The vitamin and supplement markets remain heavily regulated in the United States, largely due to the Dietary Supplement Health and Education Act of 1994 (DSHEA). Therefore, entrepreneurs in this market must understand it and how it affects their business.
Let’s take a look at the Act.
Dietary Supplement Health and Education Act of 1994
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is a United States law that defines dietary supplements, classifies them as foods rather than drugs, and outlines the regulatory process by which dietary supplements are manufactured, marketed, and sold. The law also requires dietary supplement labels to carry a disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease.
DSHEA was signed into law by President Bill Clinton on October 25, 1994, and went into effect on December 12, 1994.
Why it Was Necessary
DSHEA was a direct response to increased consumer demand for dietary supplements and vitamins in the early 1990s. The act deregulated the supplement industry, giving companies more freedom to produce and market their products. Therefore, it was seen as a way to promote free enterprise and protect consumer choice.
How it Impacts Companies Today
The dietary supplement industry has grown exponentially since DSHEA was enacted, with sales reaching $32 billion in the United States in 2011. The act has also been credited with creating an industry that is now largely self-regulated.
However, companies must still comply with certain regulations regarding manufacturing, labeling, and safety. In addition, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) can take action against companies that make false or misleading claims about their products.
How It Impacts Your Company
If you are considering starting a dietary supplement company, it is important to be aware of DSHEA and how it affects your business. You will need to adhere to the labeling requirements set forth in the law, and you should be familiar with the manufacturing and marketing regulations. For example, you cannot make false or misleading claims about your products. You will also need to ensure that your products are safe for consumers.
To comply, you will likely need to work with a dietary supplement manufacturer familiar with DSHEA and can help you navigate the regulatory landscape. Some steps you’ll need to take are:
- Get approval from the FDA for your dietary supplement’s manufacturing process.
- Ensure that your dietary supplement labels comply with FDA regulations.
- Make sure your dietary supplement is safe for consumers.
To obtain FDA approval, you must submit a New Dietary Ingredient Notification (NDIN) for each dietary ingredient in your product. The notification must include information about the safety of the ingredient.
The FDA also regulates dietary supplement advertising. All claims made about a dietary supplement must be truthful and not misleading. In addition, before making any claims about the health benefits of a dietary supplement, you must have scientific evidence to back up those claims.
You will also need to ensure your dietary supplement is safe for consumers. This includes doing safety testing and ensuring that your manufacturing process meets FDA standards.
Conclusion
DSHEA has profoundly impacted the dietary supplement industry, making it possible for companies to produce and sell their products with relatively little government oversight. If you are considering starting a dietary supplement company, you must be aware of DSHEA and how it affects your business. Once you satisfy all the requirements, you will enter a booming market.