Tag: Regulation

According to the U.S. Food and Drug Administration (FDA), there are over 20,000 distinct prescription drug products available for marketing in the United States, yet this number is a moving target and represents a much more complex reality than a single count can capture. Understanding how many approved drugs are on the market requires distinguishing between active ingredients and the numerous product variations available.

In 2023, Dechlorane Plus was added to Annex A of the Stockholm Convention for global elimination, highlighting its significant toxicity and environmental persistence. But before its recent prohibition, what is Dechlorane Plus used for, and why did it become such a widespread concern?

The U.S. Food and Drug Administration (FDA) has only approved one purified CBD drug for specific seizure conditions, named Epidiolex. This fact highlights the critical distinction between regulated medication and consumer products when answering the question: **Do CBD gummies count as drugs?**.

Due to ongoing concerns about its effects and addiction potential, kratom is illegal in many countries worldwide. The question of **where is kratom banned in the world?** reveals a complex legal landscape, with strict prohibitions in some nations and a patchwork of regulations in others.

While the legality of cannabis has been a major topic of discussion in recent years, the retail landscape for kratom is significantly different, and the question, "Is kratom sold in dispensaries?" does not have a simple yes or no answer. In the United States, kratom is not federally regulated as a medication or dietary supplement, which results in a patchwork of state and local laws governing its sale and distribution.

In the late 19th century, cocaine was a common ingredient in patent medicines, beverages like Coca-Cola, and other products sold without regulation, illustrating a stark contrast to its current illegal status. The history of this substance serves as a potent example for the question: what is an example of a drug that was once legal in the United States but now is not?.

Dexamethasone, a potent corticosteroid used to treat a wide array of inflammatory and autoimmune conditions, is exclusively a prescription-only medication in the United States and many other countries. This means you cannot simply walk into a pharmacy and buy dexamethasone over the counter, a restriction placed due to the drug's powerful effects and potential for serious side effects.

Established in the early 1990s to harmonize pharmaceutical oversight, EudraLex is the official compilation of rules governing medicinal products within the European Union (EU). This extensive collection of legislation and guidelines is mandatory for any company seeking market access in the EU pharmaceutical ecosystem, ensuring products meet stringent safety, efficacy, and quality standards.

Unlike prescription medications, dietary supplements like ashwagandha are not subject to pre-market approval by the U.S. Food and Drug Administration (FDA) for safety or effectiveness. This means that while the FDA regulates the manufacturing and labeling of these products, it does not certify that they are safe or that they work as claimed before they are sold to the public.