Looking to the future, fair regulatory treatment of vapor products is part of the larger campaign to change the tobacco control culture int he United States. Ultimately, policy makers, regulators, and public health advocates must change their abstinence-only approach to one of the comprehensive harm reduction in order to humanely reduce the morbidity and mortality associated with smoking cigarettes.”

The passing of HR 1136 would be a major breakthrough for those hit by the FDA deeming ruling. You are encouraged to reach out to your state representatives and voice your support for the bill, either through email, phone or attending a town hall meeting.

Trump’s Administration on the FDA Regulating Cigars

President Donald Trump and his administration are about to get busy in the coming months. The present administration is expected to review the regulatory powers of the Food and Drug Administration of the United States over tobacco products.

The Daily Caller reports that organizations like the Campaign for Tobacco Free Kids and the Robert Wood Johnson Foundation are petitioning the FDA with its programs to discourage young people from smoking pipes and cigars. The group sees the idea of the government arm of paying up to $25 per cigar as absurd.

Last year, the FDA announced that its plans to regulate tobacco products and e-cigarettes did not push through in August because of injunctions filed by tobacco organizations against the FDA and the Department of Health and Human Services in July 2016. The additional regulations aim to prohibit walk-in humidors in stores, ban colorful and artistic labels on cigars and cigar boxes and will require pipe shop owners to secure a manufacturer’s license prior to taking bulk tobacco orders.

The H.R. 563, known as the Traditional Cigar Manufacturing and Small Business Preservation Act of 2017, when taken into effect will override the FDA’s regulations for cigars and was originally sponsored by Congressman Bill Posey and Florida Democrat Kathy Castor.

Forbes reports that Trump’s views against regulations and how they hamper the U.S. economy is backed up in his First 100 Days of Action Plan where is plans on cutting the red tape at the FDA. The Family Smoking Prevention and Tobacco Control Act that was signed by former U.S President Barack Obama gave the FDA the regulatory powers over tobacco products.

The new President’s move against or in favor of new and existing policies in the administration is now creating speculations not only in the FDA issue but as well as in healthcare. Trump has been very expressive against the Affordable Care Act and has pledged that an appeal to Congress will be in the works once he is elected.

Modifications of his stance on these issues and how far he will deconstruct existing policies is what the nation awaits.

Anti-Tobacco Groups Worried About Trump, Congress

Lawmakers considering efforts to weaken FDA’s regulatory power

The federal government and most states continued to receive mostly failing grades from the American Lung Association (ALA) for efforts to reduce tobacco use among adults and teens during 2016, despite the enactment of the long-awaited “deeming” rule giving FDA regulatory authority over all tobacco products, including e-cigarettes and cigars.

The failure to require graphic warning labels on cigarette packaging and to move toward banning menthol cigarettes earned federal administrators and lawmakers an “F” grade from the ALA for tobacco regulation, according to the group’s annual State of Tobacco Control report, released late this week.

But despite these shortcomings, anti-tobacco advocates who spoke to MedPage Today say there is no question that regulatory and other actions taken at the state and federal level during the Obama administration’s 8-year tenure helped spur the record decline in tobacco use among adults and teens.

And they expressed concern that many of these hard-fought gains will be rolled back by the new administration and Congress.

“There is no question that what government does makes a big difference,” Matthew L. Myers of Campaign for Tobacco-Free Kids told MedPage Today.

“During the last eight years we have seen tobacco advertising restricted through the FDA, there have been sustained (anti-tobacco) mass media campaigns, tobacco taxes have increased and internet sales have been curtailed. All of these things contributed to the dramatic decline in tobacco consumption,” Myers asserted.

Speaking with a group of corporate leaders on Monday, President Trump vowed to do away with 75% or more of government regulations and he repeated his campaign promise of massive tax cuts.

Myers said Trump’s views on specific tobacco regulations and taxes are not known.

“President Trump has not spoken about this, so it is still unclear what position he will personally take,” Myers said. “To date, the physical manifestation of our concern comes from the cigarette and e-cigarette industries urging Congress to curtail funding for successful mass media campaigns and critical regulatory measures.”

