Members of a House committee examining FDA's regulation of the food and tobacco industries had a question for the agency's representatives at a hearing Tuesday: Why aren't you going after big e-cigarette makers?
"On the enforcement side, it seems the FDA has chosen to focus on small actors," Rep. Brett Guthrie (R-Ky.), chairman of the House Energy & Commerce Health Subcommittee, said at a hearingopens in a new tab or window aimed at evaluating the agency's human foods program and its tobacco program. He noted that most of the civil monetary penalties that the Center for Tobacco Products (CTP) has issued so far related to selling unapproved vaping products have been levied on individual vape shops.
Action Across the Supply Chain
"We still have an overwhelming number of illicit products, and the vape shops shouldn't be selling them," said Guthrie. "But it seems like the major move that you can make to stop this is [against] the major manufacturers."
Rep. Troy Balderson (R-Ohio) agreed. "Why has the FDA continued to focus its efforts on small retailers rather than big manufacturers?" he said, adding that in some cases, the vape shops that had penalties levied against them were counted as manufacturers because they mixed the vaping liquids themselves.
Brian King, PhD, MPH, director of the CTP, acknowledged that some vape shops were indeed classified that way. But he said his agency "has taken action across the supply chain, and we've also taken escalated action in more recent years ... Any entity that does not have authorization is indeed subject to enforcement action, regardless of the size of the business."
Asked by Rep. Guthrie whether current enforcement was adequate, King responded that "I believe there's opportunity to enhance it ... but we don't have the resources to do it, particularly given that we aren't collecting any user fees for e-cigarettes and 90% of our enforcement dollars are being spent on that product."
Several committee members expressed doubts about increasing funding for the agency. "Congress has provided the FDA with substantial resources to effectively run [the human foods and tobacco] programs, yet the FDA is requesting millions more in budget authority ... while providing little information about how their current resources are spent, existing authorities are used, and regulations are being enforced," Rep. Cathy McMorris Rodgers (R-Wash.), chair of the full Energy & Commerce Committee, said in her opening statement. "I look forward to having this discussion today to better understand how existing resources and authorities can be better used to improve the safety and quality of our food supply and get the Center for Tobacco Products working after falling short for the last decade."
What Are the Results?
Rep. Michael Burgess, MD (R-Texas), asked King directly about his center's outcomes. "What have we gotten for this investment of over $2 million a day in your division? How many lives have been saved?" he asked. King said that smoking rates among adults have been cut in half since the center was given regulatory authority over tobacco. "My estimate is that tens of millions of lives have been saved," he said.
That wasn't good enough for Burgess. "When this bill [bringing the CTP into being] was passed over 10 years ago, the idea was, you are going to prevent youth from smoking in the first place," he said. "What programs are going on right now for $2 million a day that are preventing youth smoking from happening in the first place?"
King said the agency's prevention campaign, titled "The Real Cost," just celebrated its 10-year anniversary "and it has prevented tens of thousands of kids from starting to smoke," he said. "For every dollar we invest, we save $180 on tobacco-related disease and death."
Rep. Robin Kelly (D-Ill.) wanted to know why the CTP has been slow to finalize a rule that would outlaw menthol cigarettes; The Biden administration has delayed the final rule several times recently, saying it would be published in August 2023, then pushing that date back to the end of the year, and then saying it would be published this past March. In late April, HHS Secretary Xavier Becerra issued a statementopens in a new tab or window saying that the rule would take "significantly more time" given all the controversy surrounding it.
"I was deeply disappointed that the agency chose to abandon its established plan to ban menthol cigarettes," said Kelly, who is a member of the Congressional Black Caucus. She added that "72,000 Black Americans are diagnosed and 39,000 die from tobacco-related cancer each year. "
King assured her that the agency "has not abandoned the menthol product standard. Indeed, it's a priority for us. We followed the rulemaking processes, and it's presently with the White House, and it continues to be a priority for us."
Concerns About Milk Alternative Labeling
The agency's human food program also came under scrutiny, with several lawmakers in states with a large dairy industry expressing concern about plant-based milk alternative manufacturers being able to call their products "soy milk" or "almond milk."
Rep. John Joyce, MD (R-Pa.) touted a bill he sponsored, the DAIRY PRIDE Actopens in a new tab or window, which would prohibit the sale of any food that uses the market name of a dairy product (such as "milk," "yogurt," or "cream cheese") unless the food is the milk of a hoofed animal, is derived from such milk, or contains such milk as a primary ingredient.
"These standards of identity are critical as they establish common understandings for the American public as to what constitutes specific foods," Joyce said. "Consumers rely on these standards to infer a certain nutritional value based simply on how a product is labeled." He asked FDA Deputy Commissioner for Human Foods Jim Jones how the FDA views plant-based dairy substitutes that are currently being marketed and currently being sold in the dairy sections of supermarkets.
"The research that we've done on consumers [shows] that consumers are not confused [because] the plant-based alternatives are not milk -- as a matter of fact, they are purchasing them for exactly that reason, because they're looking for an alternative," said Jones. "That being said, our research also shows that consumers are not aware that oftentimes, plant-based alternatives to milk are not nutritionally equivalent to milk."
"So allowing it to be sold in the dairy case -- is that not misleading?" Joyce asked. Jones said that current agency guidance on the topic, which has been drafted but is not yet finalized, "encourages plant-based milk alternatives to identify nutritional equivalence, or lack thereof, on their product."
Joyce was not happy with that answer. "Simply urging companies to spell out a nutritional deficiency will not solve the problem of consumer confusion," he said. "Milk comes from a lactating mammal, and imitators, or fakes, are simply not milk."
Rep. Kim Schrier, MD (D-Wash.), a pediatrician, asked about the fragility of supply of specialty milk for infants with particular dietary needs. "As a pediatrician, I've seen firsthand the vulnerability and fragility of extremely premature infants," she said. "There's no question that the best and safest nutrition [for them] is breast milk ... But when there's no access to mom's milk, they sometimes have to be given specialized formula." She asked Jones about the impact of any potential for disruption of the specialty milk supply given that there are only two suppliers of the product.
"We are very concerned about the potential for one or both of the manufacturers to leave that market, for business reasons," said Jones. "Secretary Becerra has asked our colleagues at the NIH to pull together a group of experts, neonatologists, and others to give him a report about the risks and the benefits associated with these products. That report is due to the secretary next week."
https://www.medpagetoday.com/publichealthpolicy/fdageneral/111892
