DOCSLIB.ORG

Nonprescription Drugs Advisory Committee Meeting September 18

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Nonprescription Drugs Advisory Committee Meeting September 18 FDA Briefing Document NDA 208-425 Nicotine Mouth Spray Nonprescription Drugs Advisory Committee Meeting September 18, 2019 The committee will discuss data submitted by GlaxoSmithKline to support new drug application (NDA) 208-425, for over-the-counter (OTC) marketing of nicotine mouth spray, 1 mg. The proposed OTC use is to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. The applicant proposes to label the product for 18 years and older. The committee will be asked to consider whether data support an acceptable benefit-risk profile for the nonprescription use of nicotine mouth spray, 1 mg by OTC consumers. i FDA Briefing Document NDA 208-425 Nicotine Mouth Spray Disclaimer Statement The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. We have brought NDA 208-425 to this Advisory Committee in order to gain the Committee’s insights and opinions, and the background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the advisory committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting. ii FDA Briefing Document NDA 208-425 Nicotine Mouth Spray Table of Contents Table of Tables ....................................................................................................................v Table of Figures ................................................................................................................ vii Division Director Memorandum ..........................................................................................8 Draft Topics for Discussion ...............................................................................................12 1. Introduction ....................................................................................................................13 2. Background ....................................................................................................................13 3. Summary of Presubmission/Submission Regulatory Activity .......................................16 4. Drug Product Summary .................................................................................................17 5. Labeling Summary .........................................................................................................17 6. Clinical Pharmacology Summary ..................................................................................18 6.1. Results from Study NICTDP1065 ...........................................................................20 6.2. Results from Study NICTDP1066 ...........................................................................22 7. Summary of Clinical Trials ............................................................................................25 7.1. Review of Efficacy ..................................................................................................25 7.1.1. Study A6431111: Efficacy and Safety following use of a Novel NRT. Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 52-Week Study in Smokers Motivated to Quit (Study 11)..................26 7.1.2. Study CO-140121222102-SCCT (formerly NICTDP3038): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Using a Naturalistic Clinical Model to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers Motivated to Quit (Study 38) ............................................................34 7.1.3. Efficacy Conclusion ..........................................................................................47 7.2. Review of Safety .....................................................................................................49 7.2.1. Sources of Data .................................................................................................49 7.2.2. Review of Safety Database ...............................................................................52 7.2.3. Safety Results ...................................................................................................53 7.2.4. Safety Conclusions ...........................................................................................63 8. Summary of Postmarketing Safety ................................................................................64 8.1. Applicant Global Safety Database ..........................................................................65 8.2. FDA FAERS Search ................................................................................................70 8.2.1. FAERS Search Strategy ....................................................................................72 8.2.2. FAERS Cases....................................................................................................73 8.2.3. Additional FAERS ORAL NRT Adverse Event Search ..................................76 8.3. FDA World Health Organization VigiBase Search ................................................78 8.3.1. World Health Organization VigiBase Database Search Strategy .....................79 8.3.2. World Health Organization VigiBase Cases ....................................................79 8.4. Literature Search .....................................................................................................81 