Small business groups, pizza chains, and grocery associations are worried that the Trump administration is moving ahead with an ambiguous Obamacare rule that mandated calorie counts on menus.
The Food and Drug Administration delayed the compliance date of the regulation earlier this year until May 2018, giving groups hope that controversial parts of the rule, such as a 171-word definition of a menu that includes food advertisements and criminal penalties for "misbranding" food with the wrong calorie counts, would be clarified.
However, FDA commissioner Scott Gottlieb said last month that the administration would not reopen the rule for changes. Instead, the FDA will issue nonbinding guidance to companies to address "legitimate concerns about the regulation as it was drafted."
"It's going through clearance right now, we are going to issue the guidance at some point … in the fall and that will keep us on schedule to implement that on time in May," Gottlieb said.
Previous guidance did not address core concerns with the rule and made matters worse. The final guidance under the Obama administration expanded the definition of menu to 171 words. It included anything "from which a customer makes an order selection," which would apply to advertisements and coupons.
Groups such as the American Pizza Community, a coalition of pizza chains representing Domino's, Papa John's, and others, and the Food Marketing Institute, which represents food retailers, have voiced concerns that the FDA has not adequately addressed thousands of comments submitted to the government on how to fix the rule.
When the Trump administration delayed the compliance date, it opened up the regulation to public comment for 60 days. Then-HHS Secretary Tom Price called the Obama regulation as it stood "unwise and unhelpful." The FDA said retailers have "raised concerns about how the rule lacks flexibility," and the agency received questions on "how to distinguish a menu" from advertisements.
Shortly after the comment period ended, Gottlieb said the agency was already drafting guidance for the rule.
"The administration got off to a great start," said Robert Rosado, director of food and health policy at the Food Marketing Institute. "Now we're getting concerned because we submitted [30 pages worth of comments] at the beginning of August, and then just a few weeks later, there have been some comments coming out of FDA that seem to give us the impression that they've veered off this path and instead of reviewing the rule and making some changes to the rule, they're talking about things like guidance."
"While that may sound good in Washington speak, the problem is that we've been through guidance before with the previous FDA team, and the guidance has just been cut and paste of the same," Rosado said. "Frankly, we're concerned that this issue and this process has been hijacked a little bit."
Domino's franchisee Chris Reisch, who worked his way up from a delivery driver when he was stationed in the Army at Ft. Myer to own 10 stores and employ 250 people, said he has real concerns about the regulation including criminal penalties for mislabeling the calorie counts on a pepperoni pizza.
"You may say, 'Well, that's really never going to happen that someone's going to get a felony for overtopping pepperoni on a pizza,'" he said. "Until it happens. If you say, that's never going to happen, then why is it written into the law?"
As written, violations of the regulation can carry civil and criminal penalties of up to a $1,000 fine, one year in prison, or both.
"Giving guidance really isn't going to be helpful for us in our situation. And as a small business owner, it's scary," Reisch said. "I want things cut and dry, I want the law changed so it's easily managed. And we don't want it removed. We already provide calorie counts online. We have a 21st century solution to the problem. The majority of our customers now place their orders electronically. They're placing their orders in the means we have it available."
An FDA spokesperson pointed the Washington Free Beacon to Gottlieb's statement in August about releasing guidance with "uniform federal standards." "The FDA takes seriously our responsibility to ensure that food is labeled in a manner that provides people with the information they need to make healthy choices," he said.
"We will provide additional, practical guidance on the menu labeling requirements by the end of this year," said FDA spokeswoman Deborah Kotz.
Small businesses prefer that portions of the rule be rewritten or a legislative fix with the Common Sense Nutrition Disclosure Act of 2017.
The bipartisan bill sponsored by House Republican Conference chairwoman Cathy McMorris Rodgers (Wash.) is currently stuck in Congress after it passed the Energy and Commerce Committee in July.
The congressman also has concerns that guidance would not fix the regulation. The legislation provides greater flexibility, giving businesses where the majority of their orders are placed electronically the ability to comply with the regulation by posting calories online. The bill also fixes the definition of menu to only apply to the primary listing—and not advertisements—and would give businesses 90 days to correct any violation.
"Seeing the Common Sense Nutrition Disclosure Act over the finish line remains a top priority for the congresswoman," said Jared Powell, spokesman for Rep. McMorris Rodgers. "She too has questions over what, if anything from her bill, can be achieved through FDA guidance."
"Our goal is to move forward on a legislative fix to provide clarity for the small businesses in Eastern Washington and across the country who will be impacted by this burdensome rule," he said.
The groups are also concerned that guidance will not address the potential for frivolous lawsuits with the rule, like suing for mislabeling potato salad in a grocery salad bar.
"Store managers, and people behind a deli-counter who are trying to put information up, they're really nervous that somebody is going to come into their store and really cause problems," said Rosado. "Our guys get sued for what's called slip and fall stuff all the time."
"It's just one more avenue for frivolous lawsuits," said Reisch.
Rosado said in the midst of the Republican legislative agenda and other priorities of the adminsitration, he does not want the issue to be forgotten. "We don't live in a bubble. We know there's tax reform and other things going on," he said. "But we also don't want this to be left behind. It got off to a really good start. This administration is serious about fixing regulations."
"To me, this is an easy one to fix because we've brought the solutions to them," Rosado said.
Published under: FDA