As you may have noticed while browsing our website, we frequently footnote our pages with the disclaimer “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
We are extremely well-acquainted with this phrase because we have written it so many times, but for a newcomer to our website, the disclaimer may seem a little suspicious. Fortunately for us, there is nothing unusual about the statement or its placement on our page. It is simply a reminder of the FDA’s role in the vitamin/supplement industry. Essentially, it clarifies that–as far as the Administration is concerned–vitamins, supplements, and Chica are technically foods instead of medicine.
As the name implies, a “supplement” is a “product taken by mouth” containing a dietary ingredient which is meant to supplement what you’re already eating (FDA 101: Dietary Supplements). These ingredients can take the form of vitamins, minerals, amino acids, herbs or botanicals, etc. And they are defined separately from drugs because supplements support your body’s natural functions instead of chemically altering them.
But why does the FDA care about supplements?
The short answer is that it’s the Food and Drug Administration’s job to care about what US consumers are putting on and in our bodies. This includes supplements. However, the FDA monitors the different spheres of its jurisdiction (i.e. food and drugs) very differently. Before a drug is released to market, the manufacturers must prove to the FDA that their product has been found effective in clinical trials and is safe to consume for its intended use. Food vendors are not required to do so (consider how their products have less potential to be fatally dangerous).
Vitamins and supplements must still comply with the FDA’s regulations, which ensure that the manufacturer is following food safety guidelines and providing clear supplement information. But the FDA itself does not approve nutritional products for sale. Instead, the companies intending to sell a non-pharmaceutical product are held accountable for ensuring that their own product works and can be safely consumed. For a product like Chica, we rely on extensive previous clinical research–as well as expertise from a licensed acupuncturist–to validate the efficacy/safety of our formula.
This may seem like a harsh binary that ignores the health benefits of natural medicines, but from a regulatory standpoint, it would be incredibly inefficient for the FDA to attempt to regulate supplements and pharmaceuticals using the same rulebook. Mineral and plant-based medicines are not a new or trendy practice–evidence of plants and other natural substances used as healing tools can be traced back to the earliest human civilizations–but the evolution of dietary supplements as a distinctly regulated purchase category is more recent and has a lot more to do with the history of drugs and disease in the US.
The FDA identifies its own origin as the passage of the Pure Food and Drugs Act in 1906. Prior to this law, there was no federal standard for the contents and sale of domestically produced food and pharmaceuticals, and a lot of people died or contracted severe illnesses as a result of ingesting poisonous or misbranded products. However, it wasn’t until the late 1930’s, when at least 100 deaths were blamed on a pharmaceutical manufacturer that had introduced a toxic and untested solvent to the market under the title “elixir,” that the government started to actually enforce this standard created by the early FDA. In response to the health scandal, President Roosevelt signed the Food, Drug, & Cosmetic Act (FD&C Act) into law in 1938, and this authority evolved into what is now a “comprehensive consumer protection agency” meant to monitor the spectrum of consumer products (from makeup to tobacco) relevant to public health.
Chica Chocolate is subject to FDA regulation in two realms: as a dietary supplement used in “complementary and alternative medicine,” and as a food itself. Under the FD&C Act, both of these categories are defined as nutritional rather than medical. As such, products like ours cannot claim to diagnosis, treat, cure, or prevent disease of any kind (this was specified in 1994 with another law called the Dietary Supplement Health and Education Act (DSHEA)). This is why we use phrasing like “nourishes hormonal health,” and emphasize the long-term and holistic benefits of our formula.
This is not to imply that supplements do not work, or that they are so recklessly unregulated that they are unsafe for consumption. The FDA still closely monitors manufacturing, labeling, and distribution processes, and if a company does not comply with regulation, they will not be permitted to distribute their product to customers.
By providing a more detailed explanation of the FDA’s disclaimer & role in regulating our industry, we hope to create an environment of trust and transparency where everyone who visits our website can feel confident that we are offering a credible and high quality product created with a lot of integrity. We intend to provide you with all the tools you need to make an informed and enthusiastic decision about supporting balanced hormones and enjoying an easier period. Please reach out to us if you ever have any questions about Chica Chocolate!
Cassidy & Elise