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We believe that

because life is about choice The fact that nicotine replacement therapy (NRT) is not subsidised more broadly is an unfortunate anomaly. The very limited current subsidy is inconsistent with the recommendations of expert guidelines, and does not correspond with practice in countries such as New Zealand, the United Kingdom and the United States. It is imperative that this anomaly be rectified as soon as possible because enhanced tobacco control programs are likely to be implemented in Australia in 2010. Proposals by the Preventative Health Taskforce for intensive anti-smoking media campaigns and tobacco tax increases are receiving serious, sympathetic consideration by government. Media campaigns and tax increases will prompt more smokers to attempt to quit, but their attempts will be thwarted by a lack of affordable access to the full range of effective, cost-effective smoking cessation pharmacotherapies, in particular because smoking is now strongly associated with low socioeconomic status. The National Prescribing Service recommends NRT as first-line therapy for smoking cessation and other expert guidelines recommend that the choice of pharmacotherapy be based on clinical factors and patient preference. None of the expert guidelines recommend any one pharmacotherapy over another.

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The smoking cessation pharmacotherapies currently PBS-subsidised (bupropion and varenicline) are not suitable for all smokers. The cost of a four-week course of nicotine patches, purchased OTC in a pharmacy or from a grocery store is at least $100, and can be as high as $140, and the smallest available pack of nicotine patches costs two to three times as much as a pack of cigarettes. The price of NRT is a major deterrent to its use by people with low incomes.

J&J & The FDA The FDA resolution on electronic cigarettes The FDA statement Iâ&#x20AC;&#x2122;m confused - What will the FDA do next? Will the FDA impliment category controls?

summary

â&#x20AC;&#x153;The FDA

resolution on electronic cigarettes

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summary

The FDA resolution on electronic cigarettes On Monday, April 25, 2011, FDA announced in a letter to stakeholders that it will not appeal the recent decision by the U.S. Court of Appeals for the D.C. Circuit in Sottera, Inc. v. Food & Drug Administration, stating that e-cigarettes and other products are not drugs/devices unless they are marketed for therapeutic purposes, but that products “made or derived from tobacco” can be regulated as “tobacco products” under the FD&C Act. FDA is aware that certain products made or derived from tobacco, such as electronic cigarettes, are not currently subject to pre-market review requirements of the Family Smoking Prevention and Tobacco Control Act. FDA is developing a strategy to regulate this emerging class of products as tobacco products under the Family Smoking Prevention and Tobacco Control Act. Products that are marketed for therapeutic purposes will continue to be regulated as drugs and/or devices.

source: http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm

full article

“The FDA

statement

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full article The FDA Statement April 25, 2011 Dear Stakeholder: The purpose of this letter is to provide stakeholders and the public with information, in light of a recent court decision, regarding the regulation of products made or derived from tobacco. The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), was enacted on June 22, 2009, and it provides the Food and Drug Administration (FDA) with authority to regulate “tobacco products.” The FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the FD&C Act. Under the FD&C Act, the definition of “drug” includes articles intended: (1) for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or (2) to affect the structure or any function of the body. Similarly, “device” is defined to include articles intended: (1) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body. Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court. The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes. The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera. Under the Tobacco Control Act, “tobacco products” are subject to a number of controls. Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). FDA has already issued a draft guidance that addresses the status of such products.

Moreover, Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions. Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to premarket review. Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.” FDA plans to take the following steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco after the Sottera decision:

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The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

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The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.

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Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize. “Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”

We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health. Sincerely, Lawrence R. Deyton, M.S.P.H., M.D. Director Center for Tobacco Products Janet Woodcock, M.D. Director Center for Drug Evaluation and Research

source: Source: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm

observation

“I’m confused,

what will the FDA do next?

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observation

I’m confused, what will the FDA do next? Today the FDA are forming guidelines on how electronic cigarettes should be regulated, although there are elements of uncertainty surrounding proposed guidelines, through our correspondence with the FDA new regulations shall emerge in 2011. As stated by the FDA in April, early analysis highlights three areas of regulation which may form the basis of FDA regulations;

FDA plan to regulate electronic cigarettes under ‘Family Smoking Prevention’ &‘Tobacco Control Act’. Currently it is unclear if all/part of the aforementioned controls shall be exercised.

FDA may restrict marketing of electronic cigarettes in combination or association with drugs & medicinal products. . This indicates the FDAs aspiration to segregate the marketing of electronic cigarettes as medicinal products, but may not rule out scientific research and studies being conducted by vendors that may support electronic cigarettes as suitable NRT product for the future.

The FDA may not allow any “therapeutic” claims provided by electronic cigarette vendors. A sensible approach by the FDA, several electronic cigarette companies who continually support claims without the use of conclusive scientific research will come under the FDA hammer. Claims and brand names such as; enjoy, fun flavors, quit smoking maybe under close scrutiny by the FDA..

anticipations

â&#x20AC;&#x153;Will the FDA implement category controls?

