NAVIGATION
In 2009 the United States Congress completed a long rumored expansion of Title 21. This was manifested via the Family Smoking Prevention and Tobacco Control ACT (Tobacco Control ACT), which was codified into law last year(1). This article will review the purpose of the ACT, reflect on the actions taken in the past year, and discuss future changes yet to be implemented.The expansion to the Act was deemed necessary in light of the dangers to public health and safety posed by tobacco products:
Pertinent Health and Economic Facts Cited by Congress:
- “Tobacco causes over 400,000 deaths in the United States each year, and approximately 8,600,000 Americans have chronic illnesses related to smoking.” (1)
- 3,000-4,000 individuals begin smoking every day and 1,000 will become addicted. (1)
- “Reducing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today’s children from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobacco-induced disease. Such a reduction in youth smoking would also result in approximately $75,000,000,000 in savings attributable to reduced health care costs.” (1)
Advertising’s Effect on Future Use:
- “In 2005, the cigarette manufacturers spent more than $13,000,000,000 to attract new users, retain current users, increase current consumption, and generate favorable long-term attitudes toward smoking and tobacco use.” (1)
- Tobacco product advertising is regularly seen by persons under the age of 18, included in sponsorship of sporting events, and is frequently seen in movies. (1)
- Most people begin smoking as minors and become addicted before the age of 18. More than 80 percent of youth smoke three heavily marketed brands, while only 54 percent of adults, 26 and older, smoke these same brands. (1)
- The National Cancer Institute found that many smokers mistakenly believe that ‘‘low tar’’ and ‘‘light’’ cigarettes cause fewer health problems than other cigarettes even though research demonstrated that these products offer no reduction in health. (1)
The Tobacco Control Act was passed on June 22, 2010. The objectives of the act were twofold:
1) To regulate tobacco products and
2) To mitigate issues of public health and safety concern. (1)
The Tobacco Control Act gives authority to the FDA to treat tobacco manufacturers as drug manufacturers, including the right to:
- set active ingredient standards
- require facility registrations, product approvals and listings
- specify the contents of health warning labels
- set and enforce manufacturing standards and controls
- inspect routine manufacturing and conduct post market surveillance activities, and
- review products that will increase the risk of tobacco use (e.g. additives). (13)
In the previous 12 months, the FDA has completed the following:
1) Created and staffed the Center for Tobacco Products. This program, under the director, Lawrence Deyton, an expert on veterans’ health issues, public health, tobacco use, and a clinical professor of medicine and health policy, will use science to implement public health strategies. (10)
2) Created the tobacco user fee program. (The Center is funded by user fees paid by manufacturers and importers of tobacco products. The user fee program will generate over $4.5 billion in user fees over nine years which is available for FDA tobacco regulation support activities.) (12)
3) Enforced the portion of the law that prevents manufacturing, distributing, and selling certain flavored cigarettes, such as spice-, fruit-, and candy-flavored cigarettes (7). This included taking enforcement actions against manufacturers who continued to distribute flavored cigarettes.
4) Assembled a Tobacco Products Scientific Advisory Committee (TPSAC) that will research various topics and report to Commissioner of Food and Drugs on health and other issues. Currently the group is researching: (3)
- Products that are added to cigarettes that enhance the effects of nicotine in the brain.
- “Studies suggest that additional compounds in tobacco smoke, such as acetaldehyde, may enhance nicotine’s effects on the brain.(3) A number of studies indicate that adolescents are especially vulnerable to these effects and may be more likely than adults to develop an addiction to tobacco.”
- Impact of menthol in cigarettes on the public health.
- On July 15-16, 2010 the TPSAC held a meeting that discussed the effects of menthol on the public health. Speakers from various tobacco companies, (e.g. Philip Morris, R.J. Reynolds and Lorillard) presented their research of menthol and all concluded that menthol had no statistically significant effect on health. (11)
5) Begun processing facility registrations. (13)
6) Assigned authorities to collect the following data from tobacco companies:
- Product lists
- Detailed information about product ingredients and manufacturing processes
- Company’s research into the health effects of their products (1)
7) Requested Philip Morris USA turn over its market research on consumer reaction to labeling changes in the Marlboro Lights product line. (5) The Marlboro Lights brand name was changed to are Marlboro Gold as a result of Title 21s prohibition of using language on labels that implies a lower risk product, unless the lower risk could be clinically proven. (1)
8) Authored the “Draft Guidance on Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.” (15)
9) Authored a document providing guidance to manufacturers on the enforcement policy concerning rotational warning plans for smokeless tobacco products. (14)
10) Authored a guidance document on questions related to the use of ‘light’, ‘mild’, ‘low’ or similar descriptors in the labeling, or advertising of tobacco products. (9)
11) Authored the “Draft Guidance for Industry and FDA Staff: “Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.” (16)
In the previous 12 months, tobacco manufacturers have submitted to the FDA:
- A listing of ingredients and additives that are added to each tobacco product. (1)
- A description of the content, delivery, and form of nicotine in each tobacco product. (1)
- Documents that relate to health, toxicological, behavioral, or physiologic effects of tobacco products, their constituents, ingredients, components, and additives. (1)
- Research activities and findings on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents. (1)
- Research activities and findings that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer. (1)
- Marketing research about tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors. (1)
The specific portions of the law that have become effective in the previous 12 months include:
- The prohibition of any cigarette component from containing any artificial or natural flavoring (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee. (1)
- The prohibition of:
- the sale of cigarettes and smokeless tobacco products to youths younger than 18 and requires photographic age verification to sell these products to individuals 26 years and younger
- the sale of cigarette packages with fewer than 20 cigarettes
- the sale of cigarette packages and smokeless tobacco in vending machines, self-service displays, or other impersonal sales mechanisms, except where no one under the age of 18 is present or permitted
- free samples of cigarettes and smokeless tobacco products, except in adult-only establishments
- tobacco brand-name sponsorship of any athletic, musical or other social or cultural event, or any team or entry in those events
- using a trade or brand name of a non-tobacco product for a cigarette or smokeless tobacco product, unless the name was so used on 1 January 1995
- gifts or other items in exchange for buying cigarettes or smokeless tobacco products
- the sale or distribution of items, such as hats and T-shirts, with tobacco brands or logos but permits sponsorship in a corporate name
- the use of music and sound effects in audio (6)
- the advertising or labeling of tobacco products with the descriptors “light,” “mild,” or “low” or similar descriptors without FDA approval of the label claim (1)
- Require new, larger health warning rotational labels for smokeless tobacco products begin to rotate on labels, such as:
- WARNING: Cigarettes are addictive.
