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Over the Counter Medicine

Rabbi Dovid Cohen
Administrative Rabbinical Coordinator of the cRc

March 2008

 

The term “over the counter medication” (OTC) covers a whole gamut of pharmaceutical products used to help people overcome all sorts of maladies or discomforts.  Many of these items contain kosher-sensitive ingredients, and conscientious consumers regularly ask which of these items may be consumed.  In short, the answer depends on four factors:

    A. Does the OTC medicine contain any kosher-sensitive ingredients?
    B. Can the questionable OTC medicine be replaced with a kosher substitute?
    C. How edible is the OTC medicine?
    D. How sick is the person taking the OTC medicine?

We will first discuss these four factors and then summarize with practical applications.  This document will not discuss the permissibility of medicines for Pesach.

A.  Ingredients in OTC Medicine

The active ingredients in most medicines do not pose a kashrus concern, and the same can be said of most of the inactive ingredients as well.  Some of the common kosher-sensitive ingredients found in medicines are:

  • Aspartame
  • Citrates (e.g. citric acid, sodium citrate)
  • Ethyl Alcohol 
  • Flavor (including natural flavor)
  • Gelatin
  • Glycerin
  • Gum Arabic (or acacia gum)
  • Lactose
  • Polysorbates (e.g. polysorbate 80)
  • Stearates (e.g. stearic acid, magnesium stearate)
  • Xanthan Gum
The above list of kosher-sensitive ingredients is not complete and is just a list of some common kosher-sensitive ingredients found in medicines.  Of these ingredients, there is no question that the one which raises the most serious kashrus concern is glycerin.  Of the other ingredients, some raise more of a concern than others; the explanation for why that is true and a brief description of the concerns with each of these ingredients can be found in the footnote.1

If a Rabbi working with an expert in food ingredient technology is able to determine that the medicine does not contain any kosher-sensitive ingredients and/or that any kosher-sensitive ingredients are batel, the medicine is of course permitted for consumption.  Thus, one step in determining the acceptability of a given OTC medicine is to make the above determination (or to look for an acceptable kosher certification symbol!). 

B.  Substitutions

Although we will see that there are cases in which one is permitted to consume a specific non-kosher medication that is only true if there is no reasonable kosher substitute available.  In this context, the term “reasonable substitute” depends on many factors which must be weighed by a doctor and Rabbi to determine whether the kosher alternative is in fact a “reasonable substitute”.  If it is, the kosher alternative should be used instead of the medicine which is of questionable kosher status.

Rounded Rectangle: Having determined that (A) a given medicine is non-kosher or contains kosher-sensitive ingredients, and that (B) there is no reasonable kosher alternative, we now proceed to the two questions which help determine whether the person may nonetheless consume the medicine, (C) edibility of the medicine and (D) severity of the sickness.

C.  Edibility of the OTC Medicine

As relates to our discussion, medicines can be grouped into 3 categories – edible, sheloh k’derech, and inedible – as follows:

-Edible  
Rav Schwartz defines “edible” as any food-like item which people derive some enjoyment from as they eat/swallow it. 

Examples:       Chewable pills, cough drop, glucose drink, liquid medicine (e.g. cough syrup)2 

-Sheloh k’derech
One who consumes an edible food item in an atypical manner which causes him to have little or no pleasure, is mid’oraisah not considered to have eaten the food, both as relates to fulfilling mitzvos (e.g. matzah) or violating prohibitions (e.g. non-kosher food, eating on Yom Kippur).  However, Chazal forbade the consumption of forbidden foods in this manner.  For example, one who swallows a piece of non-kosher meat which is wrapped in paper, or drinks vinegar or oil as is (i.e. not mixed into any other food) has (only) violated an issur d’rabannan.3 

Examples:       Gelatin capsule (soft or hard)4 

-Inedible
There is no prohibition against eating a medicine which is in an inedible form.5  In this context, Rav Schwartz clarified that (a) if one adds flavoring to an inedible item so as to help people consume it, the item retains its status as inedible, but (b) the same would not be true of, for example, a cough syrup which contains 5% inedible ingredients, 0.5% flavor and 94.5% edible ingredients.

