Supplement or Conventional Food Category Discussion

When is a product that is labeled as a “dietary supplement” not a supplement?

The answer is “When it is represented as a conventional food,” along with a few other factors I mention below.

In this warning letter, the company was cited for labeling a chocolate bar as a supplement. The question “Is this a supplement or conventional food?” often arises in my consulting practice, and here are some general parameters to help companies decide.

• Are the product ingredients only permitted in supplements? = dietary supplement
• Is the product represented as a sole item of a meal (e.g., a meal replacement)? = conventional food
• Is the product represented as conventional food (e.g., “supplement” soup)? = conventional food
• Is the product intended to be ingested? = supplement or food
• Is the product subject to drug trials or approvals? = not a supplement

From warning letter: “Your use of “Dietary Supplement” as a statement of identity and a “Supplement Facts” panel for nutrition labeling does not make your product a dietary supplement because your Amanita Muscaria Magic Chocolate product is represented for use as a conventional food. Examples of factors and information that establish that the product is represented as a conventional food follow: Chocolate Bar: The use of a combination of ingredients characteristic to a chocolate bar which are listed on the website (including chocolate, sugar, cocoa butter, soy lecithin, natural vanilla flavor, and milk); and The appearance and packaging of the product as a chocolate bar.”

From warning letter: “(The) product is represented for use as a conventional food, for example, by the use of the word “Chocolate” in the statement of identity on the package label.”

The main issue is likely that Amanita muscaria is not GRAS for foods. It can be dangerous, especially if a child eats an entire bar of Amanita chocolate.

I ran Apex Compliance® on the company’s website and found some wild claims related to insomnia and anxiety. I am surprised these are not mentioned in the warning letter.

In addition to the chocolate bar, other products that are common forms of supplements are mentioned (capsules and tinctures). The amanita capsule and tincture “supplements” were cited for being unsubmitted New Dietary Ingredients. My reading of this suggests that perhaps there may be a pathway for amanita to be sold as a dietary supplement IF it goes through the NDI safety and submission pathway. This is a big if, but, I guess it may be possible.

This is an interesting waning letter and worth a read.