Nothing to Sneeze At

July 20, 2004

In an important breakthrough for kosher consumers, the Orthodox Union (OU) and Novartis Consumer Health, Inc., a NJ-based Novartis company, jointly announced today that the company’s Triaminic® brand pediatric cold/cough/allergy liquid medications have been certified as kosher by the OU. Novartis Consumer Health, Inc. is the first major over-the-counter company to attain OU certification for pediatric cold/cough/allergy medications.

OU has certified eight varieties of Triaminic liquid. The products will be available in packages bearing the famed OU Kosher symbol this summer. They have been certified as OU pareve, meaning they contain neither meat nor dairy ingredients.

The eight varieties of Triaminic liquid are: Cold & Cough, cherry; Cough, berry; Chest & Nasal Congestion, tropical; Cough & Nasal Congestion, orange-strawberry; Flu, Cough & Fever, bubble gum; Cold & Allergy, orange; Night Time Cough & Cold, grape; and Cough & Sore Throat, grape.

The Orthodox Union is the world’s largest kosher certification agency, certifying over 275,000 products produced in nearly 6,000 plants located in 68 countries around the world.

“This is a very significant development for the kosher world,” declared Rabbi Menachem Genack, Rabbinic Administrator of the OU Kosher Division. “In addition to the enormous growth of food products being certified as OU Kosher, now a major line of over-the-counter pharmaceuticals is also being made available to the kosher consumer. Triaminic is respected as an effective cold/cough/allergy medication for children, but because of the presence of possibly non-kosher glycerin, among other products, kosher observant parents could not give Triaminic to their children. Now, thanks to the Novartis Consumer Health, Inc. – OU collaboration, they can.”

“The kosher marketplace has expanded to such a degree that manufacturers welcome the opportunity to receive OU certification and are willing to make the investment necessary to meet the OU’s demanding standards,” Rabbi Genack declared.

“Novartis Consumer Health, Inc. recognizes the importance of becoming a part of the ever-expanding kosher marketplace, and is proud to offer consumers a Triaminic product that meets the certified kosher standards of the Orthodox Union,” said Lynne Millheiser, Senior Vice President, OTC Business Unit North America.

The issue of whether medications must be kosher is often misunderstood, declared Rabbi Dr. Eliyahu Safran, Senior Rabbinic Coordinator at OU Kosher, who served as liaison to Triaminic executives and oversaw the product’s OU certification process. The issue, in fact, is so complex, that last year the OU sponsored a seminar for rabbis and other interested observers on kosher law regarding medications and vitamins.

“The guiding principle of Jewish law, as given to us in the Torah, is V’Chai Bahem – And you should live by them,” declared Rabbi Safran. “The Talmud explains that God gave us these laws for us to live by, so that our life may be enhanced and strengthened. However, these laws are put aside in order to maintain and continue life. Therefore, someone who is very sick on the Sabbath may call the doctor or drive to an emergency room. Someone who is very sick on Yom Kippur may eat. Not only can we do these things, we must do these things to preserve life,” Rabbi Safran explained. He added, “The Talmud says you can violate one Sabbath in most instances so that you will be able to observe the next 51 Sabbaths in the year.”

As a result of this philosophy, “Any medicine which is required for an illness which is even remotely life-threatening is not required to be kosher. Jewish law regarding solid tablets and pills is even less stringent, as they are inedible and swallowing them isn’t even considered like eating food.”

But over-the-counter medications, like cold/cough/allergy medications, are another story.

“People wrongly think these products don’t have to be certified. But they are taken in non-life threatening situations and therefore they must be certified,” Rabbi Safran said.

“For the enhancement of one’s health and the treatment of certain conditions that are not life-threatening, one must seek out a kosher product. One such example is cough syrup,” he declared.

Rabbi Safran noted that in addition to glycerin, cold/cough/allergy medications may contain many ingredients – including artificial flavorings – that may not be kosher. Moreover, the product could be a liquid that is ingested, much like food, and should be treated as food. Flavorings can give the product a pleasant taste, making it even more like food.

Triaminic breezed through the certification process, as complicated as it was, despite the large number of ingredients found in cold/cough/allergy medications. “As an OTC products company, Novartis Consumer Health, Inc. is accustomed to following the stringent requirements of the U.S. Food and Drug Administration to have products approved. As a result, it was very easy for them to follow the OU’s stringent requirements for certification,” Rabbi Safran explained.

Rabbi Safran worked closely – literally on a day-to-day basis – with Jila Breeze, Global Head of Quality & Compliance for Novartis Consumer Health’s Over-the-Counter Business Unit, based in Parsippany, New Jersey; and with Allison Johnson, Team Leader of Quality Assurance Documentation, based in the Lincoln, Nebraska plant where the cold/cough/allergy liquids are manufactured.

Both Ms. Breeze and Ms. Johnson maintained a close working relationship with the Rabbi, going over details and peppering him with questions. Ms. Johnson was in charge of producing the letters of certification for the multiplicity of ingredients that go into the various medications, a process that took several months. “There was a lot of documentation,” she said with a laugh, adding, “Rabbi Safran was very patient with us.”

Ms. Breeze was involved in the discussions with Novartis Consumer Health Management that led to the decision to seek kosher certification and to pursue the matter with the OU. Given the company’s experience with the FDA, “we were very prepared,” Ms. Breeze declared. “We had good documentation and good practices already in place.” When ingredients had to be changed, she said, they were.

“Novartis Consumer Health, Inc. identified with the kosher consumer market and decided that among its many products, it would begin the kosher process with Triaminic,” Rabbi Safran declared, adding that the process of certifying Maalox®, another Novartis Consumer Health, Inc. brand, is already underway.

When Novartis Consumer Health, Inc. executives were visiting OU headquarters to discuss the certification process, Rabbi Safran told them, “When a religious person is physically weakened, that person doesn’t want to be spiritually weakened as well. By adhering to the laws of kosher, a person – a child in the case of Triaminic – maintains his or her spiritual strength and integrity while the body is healing. That is why what Novartis Consumer Health, Inc. has done is so important.”