Decoding Organic Dairy Healthcare Product Labels

Introduction

Prevention and early intervention are important in organic dairy herd health management. Noting health issues early is critical, as many organic approved treatments work most effectively when used in the initial stages of illness.

When animal health issues arise, it is necessary to know which tools are available for use in organic systems. With so many products on the shelves, how can you determine which products are allowed? Having a basic understanding of how to review healthcare labels for compliance with the USDA National Organic Program (NOP) Rule can help you easily weed out the products that are prohibited and narrow down the list of what is permitted for use in certified organic production. As always, be sure to check with your certifier before using any product -- many certifiers maintain lists of approved healthcare products that farmers may request.

Is it a Feed Supplement or a Health Care Product?

There are several steps in reviewing a product to determine if it is allowed for use as a health care input. The first step is to see if it will be used as 1) a supplement or 2) a health care product.

If it is a feed supplement or additive being mixed with the feed and/or fed to livestock on a regular basis, it must meet all the requirements of organic livestock feed. The USDA NOP Rule regarding livestock feed (Section 205.237) requires that all agricultural ingredients are certified organic, and that only synthetic substances allowed under Section 205.603 may be used. 

Further, feed supplements are defined in the organic standards (refer to Section 205.2 of the NOP Rule for a list of defined terms) as "combinations of feed nutrients added to livestock feed to improve the nutrient balance or performance of the total ration and intended to be: (1) diluted with other feeds when fed to livestock; (2) offered free choice with other parts of the ration if separately available; or (3)  further diluted and mixed to produce a complete feed."

Feed additives are defined as "substances added to feed in micro quantities to fulfill a specific nutritional need; i.e., essential nutrients in the form of amino acids, vitamins, and minerals." 

Reading Ingredient Labels

Is it active or non-active?

Once it is clear that the material is a health care product, the next step is to read the product label to determine which ingredients are active and non-active.

Active ingredients are, of course, the ones that are active and exert therapeutic effects.

Non-active ingredients (also called "excipients") are things like carriers and fillers that do not have any medicinal effects, but help deliver the active ingredients to the desired site in the animal. Why does this matter? Active and non-active ingredients are subject to different criteria when reviewed for compliance in organic systems. Sometimes, active and non-active ingredients are specified on the label, but not always. For some products, it can be tricky to determine this so, when in doubt, it may be necessary to call the manufacturer for this information.

Once all ingredients have been sorted into active and non-active categories, you can then look more closely at the active ingredients as the next step.

Are the active ingredients nonsynthetic or synthetic?

According to the NOP, a nonsynthetic material (also referred to as "natural") is defined as a substance derived from mineral, plant or animal matter. A synthetic material is defined as "a substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral sources, except that such term shall not apply to substances created by naturally occurring biological processes." (Section 205.2 of the NOP Rule is a list of defined terms).

In general, if an active ingredient is nonsynthetic, it is allowed. There is currently only one nonsynthetic material prohibited for use in organic livestock production – Strychnine – and it is listed in Section 205.604 as prohibited. So, with the exception of this one material, all other nonsynthetic materials are allowed for livestock use.

If an active ingredient is synthetic, it must be listed in Section 205.603 of the NOP Rule. This section is the part of the National List that includes all of the synthetic substances allowed for use in organic livestock production, when appropriate and used in accordance with the label. In addition, many of the items on the list have an annotation, which place specific restrictions on use of the substance for treating organic animals. For example, flunixin is on the list but requires a withdrawal period of at least two times that required by the FDA. Oxytocin is also on the list, but is only allowed for "postparturition therapies."

If an active ingredient is synthetic and that material is not on the National List, then the next step is to determine if the product is prohibited.

Let's work through a few fictitious examples.

Fix-A-Cow Electrolyte

Ingredients: Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride Dihydrate, Water

The first four substances are all active and are electrolytes, which are listed under Section 205.603(a)(8). The annotation says, "Electrolytes without antibiotics." Since this product does not contain an antibiotic, this product would be approved.

Here is another electrolyte product; this one for calves.

Calf Re-Store Electrolyte

Ingredients: Dextrose, Glycine, Sodium Bicarbonate, Kaolin

In this case, all of the ingredients are active. The dextrose, sodium bicarbonate, and kaolin are all nonsynthetic and allowed. However, glycine is a synthetic amino acid not listed in Section 205.603. Therefore, this formulation would be prohibited.

Reviewing the Excipients

If you are reviewing a multi-ingredient product and have determined active ingredients to be nonsynthetic or synthetic and listed on 205.603, you will next want to look at the non-active ingredients.

Non-active ingredients that are nonsynthetic are allowed when used in products containing approved active ingredients.