iii FDA Briefing Document NDA 208-425 Nicotine Mouth Spray 8.5. Conclusions .............................................................................................................84 9. Label Comprehension Study #181093 ...........................................................................84 9.1. Background and Executive Summary .....................................................................84 9.1.1. General Background on Label Comprehension Studies ...................................84 9.1.2. Executive Summary ..........................................................................................86 9.1.3. Regulatory History of LCS #18109 ..................................................................87 9.2. Study Design and Conduct ......................................................................................87 9.3. Study Results ...........................................................................................................90 9.3.1. Visibility of Directions for Use ........................................................................90 9.3.2. Primary Endpoint Analysis ...............................................................................92 9.3.3. Secondary Endpoint Analysis ...........................................................................95 9.3.4. Additional Analyses ..........................................................................................99 9.3.5. Conclusions.....................................................................................................100 10. Human Factors Validation Study ...............................................................................101 11. Appendix ....................................................................................................................103 11.1. Summary of Presubmission Activities ................................................................103 11.2. Drug Facts Label and Directions for Use ............................................................108 12. Glossary .....................................................................................................................114 13. References ..................................................................................................................115 iv FDA Briefing Document NDA 208-425 Nicotine Mouth Spray Table of Tables Table 1. Approved Smoking Cessation Aids .....................................................................14 Table 2. Timeline of Key Regulatory Activities ................................................................16 Table 3. Nicotine Mouth Spray Treatments, Study NICTDP1065 ....................................20 Table 4. Nicotine Pharmacokinetic Parameters (Mean ± SD) After NMS, Nicorette Gum 4 mg and NiQuitin Lozenge 4 mg Single-Dose Treatments (Study NICTDP1065) ..............................................................................................................21 Table 5. Nicotine Baseline Corrected Cmax and AUC∞ (cCmax and cAUC∞) From the NMS Single-Dose (Study NICTDP1065) ....................................................................22 Table 6. Nicotine Mouth Spray Treatments, Study NICTDP1066 ....................................22 Table 7. Steady-State Pharmacokinetic Parameters After NMS, Nicorette Gum 4 mg and NiQuitin Lozenge 4 mg Treatments (Study NICTDP1066) .................................24 Table 8. Pharmacokinetic Parameters (Mean ± SD) and Ratios* Between Pharmacokinetic Parameters Between Self- vs. Staff-Administered NMS 2 mg/h (Geometric
Load more

Recommended publications
  • Nicotine Replacement Therapy Using Medications to Help You Quit Smoking Can Double Your Chances of Quitting
    Boston Medical Center Tobacco Treatment Team Tips to Get the Most Benefit From Your Nicotine Replacement Therapy Using medications to help you quit smoking can double your chances of quitting. To gain the most benefit, nicotine patches are often used in combination with nicotine gum or lozenges. Continue to use the patch and gum/lozenge for at least 6 weeks or as prescribed. You may keep a few pieces of gum or lozenge to use in order to prevent a relapse after the six weeks. If you have any questions concerning your nicotine replacement medications, contact your health care provider, pharmacist or call the Tobacco Treatment line at 617 638 7665. NICOTINE PATCHES How to use Every morning, place a fresh patch on a hairless area of skin between your neck and waist Keep the patch on for a full 24 hours before removing. When you remove the old patch, place a new patch on a different area of skin. o Using the same area of skin can cause skin irritation or rash, so it is best to rotate sites. The patch sticks best when skin is clean and dry. o Avoid lotion/oils on skin where you will place patch, as this may prevent the patch from sticking. o Do not use on skin that has a rash or cut. Helpful hints Some people notice trouble sleeping or nightmares after starting the patch. o If you have these, try taking the patch off each night at bedtime. o Place a new patch in the morning. It is best to avoid smoking while using the patch.
    [Show full text]
  • Using the Nicotine Gum Using the Nicotine Gum Using the Nicotine Gum Using the Nicotine Gum