Examples:       Pills and tablets (not chewable) 

D.  Severity of Sickness

Intuitively we understand that the halacha gives an infant suffering from dehydration due to diarrhea much more latitude in consuming a non-kosher rehydration formula than it does to a healthy teenager who is looking for a cold drink after a good game of basketball.  Although both require proper hydration to reinvigorate them, the infant’s life is in danger and he therefore has considerably more leeway.  In fact, the halacha recognizes three different levels of cholim (sick people):

-Danger (sakanah)
If there is even the smallest possibility that someone’s life might be in danger, one may violate (just about) any d’oraisah or d’rabannan prohibition if that will help the condition6 and there is no other reasonable alternative.  In many cases, people who suffer from an infection which can only be cured via a prescription medication, qualify as being in sakanah.

-Incapacitated (choleh she’ain bo sakanah)
A person who is in extreme pain or ill to the point that they are unable to function in a normal manner as relates to sleeping (i.e. they are unable to stay awake, or cannot fall asleep) or other normal functions (e.g. walking, eating), is permitted to violate most issurim d’rabannan including the consumption of food sheloh k’derech.7 8  One notable exception is that such a person may not consume foods which are forbidden mid’rabannan (other than sheloh k’derech).9  [Young children who are ill are assumed to have the status of being “incapacitated” even if a similar illness would merely qualify as a “discomfort” for an adult.]10

-Uncomfortable
People with minor illnesses or discomfort (e.g. common headache, cold, or toothache) or who are looking to improve their general hygiene or appearance (such as with mouthwash or toothpaste), are not permitted to violate any halachos – d’oraisah or d’rabannan – or minhagim.11 

In the example cited above, if there is any question that the dehydrated infant’s life may be in danger, he may consume a non-kosher rehydration beverage if a kosher alternative is not available.12  On the other hand, the healthy teenager is in no danger and will not even be incapacitated if he does not find a drink, and therefore he must find a kosher beverage to make him more comfortable.


Practical Applications

Chewable pills............. See Sappirim 14 for a discussion on whether chewable pills and liquid medicines are considered edible.  For purposes of this document we will assume that chewable pills and liquid medicines are considered edible and should only be consumed if they contain no kosher-sensitive ingredients (which are not batel), bear kosher certification, or are being taken for someone who is classified as being in a state of sakanah.  However, Rav Schwartz has ruled that if there is a question whether a given liquid or chewable is edible and a doctor has recommended it to treat or prevent a serious condition, one should err on the side of assuming the medicine is not edible and consume it even if its kosher status is unknown.

Flavors........................ There is a chance that the flavors used to improve the taste of liquid or chewable medicines may contain non-kosher ingredients, and therefore any uncertified item which contain “flavors” (natural or artificial) should be considered as possibly non-kosher and should not be consumed by those suffering from discomfort.  However, these flavors do not raise a concern when medicines are consumed by a person whose illness renders them incapacitated or in a state of sakanah.13

Gelatin capsules........... Medicine in soft or hard gelatin capsules may be consumed to treat an illness which renders the person incapacitated or in sakanah, assuming the person cannot reasonably find or use an alternate medicine which is not gelatin coated.  OTC medicine used to relieve relatively minor discomfort may not be consumed if they are in gelatin coated.14

Liquid medicines.......... See chewable pills above.

Tablets/pills................. Non-chewable tablets/pills are not edible and may be swallowed or otherwise consumed regardless of whether the ingredients are known to be kosher.

Vitamins...................... The status of vitamins will IY”H be discussed in a separate document

 

 

