• February 2, 2022

Is It a Food? A Dietary Supplement? A Drug? Why It Matters

Is It a Food? A Dietary Supplement? A Drug? Why It Matters

Is It a Food? A Dietary Supplement? A Drug? Why It Matters 700 500 Suzie Trigg

At SKU, we often get questions about what can and should go onto a brand. To get some answers, we turned to attorneys Suzie Trigg and Tony Subketkaew at Haynes Boone.

Early decisions about what a CPG company really sells – food, dietary supplements, or both – matter because they help the company avoid reformulation, relabeling, costly lawsuits, or negative attention from regulators. Avoiding lawsuits and negative attention from regulators is important to preserve brand reputation and also to ensure the company can attract investors to keep growing.

The distinction between CPG products goes beyond the label and is important because each category implicates different regulatory requirements. Using appropriate promotional language can not only convey the right information to consumers, but also regulators.

What makes a food a food?

The U.S. Food and Drug Administration (“FDA”) considers food to be “articles used for food or drink for man or other animals” that provides “taste, aroma, and nutritive value.”  Dietary supplements are intended to supplement the diet and contain dietary ingredients such as vitamins, minerals, or herbs. Each has its own set of distinct requirements under FDA regulations. For example, manufacturing regulations differ. 

If a dietary supplement brand uses a copacker, as an “own brand distributor,” it is responsible for ensuring the copacker meets FDA’s requirements. Alternatively, if a food brand uses a copacker, the law does not impose the same heightened requirements.

But what about an energy drink, or a bar eaten once daily for a specific purpose? These products could easily reside in either the food or supplement world.

The intended use of a product (as perceived by consumers) as communicated in product labeling and advertising can be the difference between a food and a dietary supplement, or could lead a regulator to allege that a product that should be marketed as a food of supplement is instead a drug.

Marketers should tailor their advertising to avoid incorrectly promoting their product in the wrong category and, consequently, implicating regulatory requirements the company may not be prepared to meet.

Taste, aroma and nutritive Value

Food advertising should largely stick to claims about the product’s taste, aroma, or nutritive value, consistent with FDA’s position:


  • “Indulgent chocolate flavor”
  • “New and improved taste”
  • “Satisfying crunch”

Nutritive Value (note: claims that characterize nutrients, such as “high in” or “good source of,” have specific regulatory requirements):

  • “With 10 g of protein”
  • “A good source of fiber”
  • “Sugar free”

The Do’s and Don’ts of Supplements

Food and dietary supplement advertising overlap a lot, but certain factors signal that a product is marketed as a supplement:

  • Labeling: Supplements bear a “Supplement Facts” panel as opposed to the “Nutrition Facts” panel used for foods.
  • Recommended use: Foods are consumed for the reasons noted above and can be eaten as part of a meal or on their own. Supplements, as the name implies, are primarily used to supplement the diet, and often include usage directions such as “take one tablespoon twice per day.”
  • Composition: Foods typically contain mostly ingredients that are commonly considered to be foods. Supplements contain ingredients that are usually not consumed for taste or aroma on their own, such as botanical ingredients, vitamins, or amino acids.

Steer clear of these claims

Of course, the lines between food and supplements can be blurry. Many of us consume coffee not only because we like the taste, but also for that extra pep we might need in the morning. Along these same lines, energy drinks can be marketed as foods or supplements. Assess the overall impression conveyed by the product advertising to determine if a consumer is likely to consume the product for its taste, aroma, or nutritive value, or primarily for its functional effects or to supplement the diet. Importantly, the ingredients that can legally be used in a dietary supplement and a food may differ.  That is, an additive may be acceptable as a dietary ingredient, but unlawful if added to a food. 

For both categories, advertisers should steer clear of making claims suggesting a product can mitigate, prevent, treat, or diagnose a disease. FDA considers these to be “disease claims” that are exclusively reserved for drugs, which carry far more stringent regulatory requirements than food or supplements. FDA commonly issues warning letters for products make disease claims and notes that advertisers are promoting unapproved drugs when they make such claims.

Common features of disease claims include:

  • Referencing a disease or symptoms of a disease, whether directly or indirectly: “product X has been studied for its ability to reduce inflammation”
  • Comparing the product to a drug: “people using product X don’t need their prescription medication anymore”
  • Suggesting that a product can have any effect on the disease condition: “lessen symptoms of arthritis”

The distinction between CPG products goes beyond the label, and exploring the right product classification early can help a CPG brand stay on the right footing – or even afloat.