Kosher supervision demands that both ingredients and the production process are required to be kosher. The growth of the global ingredients supply chain for nutritional ingredients, and the many manufacturers pursuing kosher certification for those ingredients, has required OU Kosher to apply these principles of kosher law to a variety of production scenarios. Besides the active ingredients used in a health-fortified product, solvents, excipients, and other inactive substances are also required to be kosher. As a result, certification agencies are responding to a growing need for guidance on uncertified nutritional products.
What is Kosher and How it’s Applied to Kosher Certification
Informally, “kosher” refers to something proper or legitimate, but the word has a very specific and technical meaning. For food to be kosher, in the formal sense, the ingredients and the equipment involved in its production must conform to the detailed requirements of Jewish law, set forth in its fundamentals in the Bible and elaborated upon over time in the rabbinic scholarly tradition. This article will focus on how a certifying agency applies kosher law when certifying industrial food production, specifically with regards to ingredients commonly used in the production of functional foods, nutraceuticals, and dietary supplements.
There’s growing interest in kosher certification by manufacturers who are producing increasingly complex ingredients for the nutraceutical products.
This article will begin with three case studies: the certification of Vitamin D3 (cholecalciferol) from Peruvian fish oil, an ashwagandha botanical extract from India, and organic kale chips from Mexico. These cases have been selected because they draw on central principles in kosher law, show how those principles are interpreted and applied in specific industrial contexts, and demonstrate how a certification agency must adapt to the increasingly far-reaching supply chain needed to support the nutraceutical ingredients market. I’ll continue with a summary of the kosher status of key ingredients in nutritional products, specifically focusing on extract solvents, diluents, excipients and other inactive substances used in the delivery systems of nutritional ingredients. The concluding section discusses ways in which kosher certification agencies respond to consumer questions regarding the permissibility of consuming food products designed and promoted to boost health that are not kosher certified.
Vitamin D3 from Peruvian Fish Oil
A European manufacturer of nutritional ingredients operates a production line that converts 7-dehydrocholesterol to vitamin D3, or cholecalciferol (Vitamin D is used to prevent rickets, and is used to fortify both food and animal feed). In this particular process 7-dehydrocholesterol is produced from cholesterol that is isolated, in turn, from fish oil. The fish oil – and hence the 7-dehydrocholesterol — is not kosher certified. The manufacturer must now look for kosher certification. Their interest is motivated only in part by the fact that a kosher-certified vitamin D3 will give the product a broader marketing reach. A more pressing reason for seeking approval is practical: the same production line is also used, intermittently, to process several kosher certified products. After a non-kosher production run, the equipment must be dismantled and subjected to a kosherization process (cleaning and purging the equipment of its non-kosher status). Analogous to a quality assurance clean-out, the purpose of the kosherization process is to remove whatever traces of product that may have been religiously absorbed into the processing equipment during a previous production. The procedure uses not only energy – a considerable amount of hot water is needed – but also, more critically, time. Whatever hours are devoted to kosherization are lost for vitamin production, and the situation has become barely tolerable. The company has therefore asked its supervising agency to evaluate the viability of certifying vitamin D3.
There was an encouraging starting point: the fish oil in question was anchovy. Anchovies have fins and scales, and thereby conform to the Bible’s criterion for a kosher fish species. The quality and depth of a certification agency, however, lies in its ability to verify. Authenticating that “anchovy oil” refers only to that, and there is no trace of any non-kosher fish (or that the fish oil sample is not a wholesale misrepresentation) would present a unique challenge.
The anchovies were caught off the coasts of Peru and are further processed by a Peruvian fishmeal producer. The agency would need to dispatch a representative familiar with fish harvesting and identification methodologies to review the practices of the Peruvian fisheries, specifically with regards to determining what the levels of bycatch would be – in this case the presence of krill, shrimp, or other non-kosher crustaceans — in the catch of anchovies.
This would only be step one. Step two would require supervision of the fish processing facility in Peru, where the fish oil is separated from the fishmeal. The production process requires a cook stage. The same operative principle requiring kosherization at the European nutritional ingredients company’s plant would be at play at the Peruvian fishmeal facility as well: the cooker used to process the non-kosher species of fish in previous production runs would require a kosherization procedure prior to the production of any kosher certified anchovy fish oil production. Any production would require on-site supervision to ensure only kosher fish are processed, and the product, unrefined anchovy oil, would need to be properly tagged and secured before being shipped off to its next (penultimate) destination, a North American specialty ingredient manufacturer of fish oil ingredients, where the cholesterol will be separated from the rest of the oil.
