KOSHER MEDICATION YEAR ROUND AND PESACH:

Does Over the Counter Need to be Under Hashgacha?

Rabbi Dovid Heber - Kashrus Administrator Star K

©1995 Kashrus Kurrents, Vol. XV, No. 3, Summer, 1995; Reprinted with permission.
(adapted for the internet, Hebrew in the original is transliterated and or translated.)

It comes as no surprise that throughout the year, one of the most common questions asked on the Star-K Kashrus Hotline relates to the Kosher status of medicines, vitamins, and various cough and cold remedies. Most "standard" food inquires have standard answers. If the question is "Do cookies require a hechsher?", the answer is a simple yes. When one asks, "Does club soda require a certification?", the answer is no.

Kosher medication inquiries do not have such simple answers. When one looks into components of medicine and vitamins one discovers that they may, indeed, contain non-Kosher ingredients. Yet, the Star-K cannot simply say "medicines require a kosher certification" for two important reasons. First, Halacha (Jewish Law) often makes allowances for one who is ill. Hence, in certain instances one may be permitted to take a possibly non-Kosher medicine. Second, because many medications have a very unpleasant taste and are not fit for normal consumption, they may be permissible regardless of their non-Kosher content. Let us examine the facts to see how Halacha deals with these important Kashrus issues. Please note that in matters of Halacha one should follow the posek of one's own Rav or Posek. The following guidelines are based on the posek of Rav Heinemann, shlita.

DETERMINING THE ILLNESS

There are three categories of one who is ill:

I. חולה שיש בו סכנהCholeh sheyesh bo sakanah, Someone who is ill and whose life may be in danger may use any non-Kosher medication, if an equally effective Kosher medicine is not readily available. Included in this category is someone whose life is currently not in danger, but if untreated could develop a life threatening complication such as an elderly person who has the flu, or a newborn infant with a fever. Also, one who was prescribed antibiotics or other medication by a doctor for an infection or serious condition should take them, even though the Kosher status of the medication cannot be determined. All instructions given by the doctor should be carefully followed, including taking the medication for the prescribed number of days, even though the symptoms may have subsided. This applies even to medication that is flavored and tastes good. All of the above is equally applicable on Pesach to medication which contains חמץhametz..

II. חילה שאין בו סכנהCholeh she'ain bo sakanah, Someone whose life is not in danger. This includes anyone who is bedridden, is noticeably not functioning up to par due to pain or illness, or has a fever which is not potentially life threatening. A child under six years of age who has discomfort is also considered a חולה שאין כו סכנהCholeh she'ain bo sakanah. Someone whose life is not in danger. Such a person may take medication that is אינו ראוי לאכילת אדםAino reuii leachila adam. "Not fit for human consumption" or even שלא כדרך אכילהShe'lo ki'derech achila "in an uncommon manner."

III. One who has a מיחושmichush - Someone who is uncomfortable but is able to maintain routine activities despite his discomfort. This could include a minor headache, indigestion or discomfort from the common cold. Although such a person may take non-Kosher medication which is אינו ראוי לאכילת אדםAino reuii leachila adam "not fit for human consumption," it is questionable whether he may take it שלא כדרך אכילהShe'lo ki'derech achila "in an uncommon manner." Therefore, a Rav should be consulted. (ע' חכ"א בבינת אדם סי" נ"ב) (footnote in Hebrew version).

Medication is considered אינו ראוי לאכילת אדםAino reuii leachila adam. "not fit for human consumption" if all ingredients have no food, hydration, or nutritional value (e.g. charcoal tablets generally consisting of 100% activated charcoal). However, most tablets contain a substantial amount of starch which is a food. Food that has decomposed to an inedible state is also considered אינו ראוי לאכילתAino reuii leachila not fit for human consumption

Medication is considered שלא כדרך אכילהShe'lo ki'derech achila "in an uncommon manner if one of the following conditions are met:

1. Medication which is manufactured to be swallowed without chewing. When one swallows such a tablet, gelatin capsule, or caplet, he is doing so שלא כדרך אכילהShe'lo ki'derech achila "in an uncommon manner".
2. Poor tasting liquids (e.g. unflavored milk of magnesia) or tablets which are unflavored and unsweetened are considered שלא כדרך אכילהShe'lo ki'derech achila "in an uncommon manner". This is because under normal circumstances people do not consume such products.

