Table 3 Perceived issues resulting from the absence of a clear definition and classification for HMs, with participants’ quotes extracted from transcripts of interviews with officials at the Kuwaiti drug regulatory authority

Confusion on how to carry out the regulatory process

“We are not sure that some products should be classified in the unclassified unit. So you see here there is a confusion. Reviewers are confused to where best classify the product because there is no clear guideline to follow. Sometime I am lost” (KI13)

Difficulties in deciding where to register products that include a mixture of herbs and other ingredients

“We receive products that contain many herbs and many vitamins, it is hard to make a conclusion whether this product is a herbal product or a vitamin product. What is happening that we are puzzled. How should we classify herbal products with vitamins? According to what? Is it according to the number of herbs? What if we receive a product that has a number of herbs are equal to the number of vitamins? And what about the pure herbs? “(K12)

Participants feel that agents have more power

“…the sad thing that the power of agents and companies exceeds our power. We are the supervisory authority, we should have the power” (KI17)

Restrictions as a result of the term herbal medicine

“The terms are restricting us. We do not have something called herbal supplement. When the agent hears the name medicine, they are frightened because this means stricter registration process so they go to the unclassified unit to register this herbal supplement” (KI22)

Inappropriate pricing system

“I do not get the concept of regulators in not forcing all products to be priced. From their point of view, they claim that dietary supplements are not a mandate; you do not take it to increase your life expectancy or to treat or cure a disease you have… people are taking them as a luxury. But if this is the case, then why do you price products in the herbal department? Not all of them are medicinal and not all of them have a medicinal use. My opinion everything must be priced” (KI16)

The lenient regulatory process in the Unclassified Department

“As a Herbal Department, we should have all herbal products that have purely herbal active ingredients registered here. The unclassified unit is here to provide a gap for agents instead of waiting a long time for their products to be registered at the herbal unit…” (KI10)

Inconsistency and duplication in registration of many HMs with the same active ingredients and characteristics

“What happens now is that the agent submits the product to the Unclassified Department while the product must be registered in the Food Department. And you find another agent, submits this exact active ingredient of a product in the food supplement and they both get registered but in different departments. But tell me, which one is the right department? How could we know for sure if we do not have clear regulation or information indicating what circumstances makes an herbal product a herbal medicine, food supplement or dietary supplement or even a vitamin” (KI16)