1 In weighing how serious the kashrus concern of a given ingredient is, the following factors must be considered: (a) how likely it is that the ingredient is non-kosher, (b) whether the ingredient is used in amounts which are batel b’shishim, (c) whether the ingredient is it not batel due to other factors (avidah lit’amah, davar hama’amid) and which of those factors may be waived for a given choleh, (d) what is the status of flavors of unknown kosher status, (e) whether one should be concerned that the ingredient is possibly inherently non-kosher or whether the most serious concern is that it was produced on non-kosher equipment (in which case it may qualify as מלח הבלוע מדם ), (f) whether the potential non-kosher ingredient is an issur d’oraisah or issur d’rabannan.
        Of the ingredients listed, glycerin is clearly the most kosher-sensitive because (a) about half of the glycerin in the world market is made from animal fat (i.e. issur d’oraisah), and a sizeable portion of the vegetable-based glycerin is processed hot on the same equipment as animal-based glycerin (without cleaning), and (b) glycerin is commonly used in high proportions (approximately 20-30%) and has a characteristic sweet taste, such that it is not batel or pagum.
        Stearates and some polysorbates (60 and 80) may contain animal products, and (uncertified) gelatin is typically produced from pig skins, but these items are typically batel b’shishim in the medicine (although the polysorbate and gelatin may be considered a ma’amid; i.e. not batel mid’rabannan).  [Gelatin capsules will be discussed below in the text.] 
        The raw materials used in producing lactose and ethyl alcohol might be assur mid’rabannan (stam yayin, meimei chalav, gevinas akum; and lactose is similarly only dairy mid’rabannan). 
        Polysorbate 20 and gum Arabic are typically (a) made from kosher raw materials and (b) used in tiny proportions which would be batel b’shishim (although they may be considered a ma’amid; i.e. not batel mid’rabannan), but these ingredients and/or their sub-ingredients are sometimes produced on equipment which is also used for non-kosher products.  Aspartame, citrates, and xanthan gum are made through fermentations which typically do not pose a kashrus concern, but are nonetheless assumed to require hashgachah as fermentations are sophisticated processes which occasionally use non-kosher ingredients.  [Xanthan gum is different than other gums in that it is typically used in proportions which are not batel b’shishim].
        Flavors will be discussed below in the text and in footnote 13**.

2 The edibility status of liquid and chewable medicines will be discussed in more detail in the text below.

3 Eating meat wrapped in paper (based on Pesachim 115b, כרכן בסיב ), drinking vinegar, or eating black pepper as is (Yoma 81b, and see there in Rashi s.v. kas pilpilin), or drinking oil as is (Berachos 35b).  Noda B’yehudah (YD I:35, cited in Pischei Teshuvah YD 155:6) infers from other words in Gemara, Pesachim ibid. (בלע מצה יצא ) that swallowing an edible food item such as matzah is not considered sheloh k’derech, because swallowing is merely considered another method of “eating”.  Thus, since chewed matzah is eaten as is, one who swallows un-chewed matzah at the Seder has also has also fulfilled a mitzvah.  However, since no one consumes vinegar, black pepper, or oil as is, it is considered sheloh k’derech to eat, drink or swallow them without first mixing them into other foods.

4 Gelatin is a food item which is used in gelled desserts, marshmallows and other foods, and is therefore considered “edible”.  However, pure gelatin (as is commonly found in hard gelatin capsules) or gelatin mixed with glycerin, sorbitol and certain other food ingredient (as is commonly found in soft gelatin capsules) is never eaten as is.  Therefore, Rav Schwartz asserts that swallowing a gelatin capsule is considered consumption sheloh k’derech.  This position is based on the presentation of the gelatin (i.e. its being pure) and not because the capsule is swallowed.

5 If a forbidden food item becomes inedible the prohibitions against eating that food are lifted, but it is nonetheless assur mid’rabannan to eat it because of the principle of “ach’shvei” which interprets the person’s choice to eat the item as an indicator that he considers it edible (Shulchan Aruch 442:4 & 442:9-10 as per Mishnah Berurah 442:43).  However, it is generally accepted that ash’shvei does not apply to a inedible medicines because (a) consuming inedible medicines shows that one values them as a health remedy and not that one considers them edible, as evidenced by the fact that people eat awful tasting medicines (Iggeros Moshe OC II:92, Achiezer III:31:3-4 and others) and (b) logically, ach’shvei only applies to the medicinal portion of what one consumeds and not to the inactive ingredients (Chazon Ish OC 116:8).

6 If a person is a choleh sheyesh bo sakanah, he may violate issurim to alleviate the sakanah, but may he also do so for the parts of the treatment which have no bearing on the danger he is in?  Mishnah Berurah (Mishnah Berurah 328:14, Sha’ar HaTziun 328:11, and Biur Halacha s.v. kol) cites a machlokes regarding this issue, and notes that Shulchan Aruch 328:4 appears to accept the lenient opinion, but Mishnah Berurah recommends that one follow the strict opinion as relates to issurim d’oraisah.  However, he notes that even the strict opinion agrees that one may violate an issur for non-critical treatment (for a choleh sheyesh bo sakanah) if there is “great need”, if doing so will strengthen the patient, or if not providing the treatment might cause him to deteriorate.
        Accordingly, it would seem that a choleh sheyesh bo sakanah would be permitted to take a non-kosher OTC medication which provides comfort even if it does not treat his underlying sickness if (a) the ingredients are only assur mid’rabannan or would be batel if not for a d’rabannan principle (e.g. davar hama’amid) or (b) it helps the patient sleep or function (e.g. pain relief, decongestant, sleep aid) so that his body can recover or at least not deteriorate.  It is also noteworthy that Shulchan Aruch would permit all medications, and Yabeah Omer IV:30 defends that position.

