It is not uncommon for people to take notice on product labels, company websites, commercials promoting a new product or treatment or hear some marketers saying the word’s “FDA approved!” What does that even mean and is it really FDA approved? How can you know for sure what the US Food and Drug Administration approves? This article focuses on tobacco and color additives and subsequent articles will look at how the FDA regulates products and what it does and doesn’t approve.
FDA does not approve tobacco products
The fact of the matter is that there is no such thing as a safe tobacco product. Therefore, the FDA’s safe and effective standard for evaluating medical products is not appropriate for tobacco products. Instead, the FDA regulates tobacco products based on public health standard. This considers the product risks to the population as a whole.
To legally sell and distribute a new tobacco product in the U.S, manufacturers must receive a written order from the FDA. To bring a tobacco product to market a manufacturer can choose one of three ways:
- Pre-market tobacco applications
- Substantial equivalence applications, or
- Exemption from substantial equivalence
It must be noted that the marketing order does not indicate that the tobacco product is either safe or approved. It simply means that the manufacturer has complied with the requirements under the law to bring its products to market.
FDA approved color additives used in FDA regulated products
The color additives approved by the FDA include those used in:
- food – including animal food
- Dietary supplements
- Cosmetics, and
- Some medical devices
These color additives are subject by law for approval by the FDA, except coal-tar hair dyes. Such food additives must be used only in compliance with its approved uses, specifications and restrictions. The FDA evaluates safety data in order to ensure that a color additive is safe for its intended use.