484 Lake Park Avenue, #332 Oakland, CA 94610 info@Michaellangefoundation.org (510) 455-4040

FDA Approval?

Written by: Matthew Perry

Edited by: Ally Bowles

The United States Food and Drug Administration (FDA) is one of the most prominent agencies in the federal government. The FDA is the overseer of Over the Counter Drugs (OTC’s) and prescription drugs, and states that consumer protection is the primary public health mission (FDA Basics). OTC medications are drugs that can be purchased by the consumer without a prescription. These drugs can be marketed without FDA pre approval as long as the active ingredients conform to their monograph. The monograph is a bank of medications that are generally recognized as safe and effective (Regulation of Nonprescription drugs). Therefore, any drug put in a particular category has a formula that is recognized as safe by the FDA in terms of composition and dosage. However, although these standards seem on the surface to be stringent, as long as the chemical composition is the same and there is a standardized label of active ingredients, warnings and other information typically seen on the back of a medication box, the medications may remain unsupervised by the FDA. The un-regulation of OTC products can become potentially hazardous, especially when the FDA claims that “there are over 300,000 marketed OTC drug products…[and]…instead of individual drug products, the FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs” (FDA frequently asked questions).

This does not mean that anyone can market cyanide as a pain reliever because pain relief is not this chemical’s intended purpose. However, what it does mean is that with little regulation and without any testing whatsoever from the FDA (FDA frequently asked questions), anyone could put their aspirin in a type of packaging that chemically reacts with the medication potentially rendering the product either toxic, diminished, or useless. This seems like a trivial and unlikely scenario, however, if a person is taking aspirin for a heart condition and regularly relies on the blood thinning abilities of aspirin to keep them alive, then this packaging and medication interaction could put the person in a position where they are either regularly ingesting a toxic substance, or unknowingly not receiving the full dosage to keep their heart condition under control. This is one of the many latent consequences of not testing every, or at least most, drugs that are on the market.

The next time you see the term FDA approved, and it gives you comfort, think again, because it is only the class of active ingredients and color additives in your medication that has been seen as generally safe, and not necessarily the entire contents of the OTC medication you are taking. It is also important to note that “If [the] FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use” (“Is It Really FDA Approved?” FDA’s consumer updates article). This means that the medication you take are not certainly intended to be healthy for your body, it is only potentially less destructive than the side effects. This process of unregulated products becomes even more concerning when it comes to cosmetics, soap, dietary supplements and compound drugs. I will be diving into some of these issues in my upcoming articles.
For more Information, click on the links below:

FDA Basics

FDA frequently asked questions

FDA Monograph Information

“Is It Really FDA Approved?” FDA’s consumer updates article

Mandated Labeling for all FDA OTC medications

Regulation of Nonprescription drugs

Leave a Reply

Your email address will not be published. Required fields are marked *