    Using the Nicotine Gum Using the Nicotine Gum Using the Nicotine Gum Using the Nicotine Gum Nicorette® is a sugar-free nicotine gum used to help smokers slowly get off Nicorette® is a sugar-free nicotine gum used to help smokers slowly get off Nicorette® is a sugar-free nicotine gum used to help smokers slowly get off Nicorette® is a sugar-free nicotine gum used to help smokers slowly get off nicotine.When chewed correctly, and used on a regular schedule, it supplies a nicotine.When chewed correctly, and used on a regular schedule, it supplies a nicotine.When chewed correctly, and used on a regular schedule, it supplies a nicotine.When chewed correctly, and used on a regular schedule, it supplies a steady stream of nicotine to the body through the lining of the mouth.This steady stream of nicotine to the body through the lining of the mouth.This steady stream of nicotine to the body through the lining of the mouth.This steady stream of nicotine to the body through the lining of the mouth.This may help reduce the withdrawal symptoms that occur during the first weeks may help reduce the withdrawal symptoms that occur during the first weeks may help reduce the withdrawal symptoms that occur during the first weeks may help reduce the withdrawal symptoms that occur during the first weeks of quitting smoking. of quitting smoking. of quitting smoking. of quitting smoking. Obtaining the Gum: its taste.The nicotine gets into your bloodstream Obtaining the Gum: its taste.The nicotine gets into your bloodstream Obtaining the Gum: its taste.The nicotine
    [Show full text]
  • Nicotine Gum
    Nicotine gum Please note: This information is not intended to replace the Consumer Medicine Information (pack insert) that may come with the nicotine gum. If you do not have a pack insert, ask your pharmacist for it, or for advice if one is not available. Main points about nicotine replacement therapy products • All forms of nicotine replacement therapy (NRT) products – patches, lozenges, mouth spray, gum and inhalator – have been proven to help people quit smoking.1 • Using NRT products is always safer than continuing to smoke.2 NRT products are a safe alternative to cigarettes for smokers.3 • Using NRT products will still increase your chances of quitting even if it does not completely control cravings.4 • NRT products reduce the severity of cravings but you may still have them, especially in situations in which you are used to smoking. 5-7 • Using the patch plus another NRT product (combination therapy) increases your chance of stopping smoking compared to just using one NRT product, and is better at suppressing cravings.8, 9 • NRT products work better when you also reduce triggers for cravings. Boost your chance of success by making your home smokefree and if possible, get rid of all cigarettes in your home and car.10, 11 You will also need to find new habits to take the place of smoking; for example, when you’re stressed, socialising, concentrating, filling in time or when drinking alcohol or coffee. • Research shows that people who have the best chance of stopping smoking using NRT products also get advice or support from their doctor, pharmacist or other trained advisor (such as through the Quitline).1, 12, 13 • If you slip-up and have a cigarette, it is safe to continue using NRT products and to keep trying to quit.14 • It is common for smokers to attempt to quit a number of times before they successfully stop.15 09/19 2 Is nicotine gum suitable for me? Nicotine gum works best for addicted smokers who want to quit.1 Your doctor or pharmacist can advise you whether nicotine gum is suitable for you.
    [Show full text]
  • Tips from Experts to Make Nicotine Replacement Work Better
    TIPS FROM EXPERTS TO MAKE NICOTINE REPLACEMENT WORK BETTER If you are fed up with smoking and have tried nicotine gum, lozenge or patch on your own without success read these tips. These tips were made by a panel of Tobacco Treatment Specialists. They wanted to find out important information about how to be successful with Nicotine Replacement Therapy (NRT) products that the package insert may not tell you. Your doctor wants you to have this information to help you quit. Your doctor wants to support you in quitting in any way possible. Some examples: www.californiasmokershelpline.org FREE: 1-800-NO-BUTTS Tip #1: NRT is ONE good tool to help you quit Telephone smoking. But NRT can’t do all the work for Counseling, American Lung Association you—you have to help—and it is not the only Therapy counseling 1-800-LUNG-USA or tool to help you stop smoking. Ask your doctor 510-893-5474 x375 12 Step program, about other medications and counseling resources Group Counseling www.nicotine-anonymous.org that can help you give up tobacco for good. Buddy system FREE: 510-521-5025 Hypnosis, Acupuncture Tip #2: Don’t worry about the safety of using NRT to stop smoking: NRT is a safe alternative to cigarettes for NRT smokers. Important info that package inserts don’t Tip #7: If NRT helps Tip #3: Do be tell you. cautious about using you stop smoking, but NRT while you go back to smoking pregnant. Check when you stop using with your doctor. NRT, you should seriously think about using NRT again the Tip #4: NRT is less next time you try to addictive than stop smoking.