7 Shulchan Aruch/Rema YD 155:3

8 Tzitz Eliezer (VI:16:3 and in the addendum) cites Poskim who hold that a choleh she’ain bo sakanah may consume a chatzi shiur of issur especially if the issur comprises less than 50% of the food, and Tzitz Eliezer appears to accept this position.  Although chatzi shiur is forbidden mid’oraisah, these Poskim hold that it is a “weaker” d’oraisah which is waived for a choleh she’ain bo sakanah.  This leniency has far reaching consequences because (a) the typical dose of OTC medicine is just a chatzi shiur and the issur is rarely more than 50% of the medicine and (b) many people who consume these medicines qualify as a choleh she’ain bo sakanah, and the (sick) young children who requires such medicines are always given that status (see Rema 328:17).

9 See footnote 7**.

10 See Rema 328:17.

11 However, see Mesorah 14 where Rabbi Heber cites Rav Heinemann as allowing one to consume a liquid medicine after diluting it in about 12 times its volume of a kosher liquid.  An example of this dilution would be mixing a teaspoon (5 ml) of Motrin into 2 ounces (59 ml) of water or apple juice.  He reasons that:

  • Medicines rarely contain more than 25% glycerin or other non-kosher ingredients, such that diluting the medicine in 12 times its volumes assures us that the non-kosher ingredients are batel b’shishim.  [The specific gravity of glycerin and water are 1.25 and 1 respectively, which means that if glycerin is 25% of the weight of the medicine (as a company would typically measure), it is only 20% of the volume (which is how bitul is calculated – Pischei Teshuvah Y.D. 98:2)].
  • The prohibition against consciously diluting issur so that it can be consumed (ain mevatelin issur l’chatchilah), is Rabbinic in nature, and therefore only applies to cases where the food is known to be forbidden but not to cases such as ours where it is only safek issur (see Shach 92:8 and elsewhere).  Similarly, the principle of ChaNaN (which would increase the amount required for bitul) does not apply to safek issur (see Gilyon Maharsha 98:34 to Shach 98:11). 

12 In fact, two kosher alternatives are readily available for most cases of dehydration, as follows:

  • Pedialyte is widely available in the United States and at the time of this writing, many (and possibly all) varieties of Pedialyte are certified kosher by the OU.
  • http://rehydrate.org/solutions/homemade.htm#recipes recommends the following easy to prepare rehydration formula for use when a professional variety is unavailable:  Mix one level teaspoon of salt, eight level teaspoons of sugar, and one liter of clean drinking (i.e. about 5 cupfuls), and stir the mixture until the salt and sugar dissolve.

13 The ruling in the text is based on a number of factors, including the following: 

  • Flavors typically comprise less than 1/60th of the volume of the medicine, such that many potential non-kosher components are either batel b’shishim or only not batel due to Rabbinic considerations (e.g. davar hama’amid) which are waived for a choleh she’ain bo sakanah.
  • The only components which are not batel mid’oraisah are those which are avidah lit’amah.  Almost all non-kosher avidah lit’amah ingredients are either (a) themselves only assur mid’rabannan (e.g. starter distillate) or (b) made from inherently kosher raw materials and only considered non-kosher as a result of being produced on non-kosher equipment.  The letter of the law is that the former are permitted (at least for cholim) based on safek d’rabannan l’kulah, and the latter are batel b’shishim based on the principle of מלח הבלוע מדם .
  • There are some avidah lit’amah flavor components which are inherently assur mid’oraisah (e.g. civet, castoreum), but they are typically reserved for sophisticated, expensive flavors used in food items and not used in pharmaceuticals.

Although it is always possible that the flavor in a given medicine is forbidden, Rav Schwartz holds that the factors noted above are sufficient to permit a choleh she’ain bo sakanah to consume the medicine.

14 The rationale for this ruling was given in footnote 4.

 

HaRav Gedalia Dov Schwartz, Shlit"a
Rosh Beth Din

HaRav Yona Reiss, Shlit"a
Av Beth Din

 

Rabbi Sholem Fishbane
Kashruth Administrator

Rabbi Levi Mostofsky
Executive Director

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