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anticipations

Will the FDA implement category controls? Category controls define the finer regulatory elements to vendors and its customers, whilst the FDA is strategizing we can assume the proposed controls will be split into 5 parts; Registration & listings, GMP, ingredient listings, adulteration provisions, and misbranding provisions.

Registration & Listings Product registration, product listings, and user fees maybe adopted by the FDA to ensure a formal entry of electronic cigarettes into the FDA database. Pending guidelines yet to be released by the FDA, Jasper & Jasper are committed to work with the FDA to ensure it meets registration and listing provisions.

Good Manufacturing Practices The most challenging FDA regulation anticipated is the Good Manufacturing Practices (GMP). Research conducted by J&J at the time of publishing this report concludes; internationally there is no electronic cigarette vendors operating to GMP standards, contrary to this nicotine formulation used by most vendors is being manufactured in Asia to little or non-existent standards. After 14 months of R&D and chemical engineering Jasper & Jasper is the first and only vendor in the world formulating its nicotine in a recognized cGMP facility in Europe.

Ingredient listings Unlike many vendors Jasper & Jasper already lists its ingredients on packaging, amendments which may be required are currently being explored with our FDA counterparts. Once the FDA introduces guidelines particulars are introduced we aim to be in a transparent position ensuring our ingredients list can be seamlessly updated within FDA listings database.

Adulteration Provisions Over the last 3 years the FDA has voiced major concerns over adulterated ingredients used by electronic cigarette vendors. Vendors purchasing nicotine from unregulated sources within Asia, and whereby the FDA have conducted tests and documented ingredients which may not be safe for human consumption had formed the basis of the FDA to pursue legal action. Although the FDA has recently dropped legal campaign, it is a foregone conclusion that the FDA will be rigorous in its approach to safety and sourcing of ingredients. Most of the worldâ&#x20AC;&#x2122;s electronic cigarette vendors are using between 10-20 Chinese ingredients formulated in China, in most cases J&J use less than half of the ingredients used by other vendors and source ALL ingredients from renowned European pharmaceutical manufacturers to pharmaceuticals grad. The consistency and repute of our source of ingredients, backed with formulation manufacturing conducted in European GMP facilities sets Jasper & Jasper apart from the rest of the pack.

Misbranding Provisions Misbranding provision that maybe introduced by the FDA will really shake the electronic cigarette category. Many vendors are using incorrect marketing messages, unethically advertising to various market sectors, issuing baseless claims, and publishing packaging without correctly outlining safety hazards to the consumer. We expect the FDA to immediately weed out these so called rouge traders which should eventually level out to a handful of vendors operating with FDA endorsement in the US. Jasper & Jasper prides itself on delivering arguably the most ethical brand in the world, unlike many of our competitors we have never been scrutinized or targeted by the FDA; on the contrary we have maintained regular contact with our FDA counterparts. Misbranding provisions which maybe set by the FDA do not trouble J&J, in fact we as an organization hope that the FDA look at Jasper & Jasper as a role model to other vendors operating in the US; transparency, safety, understanding and delivering an ethical message to our target market epitomizes Jasper & Jasper as a responsible vendor. Many vendors operating in the US offer flavored products with or without nicotine which can open a can of worms; products with zero nicotine may be sold to non-smokers, flavors attract the young, social smokers/light smokers/non-smokers alike are attracted. Although the sale of flavored products can be financially rewarding Jasper & Jasper have NEVER manufactured flavors even under intense pressure by its distributors in parts of Europe and the Middle East.

Misbranding Provisions We do not use sex, fashion or flavors when selling our products. Many vendor’s operating in the US use; misleading messages, sexy images, images projecting electronic cigarettes as being fashionable/cool accessories, brand names and marketing material extrapolating connotations of electronic cigarettes being enjoyable. With Aprils FDA statement it is clear branding and messaging will be in many ways governed by various tobacco restrictions, using brand naming such as ‘enjoy’ is taboo within the tobacco industry, which begs the question will FDA regulations take this as a breech or will the FDA show leniency? As responsible organizations, consumer safety will be at the top of the list for the FDA, vendors, distributors, and retailers alike, the importance of sourcing the right electronic cigarette vendor amongst 1000’s of vendors will prove to be key. Working with a team of commercial legal advisors Jasper & Jasper products contain child safe packaging, detailed safety labeling/graphics which conform to, and at times exceed FDA expectations. New guidelines may differ to strict measures we currently adopt, as a responsible company we are looking forward to forthcoming guidelines set by the FDA as a positive move to protect consumers against rouge traders.

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because life is about choice

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