FDA orders food companies to disclose when new ingredients are added to products

FDA on Monday proposed a new rule that would require food companies to inform the government when they add new ingredients to their products, removing a voluntary notification program often criticized by food safety experts.

For years, food and beverage companies have been permitted to introduce new ingredients without FDA review by asserting the ingredients are "generally recognized as safe," a designation known as GRAS.

The policy was initially implemented to allow companies to forgo review for common ingredients like baking soda and flour, but companies have used it to introduce at least 1,000 substances to the U.S. food supply — including thickeners, extracts, and flavorings — without much evidence that they're safe.

Under the new proposed rule, companies would be required to inform FDA about new ingredients they intend to use and submit data showing those ingredients are safe. Officials said they would also create a "streamlined review process" for ingredients that are already on the market, requiring companies to tell FDA which food chemicals they're already using and how they're using them.

"We don't even know exactly how many chemicals are in the food that Americans eat every day, and the food industry continues to develop novel compounds and chemical combinations that do not exist in nature," said HHS Secretary Robert F. Kennedy Jr. "Our bodies did not evolve consuming many of these substances, and that makes rigorous science and transparent safety review even more important."

According to acting FDA Commissioner Kyle Diamantas, companies would not be blocked from entering the market before notifying FDA, but he added that the notifications are "mandatory." Under the rule, if companies don't submit notices, their substances could be prioritized for scrutiny by FDA.

Peter Lurie, president of the Center for Science in the Public Interest, said it's unclear if that would be enough incentive to get companies to comply, and added that enforcement would be difficult, which in effect makes the new rule "voluntary."

(Whyte, Wall Street Journal, 8/10; Callahan/Blum, New York Times, 8/10; Reed, Axios, 8/11)

Senate panel votes to hold Fauci in contempt of Congress

The Senate Homeland Security Committee on Thursday voted 8-5 along party lines to hold former National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci in contempt of Congress for declining to answer questions during a hearing last month investigating the origins of the COVID-19 pandemic.

During the hearing, Fauci invoked the Fifth Amendment and declined to answer any questions, a decision that Homeland Security Chair Sen. Rand Paul (R-Ky.) said was "unsupported" since former President Joe Biden preemptively pardoned Fauci before leaving office. However, Fauci argued that making any new statements that potentially open new lines of investigation could get him in trouble.

Following the vote to hold Fauci in contempt of Congress, Paul said he would be referring the contempt resolution to the Department of Justice for possible prosecution.

In a social media post last week, Sen. Ron Johnson (R-Wis.). who leads the Senate Homeland Security Permanent Subcommittee on Investigations, said the panel "has obtained a copy of Dr. Fauci's phone from [HHS]."

Fauci used the phone during his time as director of NIAID and turned the phone in when he retired, according to a person familiar with the matter who spoke to the Wall Street Journal.

On Monday, Paul and Johnson released a series of texts from Fauci's phone, including an exchange between Fauci and top health officials in January 2021 related to the safety of the COVID-19 vaccine for pregnant women.

In the exchange, Fauci wrote: "Since many people have significant cytokines storm and fever after the 2nd dose, this theoretically could be associated with miscarriage in the 1st trimester."

In response, then-CDC Director Rochelle Walensky said, "Definitely a good point, esp after dose two."

Johnson and Paul pointed to several public statements from Fauci and other health officials stating the benefits of pregnant women getting vaccinated appeared to outweigh the risks. Johnson said the release of the texts "could have an immediate impact on public health," adding that "you don't wait a day, months, or years, to inform the public of potential dangers."

According to CDC, over a million pregnant women have been vaccinated against COVID-19 globally, and research has not shown an increased risk for complications like miscarriage, preterm delivery, and more. Health officials also noted that such past exchanges reflect the evolving nature of the science and debate at the time.

(Stolberg, New York Times, 8/6; Bettelheim/Nather, Axios, 8/6; Whyte/Siddiqui, Wall Street Journal, 8/6; Chamberlain, New York Post, 8/6; Liss-Roy/Roubein, Washington Post, 8/10)

Currently, the preservative is present in "a small percentage of flu vaccines, confined to multidose vials," according to the Vaccine Integrity Project. Kennedy has aimed to remove the last-remaining shots containing thimerosal in the United States, and the departments said the Trump administration "believes reducing reliance on mercury-containing vaccines, where suitable alternatives are available, is a pro-vaccine, pro-innovation policy."

Gavi provides vaccines for 20 diseases — including measles, malaria, and polio — to more than 50 low-income countries around the world. It estimates that it has vaccinated over 1.2 billion children in the world's poorest countries, preventing more than 20.6 million potential deaths. U.S. funding represents around 15% of Gavi's total yearly budget.

(Paun, POLITICO, 7/29)

CMS proposes new restrictions on provider taxes that help fund Medicaid

CMS last month proposed a new regulation that would pare back provider taxes, which states apply to hospitals, Medicaid managed-care companies, and others to help finance the state's share of Medicaid spending.

Reduced provider taxes were enacted as part of the One Big Beautiful Bill Act (OBBBA), some of which were finalized by CMS in a January rule.

Under previous regulations, a provider tax policy was allowed if it was broad-based and uniform and if it didn't permit providers to be repaid the taxes they contribute, which is known as a "hold harmless" provision.

Before OBBBA, the "hold harmless" provision didn't apply as long as state tax revenues didn't exceed 6% or less of providers' net patient revenues. However, OBBBA requires that threshold to be reduced over time in Medicaid expansion states.

Starting Oct. 1, all states are prohibited from implementing new provider taxes or from increasing ones in effect as of July 4, 2025, when OBBBA was signed into law. The current "hold harmless" system would be replaced by specific thresholds for providers and states based on taxes that were effective on July 4, 2025.

The new proposed rule would reduce the indirect hold harmless threshold by 0.5 percentage points each year from 2028 to 2032 when the thresholds hit 3.5%. It would also clarify definitions of which taxes were in effect as of July 2025, adjust the formula CMS uses to assess whether a provider tax could remain permissible, and require increased provider tax data reporting.

In addition, the rule proposes the establishment of Medicaid insurers as a permissible class for healthcare tax-related purposes, which CMS said would bring states' existing insurer taxes under the agency's oversight.

(Early, Modern Healthcare, 7/21)