Fish oil, when ethylated, yields a group of fatty acid ethyl esters. These esters can be fractionated to obtain, among other products, docosahexaenoic acid, which belongs to the class of extremely popular nutraceutical products known as omega-three fatty acids. A byproduct of the ethylation process is cholesterol. Once again, certification of the cholesterol would require that the equipment used for the ethylation would be acceptable. In this case, the facility was already kosher certified and therefore no significant adjustments would need to be made.
The cholesterol would finally be shipped to the European processor, who carefully converts the cholesterol to 7-dehydrocholesterol through a series of chemical steps, which is in turn converted to vitamin D3.
The success of the entire project rested, however, on the kosher purity of the original anchovy oil. A sustained review by the agency’s representatives at the Peruvian site indicated the presence of bycatch, which was demonstrated to be on-going and consistently at unacceptable levels. Kosher law provides, under specific circumstances, a de minimis threshold for tolerance of a non-kosher element mixed into a kosher substance. When and whether to rely on this tolerance threshold is a policy matter and is used with discretion by rabbinic authorities and only in narrow circumstances. In this case, because the presence of bycatch could not be judged to be non-existent, the only possibility of accepting the fish oil would be to determine whether the presence of non-kosher bycatch would be consistently and verifiably below the de minimis levels accepted by kosher law. The reports indicated that the presence of non-acceptable bycatch consistently failed even the minimal threshold requirements provided by kosher law and the project was shelved, much to the frustration of the parties involved.
Ashwagandha Extract from India
Ashwagandha (Withania somnifera) is a plant that has been used in traditional Indian medicine for millennia. The owner of a U.S. dietary supplements importing and wholesale company, keen on creating interest here in the U.S. for the plant’s reputed healing powers, purchased a quantity of liquid ashwagandha extract from an Indian ashwagandha farm. One of the U.S. importer’s biggest clients, a retailer of dietary supplements, insists on the product becoming kosher certified. The importer, in turn, convinces the India company to seek kosher certification.
The facility in India applies for kosher certification to one of the global certifying agencies. The initial feasibility review, conducted by the agency’s India representative, indicates that the extract medium is milk. The presence of milk presents a significant concern for kosher certification. Kosher law prohibits the mixing of milk and meat. It is therefore crucial for kosher consumers to be alert to a product that contains dairy. On the retail level the status of kosher is typically represented by a discreet symbol somewhere on the product’s label. If the product is dairy, the letter “D” is used to denote the dairy status. The market interest in a dairy product is markedly less than that of a product that has a neutral, or “pareve” status – which is denoted simply by the standard symbol of the kosher agency (besides the restrictions in using kosher dairy product, the “D” denotation is also a red flag for those with a dairy allergen or intolerance).
A different complication, however, renders this consideration irrelevant. Milk is in principle kosher, but it must be obtained from a cow (or any other kosher species) and the supply must be verified as such, in conformance with a unique set of acceptability parameters that kosher law requires for milk. Applying those requirements to the relatively provincial and unregulated milk supply chain at this rural India facility proved to be unacceptable.
The applicant proposes a solution: it can use an alternative solvent, ethanol. These extracts would be pareve, and the label would be cleaner and less complicated. Kosher law accepts ethanol without much complication. Separate, dedicated equipment can be used for the extraction process using these “pareve” solvents. The solvent would also be indicated on the certificates of analysis.
The agency generates a contract with the Indian ashwagandha extraction firm, sets an annual fee, determines internally how frequently their representative should inspect the facility (generally the inspections are unannounced) and grants the company the right to use its kosher symbol on its pareve products. Because of the unusual circumstance of the parallel milk extraction, the agency creates a special clause in the contract prohibiting use of the symbol on any product other than those that are extracted using water and ethanol.
The agency’s representative in India is assigned a specific number of times to visit each year. Among his protocols are checking production records that the extraction equipment is used only with ethanol and that the symbol is being applied only to the non-dairy product. The local India representative routinely reports to his counterpart at the certification’s headquarters office in North America, and the certification program proceeds.
