Americans love to gripe about ridiculous-sounding regulations. We scoff at state rules that bar kids from running lemonade stands without proper permits and federal code that makes it a crime to sell earplugs when their noise-reduction rating isn’t written in a particular font (Helvetica Medium, for the record). There is even a popular twitter account, @CrimeADay, that churns out mentions of absurd-sounding regulations on a daily basis.
Certainly, not all laws are equally enforced, nor do they affect us all in the same ways. Yet once a rule is on the books it can have real consequences for individuals, businesses and communities—as can the delay or lack of clear requirements. Scientific American has looked into a suite of health-related federal regulations and guidance actions—including some that could affect tobacco use and food safety—that are likely to advance or stall out in 2018.
- Say hello to nonaddictive cigarettes? Imagine buying a pack of smokes so light on nicotine that they are unlikely to create addiction. They would still have all the flavorings, chemicals and additives of old, yet they would have extremely low levels of the core ingredient that helps fuel smokers’ attachment to cigarettes at a chemical level. The U.S. Food and Drug Administration says such a change would help tamp down smoking rates that kill more than 480,000 people in the U.S. each year. FDA Commissioner Scott Gottlieb has said his agency is taking its first step toward that future. By the end of this year, he has said, it will release a formal request for public input on lowering nicotine in cigarettes. That document is currently with the Office of Management and Budget for review, and will then be published in the Federal Register.
Lower nicotine levels could reduce new addictions and help currently hooked people quit, according to the FDA. Such a move was proposed decades ago but never took off—and will face significant opposition from tobacco companies. And if it does get the green light, officials will have to determine an acceptable nicotine level. “The best data we have suggests a nonaddictive level would be 0.5 milligrams in a cigarette, so that’s like a 95 percent or more reduction,” says Neal Benowitz, a professor of medicine at the University of California, San Francisco. Nicotine can be reduced via several techniques such as crossbreeding, genetic engineering or supercritical extraction—a process sometimes used to separate caffeine from coffee beans—says K. Michael Cummings, an expert in health behavior and tobacco research at the Medical University of South Carolina.
- It’s time to judge chemical safety. Last year Congress revamped the decades-old Toxic Substances Control Act, which regulates thousands of chemicals. But in order to manage those substances the U.S. Environmental Protection Agency must now decide what levels it will consider harmful to human health and the environment. As a first step, in 2018 the EPA will start releasing risk assessments for 10 priority chemicals including asbestos and a dry-cleaning substance called trichloroethylene as well as a dye called Pigment Violet 29, which is used in paints, inks and pharmaceuticals. (All 10 risk assessments are due by 2019 and will be published in the Federal Register.)
Deciding the official cutoffs for each chemical will be controversial. For example, a big question will be whether or not to count background levels of each substance that have accumulated in the past when there were no regulatory limits, says Rena Steinzor, a professor at the University of Maryland Carey School of Law and a member scholar the Center for Progressive Reform, a nonprofit organization that focuses on health and safety. Then there is the contentious fact that a top official responsible for these risk assessments is Nancy Beck, a scientist who, for many years, worked for the chemical industry at the American Chemistry Council. The Trump administration controversially granted her a special status exemption, sidestepping restrictions that would otherwise keep her from regulating or working with her former employer or clients for two years.
- Stop your DIY gene editing. Last month the FDA issued a tersely worded warning to anyone thinking of trying gene editing at home: Don’t do it. This came after a software engineer injected himself with an experimental gene therapy for HIV while streaming it live on Facebook this past fall. Selling such unproved therapies is already against the law, the FDA notes. But the agency does not typically step in when individuals engage in such “biohacking.” All it has said so far about individual use is that “consumers are cautioned to make sure that any gene therapy they are considering has either been approved by the FDA or is being studied under appropriate regulatory oversight.” This may be an area to watch for further action in 2018, says Adam Thierer, a senior research fellow at the Mercatus Center at George Mason University.
- Guidance! Get your guidance here! In Pres. Donald Trump’s first address to Congress, he promised to seek sweeping cuts to restrictions on business. “We have undertaken a historic effort to massively reduce job-crushing regulations, creating a deregulation task force inside of every government agency; imposing a new rule, which mandates that for every one new regulation, two old regulations must be eliminated; and stopping a regulation that threatens the future and livelihoods of our great coal miners,” Trump told lawmakers.
And regulatory affairs experts say it is likely the number of regulations coming out of federal agencies will be slow in 2018—partly due to the administration’s decreased agency budgets and its belief that there should be far less federal rulemaking and also because technological advances often outpace policy. As a result, Thierer says there will likely be more “informal consultations” between agencies like the FDA and companies with questions. He adds we should also expect the release of more guidance documents that spell out what agencies are worried about and what they do not plan to regulate—effectively deregulating items or practices without formal rulemaking.
In response to a list of detailed questions on this and other regulatory issues the FDA wrote to Scientific American in an e-mailed statement: “The FDA has put forth a robust policy agenda to advance our public health mission in 2018. Over the next year we will tackle many of our priority areas through both regulations and guidance documents, determined based on the best and most appropriate path.”
- Food label makeover? Not so fast. A revamped nutrition label was slated to debut on food packages in July 2018 but in September the Trump administration announced companies could have another couple years to comply with this requirement. Big food companies will have until January 2020 and smaller ones until January 2021. The new labels were approved by the FDA in May 2016. They offered more detailed information about “added sugar” versus natural sugar and easier-to-read information on calorie counts, among other changes. Critics say the new extension represents a major blow to public health and the fight against obesity.
- Action to stabilize the health insurance market. In the early years of the Affordable Care Act (aka Obamacare) the Department of Health and Human Services was kept busy issuing and implementing regulations to support the monumental health care law, notes Wendy Parmet, faculty director of the Center for Health Policy and Law at Northeastern University. Now the tax bill has a provision that removes the insurance mandate and once it becomes law, as expected, then lawmakers may have to follow up with some sort of actions to stabilize the market, potentially leading to new regulations from HHS.
- Repealing a major Obama-era carbon emissions rule? In August 2015 the Clean Power Plan was announced by the White House. This EPA policy required power plants fueled by coal and natural gas to significantly slash their carbon dioxide emissions. But this past fall the Trump administration said it would repeal this regulation—a move experts said would make it difficult to cut power emissions or meet Paris climate accord requirements. The change was open to public comments through December 15 and elicited more than 150,000 submissions. The agency will review that feedback in the coming months. But it is also moving forward with its next steps: On Monday, the administration started asking for public comment on what a replacement rule for the plan should look like.
- Bonus: State action to improve health and safety. States and cities may take up their own regulatory actions, too. Areas to watch include more possible soda and cigarette taxes, already imposed in a handful of jurisdictions. Cities may also seek to reduce pedestrian deaths via programs similar to New York City’s “NYC Safe”—an initiative that changed zoning and speed laws and required more barriers between pedestrians and cars, notes Lawrence Gostin, the director of the O’Neill Institute for National and Global Health Law at Georgetown University. “We often think of public health as being about infectious disease and obesity,” he says, “but road traffic injuries and deaths are part of this, too, and they are very amenable to regulatory prevention.”