Non-active ingredients that are synthetic are not confined to the National List. Synthetic excipients are allowed in products used to treat organic animals when they are:

1. Identified by the FDA as Generally Recognized as Safe (GRAS).
2. Approved by the FDA as a food additive (Everything Added to Food in the United States or EAFUS).
3. Included in the FDA review and approval of a New Animal Drug Application (NADA) or New Drug Application (NDA).

Here are a couple of tips to consider when looking up excipients on the sites above.

• If a material cannot be found on the GRAS or EAFUS lists, remember that some substances have synonyms. You can search for synonyms through a search engine such as ‘Google.’
• The GRAS list is not alphabetized. To find a specific item, press ‘Control F’ and type a word or part of a word into the ‘Find’ box that pops up.
• The EAFUS list is alphabetized and includes almost 4,000 items with their associated CAS numbers (Chemical Abstract Service Registry Numbers).
• Use the CAS numbers to locate ingredients when necessary. This information would be available from the product’s manufacturer. The CAS number is useful when there are multiple forms of a material. The EAFUS list can be sorted by CAS number as well to make searching easier.

Let's take a look at some more examples.

Flo’s Garlic Tincture

Ingredients: Garlic, Glycerin

1. The garlic is active and nonsynthetic. It is allowed, but does the garlic have to be organic? In the case of healthcare products, agricultural ingredients do not have to be organic, they only have to be non-GMO. (Agricultural ingredients in feed additives do have to be organic. For example, if molasses is fed to an animal on a daily basis, it is considered a feed additive and would have to be organic. However, if molasses is added to a cow’s water after calving only, it is a healthcare use and does not have to be organic.)
2. The glycerin in this case is synthetic and non-active. This is important because it determines which list will be used to review it. Glycerin is not allowed in products as an active ingredient, unless it is in a livestock teat dip (Section 205.603(a)(12). However, glycerin is allowed as a non-active ingredient as it is listed on EAFUS.

Conclusion: Flo’s Garlic Tincture is approved for use in organic livestock production.

The following example is a little more complicated.

Happy Cow Udder Rub

Ingredients: Water, Peppermint Oil, Calendula Oil, Eucalyptus Oil, Phenoxyethanol, Polyacrylic Acid- Sodium Salt, Sorbitan Mono-Oleate

1. Determine the active and non-active ingredients. The oils (peppermint, calendula, and eucalyptus) are the active ingredients. These are all nonsynthetic and allowed for use.
2. Determine if the non-actives, which are synthetic, are GRAS, EAFUS or NADA. Since the EAFUS is the largest list, it is generally easiest to start there. Both the polyacrylic acid-sodium salt and the sorbitan mono-oleate are listed on EAFUS, so these substances are allowed. However, phenoxyethanol is not found on EAFUS. Here’s where it is helpful to look up any possible synonyms for phenoxyethanol. A quick online search determines that this material is also called "ethylene glycol monophenyl ether" and is listed on EAFUS. At this point, it would be recommended to call the manufacturer to obtain the material's CAS number to ensure that this is the actual substance in the product.
3. The CAS number from the manufacturer matches that on the EAFUS list.

Conclusion: Happy Cow Udder Rub is approved for use in organic livestock production.

While farmers should rely on their certifiers to do the type of product review outlined above, it is helpful to have an understanding of what makes a product allowed or prohibited. It is important to remember that farmers are required to list all products that might be used in their OSP each year. This allows the certifier to review the products and approve them prior to their use. There are some livestock products that are OMRI (Organic Materials Review Institute) listed and some certifiers publish lists of allowed and prohibited products for their farmer clients.

Remember, with any product listing, there are no claims made on a product's efficacy. It is strictly a listing of what is allowed and prohibited. Farmers should decide what products to use as part of their treatment plan in consultation with their veterinarian. A wide variety of products are helpful when used as part of a holistic management plan that includes good management, organic feed, clean environments, and preventive practices.

References and Citations

• Everything Added to Food in the United States/EAFUS [Online]. US Food and Drug Administration. Available at: http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm115326.htm (verified 07 June 2012).
• Generally Recognized as Safe (GRAS) [Online]. US Food and Drug Administration. Available at: http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ (verified 07 June 2012).
• New Animal Drug Applications [Online]. US Food and Drug Administration. Available at: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/NewAnimalDrugApplications/default.htm (verified 07 June 2012).
• United States Department of Agriculture. 2000. National organic program: Final rule. Codified at 7 C.F.R., part 205. (Available online at: http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&sid=3f34f4c22f9aa8e6d9864cc2683cea02&tpl=/ecfrbrowse/Title07/7cfr205_main_02.tpl) (verified 16 Dec 2015).