Are artificial dyes in your meds harmful-or misunderstood? In this episode of Rumor vs Truth, TRC Healthcare experts explore the science behind medication and food dyes, recent FDA changes, and how pill color may impact patient perception. Patrick Lupinetti questions why artificial colorants are added to drugs when consumers have concerns about artificial ingredients in foods. Colouring agents or colourants or colour additives (British spelling) or Coloring agents or colorants or color additives (American spelling) are excipients used in a formulation to enhance patient compliance.
According to USFDA, A color additive or coloring agent is defined as any pigment, dye, or other substance that can impart color to a drug, food, or cosmetic, or to the human body. FDA Regulation of Color Additives in Drug Products Bhakti Petigara Harp, Ph.D. Office of Cosmetics and Colors Center for Food Safety and Applied Nutrition Food and Drug Administration.
If you are sensitive to some of the "approved" Food Dyes & Colors you might have a hard time finding both over-the-counter (OTC) and prescription meds that are dye-free. When my kids had strep throat earlier this year, we were forced to accept the red food dyes that made the Keflex liquid pink along with the necessary antibiotics. FDA banned the use of Red Dye 3 in food and medications.
Here's what drugs contain Red Dye 3 and how the ban affects OTC and prescription medications. The use of food coloring is permitted in medicines, without any risk assessment related to vulnerabilities and pathologies. If you are wondering what pharmaceutical colors are and why colors or coloring agents are added to medicines, this blog.
What are coloring agents? Many industries use colorants, including food & beverage, pharmaceuticals, paint and clothing, plastics, photographs, prints, ceramics, and more. Certified dyes can be used in food products for humans and animals, for cosmetic products, and in prescription drugs and over-the-counter medications (OTCs). The amounts of dye used in commercial products is proprietary and not disclosed on the product label.
Facts on the safety of color additives - dyes, or substances that can impart color when added or applied to a food, drug, cosmetic, or the human body.