Tag: Regulation

According to the National Center for Complementary and Integrative Health (NCCIH), the use of probiotics by U.S. adults quadrupled between 2007 and 2012. While their popularity soars, the key question remains: are there any FDA approved probiotics? The answer involves a critical distinction in how the FDA regulates products based on their intended use, a fact often misunderstood by consumers.

In late 2022, the FDA reclassified Nicotinamide Mononucleotide (NMN), revoking its status as a dietary supplement and causing major retailers like Amazon to cease sales. However, despite this regulatory change, you can still buy NMN in the USA today from various online and specialty retailers, albeit with ongoing market uncertainty.

Less than 1% of dietary supplements are subject to mandatory pre-market review by the FDA, a process required for prescription drugs. This regulatory distinction is key to understanding what the FDA says about Nugenix, an over-the-counter testosterone booster.

While most over-the-counter (OTC) and prescription eye drops are not controlled substances, the U.S. Drug Enforcement Administration (DEA) has previously classified certain ophthalmic products, such as cocaine eye drops, as controlled drugs. The controlled status is dependent on the specific active ingredient, its potential for abuse, and its accepted medical use.

Despite the common belief that cannabidiol (CBD) is entirely non-intoxicating, a significant number of consumers report feeling a subtle 'buzz' or mild euphoric effect after use. The scientific reason behind this phenomenon is not the CBD itself, but rather a result of other compounds, primarily delta-9-tetrahydrocannabinol (THC), present in improperly manufactured or specific types of CBD products.

According to a 2021 study, most delta-8 users reported relaxation and pain relief with fewer adverse effects like anxiety or paranoia compared to delta-9 THC. However, determining if delta-8 is worse than delta-9 involves looking beyond user experience to consider critical differences in manufacturing, regulation, and overall safety risks.

The U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety or effectiveness before they are marketed. This critical distinction is key when asking, 'Is Recell supplement FDA approved?', as there is public confusion between a legitimate, FDA-approved medical device called the RECELL® System and unapproved products marketed as supplements.

According to a September 2025 update from the Mayo Clinic, in the United States, EMLA cream is available only with a doctor's prescription. However, the rules regarding **do I need a prescription to buy EMLA** are not the same globally, with regulations varying significantly from country to country. It is crucial to understand local laws and consult a healthcare provider to ensure safe and legal access to this medication.

After a period of removal in 2021, Amazon resumed sales of N-acetylcysteine (NAC) supplements in August 2022 following final guidance from the U.S. Food and Drug Administration (FDA). This confirms you can buy NAC on Amazon again, but its availability has been subject to specific regulatory changes.

The FDA issues numerous guidance documents annually to help regulated industries, including those in pharmacology, understand the agency's current thinking. A specific type, a Level 2 FDA guidance, is distinguished by its less complex nature, focusing on existing practices and minor policy adjustments.