The ALA’s Erika Seward said two specific attempts now before Congress to weaken FDA’s regulatory authority over tobacco are of particular concern.

On Jan. 13, Rep. Bill Posey (R-Fla.) reintroduced a bill in the House to exempt premium cigars from FDA regulation. The agency’s deeming rule announced last May extended its authority to cigars, e-cigarettes, pipe tobacco, and hookah. Posey first introduced the legislation in 2015, but it failed to pass under the previous Congress.

Congress is also considering legislation to grandfather flavored e-cigarettes and other non-traditional cigarette tobacco products, which would allow them to stay on the market.

“This is especially troubling because the Surgeon General has found that these flavors are particularly attractive to kids,” Seward said, noting that flavorings are believed to be a major driver of the more than 10-fold increase in e-cigarette use among high school-age kids between 2011 and 2015.

She added that there is “real concern about what lies ahead for reducing tobacco use and, specifically, whether the FDA’s existing authority will be weakened.”

While President Trump has not yet named a new FDA director, past actions by his pick for Health and Human Services (HHS) secretary have not lessened this fear.

Rep. Tom Price, MD (R-Ga.), was one of the few members of Congress to vote against giving FDA authority over tobacco, and he also voted against continuation of the Children’s Health Insurance Program (CHIP), which is largely funded by tobacco taxes.

As head of HHS, Price would have authority over the FDA, the CDC, the National Institutes of Health, and other major health agencies.

Myers said lobbyists from the e-cigarette industry are working to convince lawmakers to effectively prevent the FDA from regulating the products, as are groups that oppose government regulation on ideological grounds.

On Jan. 17, a coalition of a dozen free-market and anti-tax activist groups opposed to e-cigarette regulation, including FreedomWorks and Campaign for Liberty, sent a letter to Congress urging that all products on the market before the regulations went into effect last August be exempt from key provisions of FDA oversight, arguing that regulation “is depriving smokers of a demonstrably safer alternative (to traditional cigarettes).”

“While everyone’s focus seems to be on the White House, the tobacco industry has made it clear that it intends to urge Congress to dramatically curtail what has been working to reduce tobacco use,” Myers said.”It may feel like we’ve been back this year for a really long time, but it’s still early.”

There’s Nothing Sexy About An E-Cigarette Exploding In Your Face

Rob Waters ,


I write about health, science and our crazy healthcare system.

Opinions expressed by Forbes Contributors are their own.

The last time I wrote about electronic cigarettes in this space, the post generated about as many comments as I’ve received from any piece (with the possible exception of the hate mail I got when I wrote about the need to permit federal funding for research looking at gun violence). The commenters called me a liar, an idiot and…well, you get the idea.

In that earlier post, I noted that e-cigarette marketers were peddling their products as cool and sexy. The ads are full of women with bare shoulders or in slinky blue satin who “smoke in style” (as an ad for blu e-cigarettes exclaims), while dangling their devices. Now, the continuing spate of news about e-cigs blowing up in the faces or pockets of users made me wonder what a new set of anti-e-cigarette commercials might look like. (Note to California Dept. of Public Health: there’s an idea for you here.)

E-cigarette devices have burst into flames in people’s pockets, blown up in their mouths or exploded while charging. Videos of them starting a fire from the pocket of a Fresno, California, bus rider or in a Leeds, England, market are now making the rounds on the Internet.

But this is no laughing matter.

Earlier this month, the Food and Drug Administration announced it is investigating the dangers of “battery-operated nicotine-delivery devices” as they clinically, but accurately, refer to e-cigarettes. The agency has documented 134 incidents of e-cigarette batteries overheating, exploding or catching fire.

The FDA will hold a two-day public workshop to discuss safety issues surrounding the batteries used in e-cigarettes on April 19 and April 20, 2017, that scientists and members of the public are invited to attend. Some wonder why it took so long.

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products

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The U.S. Food and Drug Administration is probing the dangers of exploding batteries in e-cigarettes, following dozens of reports of devices that have combusted, overheated or caught fire. The agency announced a two-day public meeting for April. The Associated Press reported last month that 66 explosions were identified by the FDA in 2015 and early 2016.