    [Show full text]
  • Mayo Clinic NDC Tobacco Dependence Treatment Medication Summary*
    Mayo Clinic NDC Tobacco Dependence Treatment Medication Summary* Nicotine Replacement Therapy (NRT) Description & Examples Pros & Cons Comments Dosing Recommendations Nicotine patch Pros Comments and limitations Dosing (24-hour patch) Achieve desired levels of replacement Patches vary in strengths and the length of time (OTC) over which nicotine is delivered. Depending on >40 cpd = 42 mg per day Easy to use Only needs to be applied once a day the brand of patch used, may be left on for 21-39 cpd = 28-35 mg per day 24-hour delivery systems: anywhere from 16 to 24 hours. Patches may be 10-20 cpd = 14-21 mg per day 21, 14, 7 mg/24 hour Few side effects placed anywhere on the upper body, including <10 cpd = 14 mg per day Cons Less flexible dosing arms and back. Rotate the patch site each time a 16-hour delivery systems: new patch is applied. If a dose > 42mg per day may be indicated, 15, 10, 5 mg/16 hour Slower onset of delivery contact the patient’s prescriber. Adjust based on Mild skin rashes and irritation May purchase without a prescription. withdrawal symptoms, urges, and comfort. (Generic available) After 4-6 weeks of smoking abstinence, taper every 2-4 weeks in 7-14 mg steps as tolerated. Nicotine lozenge Pros Comments or limitations Dosing as monotherapy Easy to use Use at least 8-9 lozenges per day initially. Based on time to first cigarette of the day: Regular or “mini” size Delivers doses of nicotine approximately 25% Efficacy and frequency of side effects related to <30 minutes = 4 mg (OTC) higher than nicotine gum amount used.
    [Show full text]
  • 2 Or 4 MG NICOTINE GUM Recipient Instruction Education Form
    2 or 4 MG NICOTINE GUM Recipient Instruction Education Form 1. Chew each nicotine gum piece very slowly several times. Stop chewing when you notice a peppery taste andlor a slight tingling in your mouth. (This usually happens after about 15 chews, but may vary from person to person.) 2. "Park" the nicotine gum piece between your upper lip and gum and leave it there. 3. When the peppery taste or tingle is almost gone (in about a minute), start to chew a few times slowly again until the taste or tingle returns. Stop chewing the nicotine gum piece. 4. Park the nicotine gum piece again on the other side of your mouth between your upper lip and gum. 5. Repeat steps 1-4 (chew, park, chew, park) until most of the taste/tingle is gone from the nicotine gum piece (usually happens in about half an hour to one hour.) 6. Wrap gum in a piece of tissue and throwaway out of reach of children and pets. * Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 I piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours Do not use more than 24 pieces per day. Stop using nicotine gum at the end of Week 12. If you feel that you still need to use nicotine gum, talk with your health care provider. ____ Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products without consulting your health care provider.
    [Show full text]
  • The Details of Nicotine Replacement Medications
    Tobacco/Smoking Cessation Medications The Details of Nicotine Replacement Medications The U.S. Food and Drug Administration (FDA) has approved the following medicines to help you quit smoking. The following medicines are Nicotine Replacement Therapy (NRTs). These medicines provide nicotine to your body in a different way than tobacco. You also get less nicotine with NRTs than from tobacco. Using an NRT when you quit can lessen cravings and withdrawal symptoms. Follow these recommendations to receive the most benefit: • Start taking an NRT before or on your Quit Day. ◦ Read and follow the package instructions to make sure you: ◾ use the correct technique ◾ use the correct dose for the amount you smoke NRTs include nicotine patch, gum, lozenge, nasal spray and inhaler. Nicotine Patch The nicotine patch (Habitrol, NicoDerm, CQ, Nicotrol) is a nicotine replacement medicine. The nicotine patch slowly releases nicotine to your body through your skin. This keeps the nicotine in your body steady throughout the day to ease withdrawal symptoms. This allows you to focus on breaking your smoking routines and learn new coping skills. Nicotine patches are available over-the- counter. There are three different strengths of the nicotine patch: 21mg, 14mg or 7mg. The dose and duration recommendations vary by individual. Follow the directions on the label, and ask your doctor or pharmacist to explain any part you do not understand. Use the nicotine patch exactly as directed. How to Apply the Patch • Choose a non-hairy, clean, dry area of skin; do not apply lotion or sunscreen on this area. • Avoid placing the patch over joints (ankles, knees, elbows) or skin that is burned, broken out, cut or irritated in any way.