Kale Chips from Mexico
Fresh organic kale, a dark leafy green packed with vitamin K and lutein, is strictly prohibited in Biblical law. Although this statement is true, it is slightly misleading. Fresh organic kale is innocuous and kosher and, insofar as it is healthy and delicious, even meritorious to eat. But repeated inspections of fresh, organic kale invariably indicate the presence of aphids, a species of insect that, although miniscule, can nevertheless be discerned by the trained, searching eye without any assistance from a magnifying glass or microscope. Aphids are prohibited by Biblical law (kale that has not been subjected to pesticides is obviously more likely to contain aphids than kale that has been sprayed).
A high-end snack food company has a kosher certified line of chips that includes beet, carrot, and sweet potato chips. The company is now interested in adding to its product line organic kale chips. Is this is a viable candidate for certification?
The account executive at the kosher certifying agency’s headquarters, who is assigned to coordinate the program’s supervision program, requests a process flow chart that describes the production steps kale undergoes before emerging as an edible chip.
The leafy green is first triple-washed, a process intended to remove all foreign matter. It is then subjected to a protracted drying process at intensely elevated temperatures. The account executive requests samples of the kale prior to washing, post-washing, and in its final form as a kale chip for further inspections.
The pre-washed samples confirmed the high level of infestation reported by kosher inspectors in other circumstances when dealing with organic kale; the post-washed samples indicate a level of infestation predictably lower but nevertheless above the threshold of tolerance generally agreed upon by kosher certifying agencies. The final, protracted drying process, however, which converts this leafy green into a brittle chip, also succeeds in essentially disintegrating the remaining aphids. Since the insects have essentially dried to the point of decomposition, kosher law discounts their presence and the kale chips are determined to be acceptable. This finding is consistent with other drying procedures that meet the same specifications of time and temperature as this one.
Kosher Status of Inactive Ingredients: Solvents, Diluents, and Excipients
Many formulations of nutritional products contain ingredients used to support, facilitate, or encourage the digestion of whatever main, or “active” ingredient is being promoted for the health of the consumer. Stevia, for example, a botanical extract, is a sweetener used by consumers as an alternative to sugar. One common form of packaging of the product is in single-serve packets, useful to add to a cup of tea or coffee, and essentially identical to the single-serve packets used to package standard table sugar (sucrose) and artificial sweeteners. Stevia, however, is many times sweeter[i] than standard sugar, and volume of stevia needed to sweeten one’s coffee is significantly less than that of standard sugar. If a packet were entirely filled with stevia, the tea or coffee would be insufferably sweet. Therefore, stevia is mixed with a carrier, also referred to as a diluent, to enable, on a very practical level, the distribution and use of this otherwise barely tangible portion. In this case, maltodextrin and dextrose, both starch derivatives, are commonly used and are generally considered kosher (in some parts of the world lactose, a dairy sugar, is used as a carrier for alternative sweeteners. Lactose bears some of the kosher restrictions placed on dairy derivatives, as elaborated above in the case study “Ashwagandha Extract from India”) so although potential kosher is much less desirable.
This dynamic is familiar to anyone involved in the formulations of nutraceuticals and nutritional supplements. Below is a list of a few of the common carriers, a brief summary of their manufacture, and observations on their kosher status. Note: Any nominally kosher product must still be produced on equipment that has also been deemed appropriate for the manufacture of such products and any materials the product comes in contact with must also be kosher.
Ethanol
With specific commercial production conditions, and with the help of a few additives, sugar can be biochemically converted to ethanol. Industrial production of ethanol typically draws on the least expensive feedstock that can readily provide a sugar source. Local agricultural conditions, habits of planting, and other economic considerations have influenced different industrial producers to adopt different feedstocks, depending on the region.
Although sugar itself (for example, in the form of sugarcane) is often the raw material of choice, starches such as wheat, corn or barley are, in some regions, plentiful and can yield a sugar source through a well-established process involving enzymatic degradation of starch. Lactose, which is the sugar separated from whey, can furnish ethanol and such whey would be considered dairy according to kosher law. Wine can be distilled to yield a high-purity ethanol product, a practice centered mostly in western and southern Europe, and would be considered non-kosher unless some extremely expensive procedures were used.
Gelatin
Gelatin is used in hard and soft-gel capsules, as a gelling agent, and in other applications. It is manufactured from the hydrolysis of collagen, which is a protein in the connective tissue and flesh of animals.
A basic feature of kosher law bears reiterating here: the Bible differentiates between animals that are kosher and those that are not kosher. Those that are kosher must be slaughtered, and the act of slaughter must meet a set of narrow and demanding conditions. Cows are kosher and pigs are not.
