Not every product being sold on shelves is safe for everyone to use. That’s why warning labels are extremely important, as they let us know about the risks that might be associated with certain items—and if those risks apply to us. Unfortunately, labels can also be misleading: The U.S. Food and Drug Administration (FDA) is now alerting shoppers that the supplements or food they are buying could be unsafe if the packaging includes two specific words. Read on to find out what you should watch out for when shopping.
In the interest of public health and safety, the FDA is responsible for regulating a number of products consumers use, including food and dietary supplements. But unlike most of the medicines you see on the market, the agency doesn’t have to approve food products and supplements before they’re sold to the general public. According to the FDA, it does not have premarket approval (PMA) for either of these, except under certain instances.
PMA “is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness” of certain products before they’re marketed and sold to consumers, the agency explains. This four-step approval review process is the “most stringent” type of marketing application required by the FDA.
In a May 10 consumer update, the FDA alerted shoppers to look out for these two words on supplements and food products: “FDA Approved.” According to the agency, some companies try to use this phrase on their website, commercials, or packaging for a product, even when the product did not receive approval from the FDA before being put on the market.
“The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation,” the agency explained. “But not all those products undergo premarket approval—that is, a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already for sale.”
When it comes to food, many products do not have to gain FDA approval before being sold to shoppers. The agency doesn’t approve food products, individual food labels, medical foods, or even infant formula. “Any statements on food products must be truthful and not misleading—and must comply with any regulatory requirements for the type of statement, as applicable,” the FDA warned.
But there are some exceptions for additives in food. The FDA said it does have the authority to approve certain ingredients before they’re used in food, which includes food additives and color additives. Companies looking to add new food additives or color additives to food are responsible for providing the FDA with information that demonstrates the additives are safe, and the agency will evaluate this safety data for approval.
“Certain food ingredients, such as those that are considered ‘generally recognized as safe’ (GRAS) for their intended conditions of use by scientific experts, do not require premarket approval by the FDA,” the agency further explained. “The FDA has a voluntary notification process under which a manufacturer may submit a conclusion that the use of an ingredient is GRAS.”
According to the FDA, companies manufacturing dietary supplements are responsible for ensuring that their own products are safe before marketing and selling them, but they don’t have to seek approval from the agency beforehand. “The FDA is not authorized to approve dietary supplements for safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA,” the agency warned.
The only exception for this is that companies trying to sell supplements that contain new dietary ingredients (NDIs) must submit a premarket safety notification to the FDA at least 75 days before marketing their product. Even in this case, however, the supplement can’t be said to be “FDA Approved.” Only once a supplement is being sold can the agency act against it if public health concerns arise about the safety of the product or an ingredient in it.
“The FDA’s logo is for official government use only. The FDA’s logo should not be used to misrepresent the agency or to suggest that the FDA endorses any private organization, product, or service,” the agency concluded.