As a general rule, any type of חולהCholeh(sick person), even one who has a מיחושmichush, may take medication that contains a non-Kosher ingredient which is בטל בששיםBa'tul bishishim (nullified to less than 1.6%). Although this is true with medication, when dealing with food, there may be additional variables to consider before being מטיר משום ביטולma'tir mishum bi'tul (acceptable because of being annuled). Currently, efforts are in progress to work with the packaging industry to ensure that even בטלbatul

SPECIFIC MEDICATION GUIDELINES

I. Cough Syrups, Liquid Decongestants, Expectorants

These products are generally taken כדרך אכילה ki‘derech achila (in the manner of eating) because they contain flavors which give them a good taste. The most problematic ingredient in these products is glycerine. This ingredient, which is not בטל כששים ba‘tul bi‘shshim (nullified as one sixtieth) in the elixir and if present would be listed as an inactive ingredient, is derived from animal, vegetable or petroleum sources. Unfortunately, it is very difficult to determine which source is used because glycerine is usually sold by distributors who will sell whatever type they have in stock. Furthermore, animal derived glycerine is generally cheaper than the other grades. The cough syrup manufacturers do not necessarily specify or adequately control which type of glycerine is used in their products. Therefore, one should preferably purchase cough syrup with a hechsher (such as Naldecon bearing an OU) or review the label to ensure that the product does not list glycerine. Although guaifenesin, an active ingredient in most cough syrups may be partially composed of glycerine, one need not be concerned, as this glycerine (not listed on the label) is בטל batul in the finished product.

What can one who has a מיחוש michush or even one who is a חולה שאין כו סכנה Choleh she‘ain bo sakanah. Someone whose life is not in danger do if he finds it necessary to take a good tasting cough syrup that contains glycerine that may not be Kosher? The solution is to mix each required teaspoon of elixir into 2 fl. oz of juice. The possibly non-Kosher glycerine would be בטל כששים ba‘tul bi‘shshim (nullified as one sixtieth).

The rationale for this is as follows: Under normal circumstances the rule of אין מבטלין איסור לכתחלה Ain mavatlin eesoor l‘chatchila applies - one may not add 60 times Kosher food to non-Kosher food to nullify it. For example, one cannot add pieces of bacon to a cholent sixty times larger than the bacon thereby being מבטל m‘vatel it. This only applies to חראי איסור vadai asoor food which is unquestionably not Kosher. however, one is permitted to be מבטל ספק איסור )ע' ש"ך יו"ד סי' צ"ב סק"ח( m‘vatel safek eesoor Therefore, since the cough syrup is only ספק איסור safek eesoor (the glycerine may be Kosher) one could be מבטל m‘vatel it לכטחלה l‘chatchila by adding it to a Kosher beverage. The Star-K discussed this with various companies who determined that cough syrup does not lose its potency by adding the prescribed amount to other beverages. These companies recommend mixing it with orange juice, apple juice, or water and drinking the entire solution. The reader is cautioned that these methods and percentages of ביטול bitul cannot be applied to other cases. (ע‘ רמ"א יו"ד ס' צ"ב ס"ד לא אמרין חנ"נ אם נחערב איסלר לח בהיתרלח וכו' בשאר איסורים לצורך הפסד גדול) If dilution presents a difficulty (e.g. for an infant) a Rav should be consulted.

II. Over the counter medications

whose Kashrus status needs to be addressed include the following: acetaminophen, antacids, aspirin, antihistamines, ibuprofen, laxatives, sleeping aids, and anti-diarrheal preparations.

Liquids Unlike cough syrups these remedies are less likely to contain problematic ingredients and may be taken even by someone who has a מיחוש michush . Even if they contain possibly non- Kosher ingredients such as glycerine, vegetable oil, alcohol or animal based emulsifiers (e.g. various simethicone emulsions), if the finished product tastes unpleasant it would be considered שלא כדרך אכילה She‘lo ki‘derech achila and may be taken by a חולה שאין כו סכנה Choleh she‘ain bo sakanah. (Someone whose life is not in danger). If the medication tastes good and the ingredients are only "questionable," even one who has a מיחוש michush could dilute the medication, as discussed previously.

Tablets- In tablets, ingredients of greatest Kashrus concern include magnesium stearate, calcium stearate and stearic acid. These inactive ingredients serve as lubricants which allow the medicinal powders to adequately "flow" through the processing equipment. The stearates also make it easier for the finished tablet to "release" from the punches and dies at the final compression stage where the tablet is formed. These "stearic" ingredients can come from either animal or vegetable derivatives. However, under normal circumstances enough lubrication will be provided with less than 1% stearates making them בטל כששים ba‘tul bi‘shshim (nullified as one sixtieth). And permissible. However, in some instances the product may contain stearates that are not batul~ (e.g. some Hydroxide based antacids) or other possibly non-Kosher ingredients (e.g. emulsifiers).

