FDA Offers Guidance on Submitting Comments

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FDA Offers Guidance on Submitting Comments


WASHINGTON, D.C. -- Retailers and suppliers planning to submit comments to the U.S. Food and Drug Administration (FDA) regarding the agency's proposed tobacco deeming regulations or any other topic must make it very clear if they are for or against the proposal, and provide reasons why.

"Make sure to be clear about why you oppose or support something," Dr. Allison Hoffman, associate director of the FDA's Office of Science, Center for Tobacco Products (CTP), said during a FDA-sponsored webinar entitled, "What Makes a Good Comment," held Friday. "And providing support to back up the claims is big. To do so, you can upload files and attach them to the document."

As CSNews Online previously reported, the FDA issued proposed deeming regulations on April 24. The organization wants to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and certain dissolvables not already under its authority.  

The agency already has the authority to regulate tobacco products under the Family Smoking and Tobacco Control Act of 2009, but the FDA must issue deeming regulations to extend its authority to cover additional tobacco products.

The proposed deeming regulations call for minimum age and identification restrictions to prevent the sale of such products to underage youth; requirements to include health warnings; and prohibition of vending machine sales unless in a facility that never allows minors, such as bars and nightclubs.

The public comment period for deeming regulations is underway now. It is set to expire 75 days after the April 24 date, which falls on July 9. During Friday's webinar, Dr. Hoffman said she could not comment as to whether an extension will be granted. That question needs to be posed to FDA lawyers, she stated. 

The CTP's associate director, however, did provide plenty of additional detail regarding the comment submission process. She stressed that any comment submitted to the agency during an open submission period must be read by the CTP, without exception. She also explained that the CTP prefers electronic submissions vs. paper submissions, because a receipt to prove the comment was submitted is created immediately with an electronic submission. 

Anything submitted becomes a public comment that anyone can read. "Anyone submitting something that is proprietary should contact us first [at (877) 287-1373]," said Dr. Hoffman. "There is a chance parts of the comment can be redacted."

During a question-and-answer session, Dr. Hoffman concluded by debunking a theory that larger companies have more influence on the FDA's final decisions than individual retailers or smaller companies. "That is not the case," she said. "The comment itself and the support to back up that comment is the most influential."

To submit a comment electronically, visit www.regulations.gov and follow the instructions.