Policy & Regulation

The FDA has announced a major plan to revisit the safety of 10,000 food additives, starting with controversial chemicals found in products like bread, cereals, and preserved meats.

The FDA has launched a new initiative to systematically review 10,000 food chemicals currently used in the U.S. food supply, aiming to improve transparency and safety.

The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, Nuvaxovid, but with significant usage limitations.

In a significant move, the U.S. Food and Drug Administration (FDA) has announced plans to intensify its oversight of chemicals in the U.S. food supply, transitioning from a historically reactive role to a more proactive evaluation process.

On May 12, 2025, the US Food and Drug Administration (FDA) issued rule 2025-08249, amending the color additives exempt from certification list to approve Calcium Phosphate as a color additive.

In a major breakthrough published on April 30, 2025, in The New England Journal of Medicine, semaglutide has emerged as a promising treatment for metabolic dysfunction–associated steatohepatitis (MASH)—a severe liver condition formerly known as NASH.

On May 8, DOMO Chemicals announced a significant expansion of its composite materials operations in Mumbai, solidifying its role as a key supplier of high-performance solutions in the region.

In Kosovo, the diabetes medication Ozempic has become a popular weight-loss solution, despite serious health warnings and regulatory concerns.

The European Union’s ambitious environmental regulations are imposing a staggering $20 billion annual cost on the chemical industry, according to the European Chemical Industry Council (CEFIC).

On April 22, 2025, the European Commission officially adopted Regulation (EU) 2025/756, granting market authorization for L-valine produced by Escherichia coli CGMCC 22721 as a feed additive for all animal species.

The U.S. Food and Drug Administration (USFDA) has issued a warning letter to Aspen Biopharma Labs for significant violations at its active pharmaceutical ingredient (API) manufacturing plant in Rangareddy, Telangana.

On April 10, 2025, the European Commission officially adopted Regulation (EU) 2025/688, tightening the rules for the novel food FCC-3204 oil, derived from the Schizochytrium genus.

Indian pharmaceutical company Zydus Lifesciences has received final approval from the US Food and Drug Administration (US FDA) for Jaythari (Deflazacort) tablets.

Aurobindo Pharma has announced that the US Food and Drug Administration (USFDA) issued a Form 483 with 11 observations to its Raleigh plant in North Carolina, operated by its subsidiary Aurolife Pharma LLC.

Indian pharmaceutical giants like Dr Reddy's Laboratories, Zydus Lifesciences, and MSN Labs are racing to produce generic versions of the blockbuster weight-loss drug semaglutide as the first patent for the medication expires in March 2026.

In March 2025, the U.S. FDA refused the importation of multiple batches of food products from China.

Recently, the FDA announced the official revocation of the use of erythrosine (FD&C Red No. 3) in food and ingestible drugs. This ban, which began with cosmetics, has gradually expanded to food and pharmaceuticals over several years.

Taiwan Food and Drug Administration (FDA) released a list of non-compliant foods at its borders, revealing that a batch of banana chips from Indonesia was found to have illegally added sweeteners.

U.S. Food and Drug Administration (FDA) published document 2025-04034, proposing amendments to the regulations governing color additives.

U.S. Environmental Protection Agency (EPA) announced regulation number 2025-04707, which exempts Potassium Polyaspartate from residue limits under specific conditions.