Tag: Regulatory status

In 1993, the FDA officially banned betaine hydrochloride from being sold in over-the-counter (OTC) medications, a decision that has created widespread confusion ever since. The question, "Is betaine HCL banned by the FDA?" continues to be asked by consumers who see it readily available in health food stores. This article will clarify the legal and regulatory landscape surrounding this supplement.

According to a 2020 re-evaluation by the European Food Safety Authority (EFSA), the safety of potassium aluminium silicate (E555) as a food additive could not be definitively assessed due to a lack of sufficient data. This critical finding leaves many consumers questioning: Is potassium aluminium silicate safe to eat, and what are the potential risks?

According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements are classified as a special category of food, not drugs. This classification determines their regulation and distinguishes them from conventional food, which offers a complex mix of nutrients and serves as a primary source of nourishment.

According to the U.S. Food and Drug Administration (FDA), D&C Red No. 33 is a certifiable color additive that is indeed approved for specific uses in drugs and cosmetics, subject to strict regulations and quantity limits. This regulatory status differentiates it significantly from the recently banned color additive, FD&C Red No. 3.

In a major 2025 regulatory turnaround, the FDA officially reversed its 2022 stance that temporarily restricted NMN supplements from being sold on mainstream US marketplaces. This decision, which followed pressure from industry groups, clears up the confusion for consumers wondering why they couldn't find NMN and restores its legal status as a dietary supplement.

According to the European Food Safety Authority (EFSA), anti-caking agent 551, or silicon dioxide, is safe for consumption at current use levels. Despite this, a 2024 study linking the additive to potential intestinal inflammation and celiac disease in mice has raised significant public concern and prompted a closer look at its health implications.

Over 38,000 food products contain Red Dye 40, also known as Allura Red. While regulatory bodies approve its use, a growing body of research and public concern asks: **Is allura red bad for you?**.

Following a landmark decision by the U.S. Food and Drug Administration (FDA) on September 29, 2025, which confirmed that NMN is lawful for dietary supplements, the regulatory uncertainty surrounding this popular molecule has been lifted. The question, 'Can you buy NMN in the US?' now has a definitive and positive answer for consumers and retailers alike.