Many companies are beginning to take advantage of the huge public demand for specialty/gourmet mushroom supplements. They are beginning to grow mushrooms and powder, dry, and extract them for compounds that they are marketing as dietary supplements, such as mushroom coffee.

In the United States, dietary supplements are regulated as foods, not drugs. Therefore, pre-market evaluation and approval of such supplements by the U.S. Food and Drug Administration (FDA) are not required unless specific disease prevention or treatment claims are made.

Because dietary supplements are not formally reviewed for manufacturing consistency, ingredients may vary considerably from lot to lot and there is no guarantee that ingredients claimed on product labels are present (or are present in the specified amounts).

The FDA has not approved the use of medicinal mushrooms as a treatment for cancer or any other medical condition

Though not legally applicable in Illinois, Cornell Tincture Law provides these potentially legally relevant guidelines:

• 27 CFR § 31.64 - Apothecaries or druggists selling medicines and tinctures
• § 31.64 Apothecaries or druggists selling medicines and tinctures.
  Apothecaries and druggists who use wines or spirituous liquors for compounding medicines and in making tinctures that are unfit for use for beverage purposes are not considered to be dealers by reason of the sale of those compounds or tinctures for nonbeverage purposes. (26 U.S.C. 5002)

What does all this mean for Illinois creators of specialty mushroom extracts and other mushroom supplement products?
All specialty mushroom extracts, tinctures, or other types of mushroom supplement products must have a label with some variant of the typical supplement FDA disclaimer, which generically reads: “This product is not intended to treat, cure, or prevent any disease, condition, or ailment. This product has not been evaluated by the FDA."

If mushroom businesses make no medicinal or health claims (i.e. this product will treat, cure or prevent something, they will be left alone and should have no problem selling. {Illinois Environmental Health Association)

For more information on dietary supplements check the FDA website.