    [Show full text]
  • Recommendations for Use of Combination Therapy in Tobacco
    PBM-MAP Recommendations for Use of Combination Therapy in Tobacco Use Cessation Recommendations for Use of Combination Therapy in Tobacco Use Cessation April 2009 VHA Pharmacy Benefits Management Services, Medical Advisory Panel, Tobacco Use Cessation Technical Advisory Group, and Public Health Strategic Healthcare Group The following recommendations are based on medical evidence, clinician input, and expert opinion. The content of the document is dynamic and will be revised as new information becomes available. The purpose of this document is to assist practitioners in clinical decision-making, to standardize and improve the quality of patient care, and to promote cost-effective drug prescribing. The clinician should utilize this guidance and interpret it in the clinical context of the individual patient. Individual cases that are outside the recommendations should be adjudicated at the local facility according to the policy and procedures of its P&T Committee and Pharmacy Services. Tobacco dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit. Effective treatments exist that can significantly increase rates of long-term abstinence and are supported by the 2008 United States Public Health Services Update of Clinical Practice Guidelines on the Clinical Treatment of Tobacco Use and Dependence (USPHS CPG). One such recommendation included in these guidelines is the use of combinations of first-line medications in patients who are willing to quit smoking. Combination Nicotine Replacement Therapy (NRT) involves the use of a long acting nicotine formulation (patch) in combination with a short acting formulation (gum, lozenge, inhaler, or nasal spray). Combination NRT offers constant levels of nicotine replacement provided by the patch and prevents the onset of severe withdrawal symptoms while the short acting nicotine replacement delivers nicotine at a faster rate and is used as needed to control breakthrough cravings and withdrawal symptoms that may occur during potential relapse situations (i.e.
    [Show full text]
  • Management of Nicotine Addiction
    Management of Nicotine Addiction Authored by: Charlene Roberson, MEd, RN-BC, Disclosures: Neither the author or planning committee have any conflict of interest. Target audience: All health care workers Purpose/Goal: To enable nurses to provide supportive care to patients attempting to withdraw from nicotine Learning Outcome: The Nurse will be able to explore the addictive properties of nicotine and provide guidance for the various methods of nicotine reduction and/or cessation. Contact Hours: 1.5 (ANCC) and 1.8 (ABN). Contact Hours are valid February 28, 2018 through June 18, 2022. Fees: ASNA Member $ free Non Member $15 (Fees must be paid on line and the same time as the completing the evaluation and may be accessed by clicking here.) Accreditation: The Alabama State Nurses approved as a provider of nursing continuing professional development by The Mississippi Nurses Foundation, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. Alabama Board of Nursing Provider Number ABNP0002 (expires April 6, 2021). Instructions for Credit: Participants should read the purpose and learning objectives on line or printed out. After reading complete the post test at the end of the activity and compare your responses to the answers provided and review any incorrect response(s). Participants must complete the evaluation on line and submit the appropriate fee to receive continuing nursing education credit. The Certificate of Attendance will be generated after the evaluation has been completed. ASNA will report the contact hours to the Alabama Board of Nursing within 2 weeks of completion. Management of Nicotine Addiction Nicotine addiction is public health dilemma in both the United States and worldwide.
    [Show full text]
  • Smoking Cessation
    VMJ0010.1177/1358863X16661767Vascular MedicineRatchford and Evans 661767research-article2016 Vascular Disease Patient Information Page Vascular Medicine 2016, Vol. 21(5) 477 –479 Smoking cessation © The Author(s) 2016 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1358863X16661767 vmj.sagepub.com Elizabeth V Ratchford1 and Natalie S Evans2 Keywords bupropion, cigarettes, nicotine replacement, smoking cessation, tobacco, varenicline I know smoking causes lung reduce the chances of stents or bypasses closing up. It will cancer, but are there other risks of also decrease the risk of amputation. smoking? On average, smokers die 10 years earlier than non-smokers, What are the risks with cigars? and smoking causes almost one in every five deaths in the How about snuff or chew? 1 United States. Smoking is linked to many cancers, heart The idea that cigars are safer is simply a myth. Less research disease, vascular disease, macular degeneration, osteoporo- is available on the dangers of cigars and smokeless tobacco sis, diabetes, stroke, and chronic obstructive pulmonary (such as snuff, chew, or snus), as compared to cigarette disease (COPD). Quitting smoking is hard, but it is far and smoking. However, cigars and smokeless tobacco are clearly away the most important action you can take to improve linked to cardiovascular disease and cancers of the mouth, your overall health. esophagus, and pancreas. Cigar smoke may even be more toxic than cigarette smoke. Smokeless tobacco is thought to What does smoking have to do be somewhat less risky than cigarettes, but tobacco is not with vascular disease? safe in any form. Smoking and vascular disease go hand in hand.