להלכה למעשה L‘halacha l‘ma‘aseh, even one who has a מיחוש michush - may take tablets חולה שאין כו סכנה Choleh she‘ain bo sakanah . if the only Kashrus concern is whether or not the stearates are batul (a ratio difficult for the consumer to determine). If the tablet is definitely non-Kosher, a חולה שאין כו סכנה Choleh she‘ain bo sakanah may take it שלא כדרך אכילה sh‘lo kiderech chila . However, one who has a מיחוש michush - and finds it necessary to take such non-Kosher medication, or a חולה שאין כו סכנהCholeh she‘ain bo sakanah who requires non-Kosher flavored chewable tablets (i.e. שלא כדרך אכילהShe‘lo ki‘derech achila should consult with their Rav. Gelatin Capsules - Gelatin is an ingredient that is derived from an animal. Currently all gelatin capsules on the market come from non-Kosher approved gelatin. Swallowing a capsule is considered שלא כדרך אכילה She‘lo ki‘derech achila and may be taken by a חולה שאין בו סכנה choleh sh‘ain bo sakanah. (A sick person who is not in danger.) One who has a מיחוש michush - should consult a Rav before taking gelatin capsules. Opening the capsule and removing the "Kosher" contents is not always advisable, as removing the gelatin capsule could cause the product to lose its intended effect. A pharmacist or doctor should be consulted to determine if this method is advisable.

III. Vitamins

Vitamins can contain various problematic ingredients and a full discussion of this is beyond the scope of this article. A person whose health problem has been attributed by a doctor to vitamin deficiencies, as well as pregnant and nursing women who have been advised to take vitamins, follow the same Kashrus guidelines for רפואה rifuah as a חולה שאין בו סכנה choleh sh‘ain bo sakanah. (A sick person who is not in danger.). Therefore, they may take non-Kosher vitamins שלא כדרך אכילה She‘lo ki‘derech achila if an equally effective Kosher vitamin is not readily available. One who is in good health and takes vitamins as supplements or for prevention purposes should preferably take vitamins only with a reliable hechsher. Currently the Star-K certifies various Shaklee vitamins. Freeda Vitamins are certified by the OU. Where such products are unavailable, one should ask his Rav or Kashrus agency about vitamin components of non-certified brands to determine whether the product can be taken.

MEDICATIONS ON PESACH

Determining the Pesach status of medications for Pesach is obviously more complicated than the rest of the year. Every year Rabbi Gershon Bess Shlita researches thousands of medications for a Pesach guide published by the Kollel of Los Angeles. It is important to note that this and other such lists consider the chometz issues, not the Kashrus considerations presented above. The Pesach guidelines are as follows: the source of the active ingredients may not come from chometz derivatives such as rye or wheat. Flavors also require research.

In addition, liquid medications containing grain alcohol derived from wheat should be considered chometz. In most instances, something containing chometz may not be used even externally and should be sold with the chometz. "Grain alcohol" is also commonly derived from kitniyot such as corn. Corn syrup is also commonly used in liquid medications. Because a חולה שאין בו סכנה choleh sh‘ain bo sakanah. (A sick person who is not in danger.) may take kitniot based medications, they are usually listed on the approved for Pesach list. In addition, kitniot based shampoos and cosmetics are also included in this list because they are not taken internally.

Tablet medications are chometz if they contain wheat starch, wheat gluten, malt extract, or other powders which consist of chometz (e.g. rye or barley). If such a medication is required, a Rav should be consulted. Kitniot powders such as corn starch follow the same guidelines as corn syrup mentioned above. All insulins may be used on Pesach. All high blood pressure, heart, diabetic and seizure medication in any form may also be used on Pesach.

In general, for updated information regarding the Kosher status and Kosher for Passover status of specific over the counter tablets and liquids call the Star-K Kashrus Hotline at (410)484-4110.

As important as one treats the laws of Kashrus, one is also obligated to treat the mitzva of ונשמרתם מאד לנגשתיכם nishmartem m‘od l‘nafshotaichem "Take care of your health". Therefore, under no circumstances should an individual forego taking a prescribed medication during the year or on Pesach without first consulting one‘s physician and Rav for a careful analysis of the situation. May we merit that, HaKadosh Boruch Hu grants us good health and that such שאלות shealot do not arise.