Electronic cigarettes are battery-powered devices made to mimic traditional cigarettes. They are often shaped like cigarettes or pipes, and work by heating a nicotine mixture called “e-liquid,” “e-juice,” or “vape juice.” E-cigarettes are now a $7 billion global industry made up of roughly 500 brands. However, due to a rash of e-cigarette explosions caused by volatile lithium-ion batteries, many consumers are now filing lawsuits against e-cigarette companies, seeking relief for physical, emotional and financial injuries. Dozens of lawsuits allege serious injuries caused by exploding batteries.

The most common injuries suffered by vapers are lung-related but e-cigarettes are exploding with greater and greater frequency and many vapers have suffered burns, scars, and even amputated fingers. Four New Jersey residents, including two teenagers, who suffered third-degree burns when their e-cigarette batteries ignited are suing the shops that sold the “defective” devices. In October 2015, a California jury awarded Jennifer Ries US$1.9 million after Ms. Ries suffered second degree burns from an exploding e-cig battery.

The manufacturers of the lithium ion batteries that power the vaping devices are also the targets of the litigation although the attorneys acknowledged it would be tougher to hold them accountable. The batteries are made in China.

The safety of E-cigarettes has not been extensively studied and there’s no scientific consensus on whether they help reduce rates of cigarette smoking. Last year the FDA announced it would begin to regulate the fast-growing industry, requiring makers of e-cigarettes to submit their devices and ingredients for review for the first time.

FDA probes dangers of exploding e-cigarette batteries

The U.S. Food and Drug Administration is probing the dangers of exploding batteries in e-cigarettes, following dozens of reports of devices that have combusted, overheated or caught fire and sometimes injured users.

The agency announced a two-day public meeting for April, according to an online posting.

The Associated Press reported last month that 66 explosions were identified by the FDA in 2015 and early 2016.

E-cigarettes are hand-held devices that vaporize liquid nicotine. Their safety has not been extensively studied and there’s no scientific consensus on whether they help reduce rates of cigarette smoking.

Last year the FDA announced it would begin to regulate the fast-growing industry, requiring makers of e-cigarettes to submit their devices and ingredients for review for the first time.

FDA Makes Statements on Synthetic Nicotine

During NICOPURE vs. FDA lawsuit the agency confirms products not made from tobacco are not regulated tobacco products under recent deeming rule.

Next Generation Labs, the makers of proprietary TFN Nicotine – a non-tobacco derived synthetic nicotine liquid and crystals – has noted statements made to the court by the U.S. Food and Drug Administration (FDA) in the Nicopure vs. FDA lawsuit that confirms products not made or derived from tobacco are not regulated tobacco products under the recent Deeming Rule.

In a response brief to the Court dated Nov. 1 2016, the FDA stated that: “Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’ —that is, if it is ‘intended or reasonably expected’ either…(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory.”

The FDA’s Deeming Rule was designed to extend the agency’s regulatory authority over a variety of tobacco products, which greatly impacts the vape industry. However, the recent clarification from FDA attorneys appears to confirm that the Deeming Rule does not extend to e-liquids that are either nicotine-free, or not made or derived from tobacco, when marketed and sold appropriately.

TFN Nicotine is not made or derived from tobacco, nor is it a component or part of any tobacco product; as such Next Generation Labs does not believe e-liquids made with TFN Nicotine are required to list their product as a tobacco product with the FDA, or prepare a Pre-Market Tobacco Application (PMTA) submission before launching a new vape liquid brand in the USA.

Vincent Schuman, CEO of Next Generation Labs, commented: “The FDA’s statements to the Court seem to confirm our long-held position: TFN Nicotine products cannot be regulated under the Deeming Rule as they simply are not tobacco products. In order to comply with the FDA, the onus is on e-liquid manufacturers to consider how their TFN Nicotine product is marketed, distributed and positioned to adult consumers to ensure a complete disassociation from tobacco and tobacco devices.”

In addition to this recent statement, the FDA has also extended the deadline for the registration and product listing requirements of the Deeming Rule, stating: “U.S. manufacturers of newly-regulated tobacco products who first manufactured those products prior to Aug. 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the Aug. 8 effective date of the deeming rule must register and list immediately with the FDA.”