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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 the Unified 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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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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