    [Show full text]
  • Nicotine Replacement Therapy (NRT) Works by Substituting the Source of Nicotine to “Replace” the Nicotine You Inhale When You Smoke
    NICOTINE REPLACEMENT THERAPY Nicotine replacement therapy (NRT) works by substituting the source of nicotine to “replace” the nicotine you inhale when you smoke. For people who are quitting smoking, NRTs can help by delivering a safer alternative source of nicotine than cigarettes. They also can reduce or eliminate the symptoms of withdrawal, making it easier for some people to quit. NRTs have been extensively tested and used by millions of people. They are considered safe and effective ways of quitting smoking. Possible effects of too much nicotine: Feeling sick, faint, light headed/ headache, palpitations Possible side effects from stopping smoking Irritability Urges to smoke Low mood Lower heart rate Anxiety Increased appetite Restless Weight gain Poor concentration Sleep disturbance Precautions when using nicotine replacement Cardiovascular disease: Using nicotine replacement is less hazardous than smoking. If you have had a heart attack, severe dysrhythmia or a stroke within the last four weeks you should ideally try to stop smoking independently. If you are unable to stop smoking, using nicotine replacement is less hazardous than smoking and should be used under supervision. Diabetes mellitus As nicotine can affect your carbohydrate metabolism you may require less insulin as a result of stopping smoking or reducing the amount of nicotine replacement. It is therefore recommended that you monitor your blood sugar levels closely. Phaochromocytoma/ uncontrolled hyperthyroidism: Use nicotine replacement with caution with these conditions. This is because when you stop smoking your metabolism is slower and consequently there may be a rise in the blood levels of the following drugs: theophylline, clozapine and ropinirole Peptic ulcer/inflamed stomach lining: Some oral nicotine replacement products can cause irritation to the stomach.
    [Show full text]
  • FDA Regulation of Tobacco Products
    FDA Regulation of Tobacco Products Updated July 9, 2021 Congressional Research Service https://crsreports.congress.gov R45867 SUMMARY R45867 FDA Regulation of Tobacco Products July 9, 2021 Cigarette use remains the leading cause of preventable death in the United States, claiming an estimated 480,000 lives or more each year. Although cigarette use in the United States continues Hassan Z. Sheikh to decline, according to the Centers for Disease Control and Prevention (CDC), an estimated 34.1 Analyst in Public Health million American adults smoked cigarettes every day or some days in 2019, and nearly 910,000 Emergency Management American middle and high school students had smoked cigarettes within a 30-day period in 2020. In recent years, electronic nicotine delivery systems (ENDS) have become increasingly popular. Victoria R. Green ENDS is an umbrella term for various types of electronic tobacco products, including electronic Analyst in Health Policy cigarettes (e-cigarettes). An e-cigarette is a battery-operated device typically containing nicotine, flavorings, and other chemicals that, when heated, creates inhalable vapor. According to CDC analyses, 10.9 million American adults used e-cigarettes every day or some days in 2019, and about 3.58 million American middle and high school students had used an e-cigarette within a 30-day period in 2020. FDA Regulation of Tobacco Products The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), is responsible for regulating the manufacture, marketing, distribution, and sale of tobacco products. FDA’s Center for Tobacco Products (CTP)—established in 2009 pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA; P.L.
    [Show full text]