- WARNING: Tobacco smoke can harm your children.
- WARNING: Cigarettes cause fatal lung disease.
- WARNING: Cigarettes cause cancer.
- WARNING: Cigarettes cause strokes and heart disease.
- WARNING: Smoking during pregnancy can harm your baby.
- WARNING: Smoking can kill you.
- WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. (1)
The full force and effect of the expansion to Title 21 has not yet been realized. Future activities include, but are not limited to:
- Jan 2011 – A group of experts will be created by the FDA to create a document for Congress, due July 2013, that will examine how best to regulate, promote, and encourage the development of innovative products and treatments to help public health based on abstinence and reducing consumption of tobacco (1)
- Jan 2011 – Stricter regulations will be released regarding the sale and distribution of tobacco products that occur through means other than a direct, face-to-face exchange in order to prevent purchase by minors (1)
- July 2011 – A tobacco product manufacturer will no longer be able to use tobacco that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco. (1)
- July 2012 – 2014 –Testing and reporting of tobacco product constituents, ingredients, and additives that the Secretary determines should be tested to protect the public health.
- July 2012 – 2014 –The Secretary will enforce regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice, or hazard analysis and critical control point methodology.
- Based on the above regulation, tobacco companies will need to establish Quality Systems in order to ensure compliance. (21 CFR 820 Quality System Regulation (GMP—Good Manufacturing Process). The following components of Quality Systems will need to developed:
- Quality By Design and Product/Process Development
- Risk Management
- Quality System Training
- CAPA Programs
- Material Control, Component Control, and Lot Release
- Change Control
- Management Training
- Quality Audits
- New product registration (1)
Within the past year there has been significant progress on the goals of the new regulations. Margaret Hamburg, Commissioner of the FDA, acknowledges the progress, but notes that there is much more work ahead, “As we complete our first year executing this important new responsibility, FDA has much to be proud of and much yet to do to improve public health through effective tobacco regulation.” (13)
Much of the progress reported within this blog reflects activity on the Federal Level, and has been made public by the FDA. As industrial progress becomes more visible, we will endeavor to track and report it in subsequent postings.
It is critical to note that the challenges posed to industry by these regulations are significant; constructing a corporate infrastructure designed to interact with FDA and meet the definitions of modern Quality Systems cannot be achieved overnight. The act of constructing these systems, while maintaining corporate supply chains, represents complex change and extraordinary evolution of corporate culture.
All of us at Coda Corp USA and our blog followers may never before have had the opportunity to witness such large scale change enfold. We all understand the magnitude of change required by the expansion of Title 21, fully support this new collaboration, and wish all involved patience and success during this time of change.
© Coda Corp USA 2010. All rights reserved.
__________________________
Authors:
Corrine R. Knight & Gina Guido-Redden
Coda Corp USA
References
1) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ031.111.pdf
2) http://www.drugabuse.gov/infofacts/tobacco.html
3) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180109.htm
4) http://tobaccoreporter.com/home.php?id=498&art=3483
5) http://www.businessweek.com/magazine/content/10_27/b4185014579409.htm?campaign_id=rss_null
6) http://www.tobaccojournal.com/index.php?id=50051
7) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm183211.htm
8) http://tobaccoreporter.com/home.php?id=498&art=3541
9) http://tobaccoreporter.com/home.php?id=498&art=3466
10) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179410.htm
11) http://www.capitolconnection.net/capcon/fda/fda071510_launch.htm#
12) http://www.fda.gov/ForIndustry/UserFees/TobaccoProductFees/default.htm
13) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216406.htm
14) http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214474.htm
15) http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214425.htm
16) http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214598.htm
17) (Title 21, Chapter IX, Section 915 (b1)
18) (Title 21, Chapter IX, Section 906 (e1)