Gelatin, which, like collagen, is found in connective tissue, is traditionally obtained either from bovine (cow) porcine (pig) or, less frequently but increasing over time, from fish sources. It has numerous applications in nutritional food products. Collagen is used in products designed to alleviate joint pain, reverse or delay muscle loss, and heal wounds. The health benefit of bone broth, a product popularized through the Paleo diets, is based on collagen.
One source of commercially produced gelatin is bovine hides. The hide of a cow, in kosher law, is considered a component of the cow and therefore, on the face of it, the hides would be required to be obtained from cows that are kosher slaughtered. However, to obtain collagen the hides are subjected to an aggressive chemical/caustic treatment; the collagen is isolated from that substance.
Some rabbinic scholars have argued that even if the hides were obtained from non-kosher-slaughtered animals, the dissolution of the hides in the caustic results in the hides losing their identity as a non-kosher substance – as a food entirely – and therefore the collagen isolated from the hides should be considered a “new” substance, unrelated, from a kosher legal perspective, to the original non-kosher substance.
This position has not been accepted by the major global kosher certifying agencies. The general practice among these agencies is to insist, as a criterion of their certification or acceptance of collagen, that hides be sourced from cows that have been slaughtered in accordance with kosher law. Fish gelatin, obtained from kosher fish, is another popular source of kosher gelatin. However gelatin from shellfish or from fish like catfish are not kosher.
Glycerin
Glycerin (1,2,3 propanetriol) is odorless, mildly sweet, and hygroscopic (it retains moisture) and, among other applications, is commonly used to deliver the active substance promoted in liquid nutritional formulations. Glycerin is produced from the hydrolysis of fats and oils, and is a byproduct of biodiesel production. It can be obtained either from animal fats or botanical sources such as palm, coconut, or soybean oil. Glycerin from animal fat is non-kosher; when obtained from vegetable oil, on equipment that is dedicated to vegetable oil processing, glycerin can be kosher.
When Magnesium and Aluminum Stearate is Non-Kosher
Magnesium and aluminum stearate are used in powder formulations to prevent the product from adhering to processing equipment, and occasionally as an anti-caking agent. Hydrolysis of fats and oils (besides yielding glycerin, as cited above), yields fatty acids. The hydrolysis of tropical oils as well as tallow (animal fat) yields a high volume of C:18, or stearic acid. If the raw material for the stearic acid were tallow the stearic acid would be considered non-kosher.
Status of Uncertified Nutraceuticals and Functional Foods
What if a person is suffering from indigestion, and her health practitioner suggests taking a probiotic – but no kosher certified product is available? What about someone suffering from joint pain, who is told that he should take glucosamine, a crustacean derivative? Someone suffering from anxiety is told that flower essences soaked in brandy (a non-kosher wine product) will fix their problems. Does kefir (a cultured dairy product) require certification?
Although the primary function of a kosher certifying agency is to provide supervision services to client companies, in the last ten to twenty years major agencies have also invested in resources that provide education and, very often, specific guidance to consumers on practical aspects of kosher law. The need for such a resource cannot be better illustrated than through the new choices presented to consumers by the wide availability of nutraceutical and dietary supplement products.
Kosher law provides flexibility for someone who is struggling with health problems and seeks to heal, alleviate, or prevent those problems with nutritionally fortified foods or supplements. The rules determining when to permit a non-kosher or otherwise uncertified product are complex. The type and severity of the health condition, the availability of a kosher certified alternative, the nature of the uncertified product, and the likelihood that the uncertified product will deliver on its claims are among the factors that govern its acceptability. Historically the answer to such questions was provided by the local rabbinic authority, and generally that continues to be the case. In the contemporary marketplace, however, when the knowledge of technology and processing methods used in the production of nutraceutical products is accessible only to those who visit the factories producing those products, questions about the viability of a nutritional supplement are often directed not to the local rabbinic authority but to other resources such as the consumer hotlines set up by OU Kosher and the various kosher supervisory agencies.
References
Abdul Wahab Mohammad, Norhazwani Mohd. Suhimi, Abdul Ghani Kumar Abdul Aziz and Jamaliah Md. Jahim, 2014. Process for Production of Hydrolysed Collagen from Agriculture Resources: Potential for Further Development. Journal of Applied Sciences, 14: 1319-132
Lytton, Timothy D. Kosher: Private Regulation in the Age of Industrial Food. Harvard University Press, 2013
Rowe, Shekey, and Quinn (Eds.) Handbook of Pharmaceutical Excipients – Sixth Edition. Pharmaceutical Press 2009