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FDA Issues Guidance for Submission of Warning Plans for Cigars

The U.S. Food and Drug Administration (FDA) recently issued guidance for industry to assist with the submission of warning plans for cigars. On May 10, 2016, FDA published a final rule that granted the agency authority to regulate all tobacco products, including cigars, e-cigarettes, hookah tobacco, and pipe tobacco.

What is a warning plan?

A warning plan details how a company plans to achieve random distribution of the required warning statements on cigar packages and advertisements. For each brand of a cigar product, FDA requires that all statements be displayed on packaging an equal number of times within a 12-month period.  All statements must be randomly distributed in all areas that the product is marketed in the US. For advertising, all warning statements must rotate quarterly in an alternating sequence. There are six required warning statements:

  1. WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  2. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  3. WARNING: Cigar smoking can cause lung cancer and heart disease.
  4. WARNING: Cigars are not a safe alternative to cigarettes.
  5. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  6. There are two options for the reproductive health warning: 1) WARNING: Cigar use while pregnant can harm you and your baby, or 2) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight

Who submits the cigar warning plans?

A cigar product manufacturer, distributor, importer, or retailer should submit the warning plan. In most circumstances, FDA believes that manufacturers are most capable of creating a sufficient warning plan for packaging.

What is the compliance deadline?

Warning plans for cigars should be submitted to FDA by May 10, 2017 or 12 months before advertising and marketing begin, whichever date is later. FDA expects that a large volume of plans will be submitted near this deadline and thus suggests they be submitted as soon as possible to ensure they are reviewed in time to comply with the warning requirements that take effect on May 10, 2018.   FDA has deemed it unlawful for cigar products to be produced, manufactured, or distributed in the United States without the packaging containing one of the required statements once the warning requirements take effect.

FDA encourages cigar product manufacturers, distributors, importers, and retailers to submit warning plans electronically, with all content in Portable Document Format (PDF) format.  Electronic submissions must be submitted through FDA’s Electronic Submissions Gateway.

Registrar Corp is a U.S. FDA consulting firm that helps companies comply with FDA regulations.  Registrar Corp can help tobacco product manufacturers determine how FDA’s guidance apply to their particular products.  Additionally, Registrar Corp can also review tobacco product labels and advertisements to ensure compliance with FDA labeling regulations. For more information, contact Registrar Corp at
+1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp

FDA Extends Compliance Date for Tobacco Ingredient Submissions

The U.S. Food and Drug Administration (FDA) recently issued a guidance that extends the compliance dates for tobacco ingredient submissions for newly deemed tobacco products introduced into interstate commerce on or before August 8, 2016. FDA plans to enforce the ingredient list submission requirement on August 8, 2017 for businesses that are not small-scale manufacturers, and on February 8, 2018 for small-scale manufacturers. The original date for compliance was February 8, 2017.

The compliance deadlines have been extended to allow manufacturers and importers additional time to prepare quality submissions. The extension also allows some manufacturers to submit multiple lists for multiple tobacco products.

Ingredient submissions should include the following information:

  • Manufacturer/Importer Identification
  • Product Identification
  • Ingredient Identification
  • Ingredient Quality

Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements. For more information on FDA regulations for tobacco manufacturers, including the recently finalized refuse to accept tobacco rule, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

 

 

FDA Finalizes Refuse to Accept Rule for Tobacco Submissions

On December 29, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 95863) describing the circumstances under which the agency will refuse to accept a tobacco product submission.  Covered submissions include:

  • Premarket tobacco product applications (PMTAs)
  • Modified risk tobacco product applications (MRTPAs)
  • Substantial equivalence (SE) applications
  • Exemption requests

According to the rule, FDA will refuse to accept submissions that:

  • Are not in English
  • Do not pertain to a tobacco product
  • Do not identify the tobacco product or the type of submission
  • Are submitted in an electronic format that cannot be processed, read, reviewed, or archived
  • Do not include the applicant’s contact information (or for foreign applicants, the U.S. Agent’s contact information)
  • Do not include the required forms
  • Do not include the signature of a responsible official authorized to represent the applicant
  • Do not include an environmental assessment or claim of a categorical exclusion, if applicable

Submissions that meet these circumstances will be refused before they enter FDA’s review queue.  FDA will inform the listed contact as to whether or not the submission was accepted.  FDA expects this rule to accelerate the review process for submissions that meet all requirements by freeing the agency’s review resources.

This rule applies to covered submissions for all tobacco products.  Until last year, FDA’s authority over tobacco products was limited to cigarettes and cigarette, roll-your-own, and smokeless tobacco.  In May 2016, FDA finalized a rule that extended the agency’s authority to all tobacco products, including (but not limited to) e-cigarettes, cigars, hookah tobacco, and pipe tobacco (81 FR 28973).  The rule became effective in August 2016 and requires tobacco manufacturers to submit new products to FDA for premarket review.

Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements.  For more information on FDA regulations for tobacco manufacturers, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Manufacturers of E-Cigarettes and Other Tobacco Products Must Register with FDA, List their Products, and More

On May 10, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 28973) that extends the agency’s authority to all tobacco products, including (but not limited to) e-cigarettes, cigars, hookah tobacco, and pipe tobacco.  The final rule becomes effective on August 8, 2016 (90 days from the date of publication).

FDA considers tobacco use to be a significant threat to public health.  According to FDA, smoking is the leading cause of preventable disease and death in the United States. Under the final rule, newly-regulated tobacco products are subject to premarket review and authorization by FDA.  Manufacturers of these newly-regulated tobacco products must register their establishments and list their products with FDA as well as place health warnings on product packages and advertisements.  Manufacturers will not be able to market their tobacco products as modified risk (i.e., “light”, “low”, or “mild”) without FDA authorization.  Manufacturers must also report ingredients and harmful and potentially harmful constituents to FDA.

Registration and Listing Requirements: Differences for Domestic and Foreign Manufacturers

The new registration and listing requirements will initially only apply to domestic tobacco manufacturers. Section 905 of the Food, Drug, and Cosmetic Act requires FDA to issue a rule through the notice and comment rulemaking process in order to apply the registration and product listing requirements to foreign manufacturers.  FDA has announced its intent to issue a rule requiring registration and listing for foreign tobacco manufacturers in theUnified Agenda and expects to publish the proposed rule in September 2016.

Registrar Corp can assist tobacco manufacturers in registering and listing their products with FDA per the new requirements.

The Rule’s Effect on Youth Access to Tobacco Products

While the use of traditional cigarettes by minors has decreased, their use of other tobacco products has increased significantly.  According to FDA, e-cigarette use among high school students rose from 1.5 percent in 2011 to 16 percent in 2015 (a 900 percent increase). A goal of FDA’s final rule is to protect youth from the dangers of tobacco via age-restrictions and restricting advertising that appeals to minors.

Before FDA finalized the rule, there were no federal regulations prohibiting the sale of e-cigarettes, hookah tobacco, or cigars to consumers under the age of 18.  Under the new rule, these products can no longer be sold to minors, either in person or online.  Sellers must verify the age of purchasers by photo identification.  The rule also prohibits the distribution of free samples or selling covered tobacco products in vending machines (unless in an adult-only facility).

Registrar Corp is a U.S. FDA consulting firm that helps companies comply with FDA regulations.  Registrar Corp can help tobacco product manufacturers determine how FDA’s new rule applies to their particular products.  Registrar Corp can register manufacturers and list tobacco products with FDA as well as review tobacco product labels and advertisements to ensure compliance with FDA labeling regulations.

For more information, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.





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