A promotional claim for treatment of irritable bowel syndrome (IBS) was cited by FDA in a recent "courtesy" letter to Heather & Company IBS regarding Heather's Tummy Fibers Organic Acacia .

The agency took issue with IBS-related statements on the product's label in its Aug. 31 letter, including a claim that the product "relieves pain, diarrhea, constipation and bloating from irritable bowel syndrome." FDA also cited a referral to a company ¹ website and a statement reading "products for irritable bowel syndrome."

The agency says the IBS claims indicate the product is "intended to treat, prevent or mitigate a disease," suggesting the product is intended for use as a drug.

A number of agency "courtesy" letters sent in August and September target supplements making disease claims (see chart).

In a Sept. 29 letter, statements for ZEO Health's Esdifan such as "stops diarrhea," "relieves diarrhea" and "prevents diarrhea" suggest the treatment, prevention or mitigation of disease, FDA says.

Dragon Herbs' supplement Pearl was the subject of a similar letter for claims stating the product is "beneficial for habitual constipation" and "can help lower blood pressure."

The company's Duanwood Reishi was cited for the statements "help the body respond to microbial invaders such as viruses, bacteria and yeast" and "helps lower HDL [sic] (the "bad" cholesterol)."

FDA maintained the claims suggest the products are intended to treat "hypercholesterolemia, hypertension, chronic constipation and infectious diseases."

Several other products have been targeted for blood sugar or blood pressure-related statements deemed disease claims by FDA, including Leiner Health Products' YourLife Evening Primrose Oil.

Leiner said the product "may regulate the nervous system and influence many critical body functions such as the reproductive cycle, blood pressure and blood clotting." FDA pointed out the claim does not specify it is for blood pressure "already within normal limits," and therefore is a disease claim.

Leiner says the claim was inadvertent and was modified on Sept. 30 to reflect that the product is for blood pressure already within the normal range.

Heather’s Tummy Fibers IBS Claims Draw FDA Courtesy Letter

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