Tallow
What is tallow and why am I writing about it? Personally, I prefer to focus on botanical ingredients and finished products, but tallow is being heavily promoted in social media circles as a beneficial topical product and many herbalists are using it in various cosmetics. Simply put, tallow is solid animal fat, typically derived from our domestic animal consumption (beef, sheep) and a byproduct of the rendering process. Tallow is used in many industries but for this post, I’m focusing on the use of it as a cosmetic ingredient, and specifically beef tallow. Recently, I’ve seen several advertisements from small herbal cosmetics manufacturers promoting their own tallow products. Many are small farmers who make the tallow themselves from their own beef, supplementing a farm raised meat business and creating additional income streams from the byproducts.
As an animal product, FDA has concerns about using cattle materials, namely the risk of BSE (bovine spongiform encephalopathy), and preventing any possibility of using infected product in food or cosmetics. BSE, a prion disease in cattle, is linked to Creutzfeldt-Jakob disease in humans, a rare but fatal brain disease, and for this reason, FDA and other agencies provide strict enforcement of cattle product regulations. For cosmetic use, these restrictions are detailed in 21 CFR § 700.27, Use of prohibited cattle materials in cosmetic products. This section specifies what is and is not allowed and these items are risk based. In some cases, FDA will exempt small or very small operations from requirements, however in this instance, there are no exemptions and every producer, regardless of size, must follow these regulations. Tallow, per this regulation, means “the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissues. Tallow must be produced from tissues that are not prohibited cattle materials or must contain no more than 0.15 percent insoluble impurities (AOCS Official Method CA 3a-46), American Oil Chemists Society, 5th Edition, 1997. Tallow itself is not a prohibited cattle material when it meets this specification, but it must not be made from cattle products that are prohibited. This is clearly stated in 21 CFR § 700.27 (b) (1) “No cosmetic shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials.” In 69 Federal Register 42256, FDA discusses the commercial processes employed to create tallow (hydrolysis, transesterification, and saponification) and deemed them sufficient to render the risk of transmission low. However, there are many websites detailing the process to make your own tallow at home that simply involve heating suet. If this process is used to make tallow that then becomes a cosmetic ingredient, the risk increases.
What are these prohibited cattle products? The list is based on cattle products and conditions that may harbor infection with BSE or indicate infection with BSE. The actual materials are listed in the regulation, those parts of the cattle where the prion resides, brain tissue, spinal cord, and others. The prohibited conditions are possibly more applicable to the small producer. Material taken from non ambulatory cattle, non inspected and passed cattle, and cattle over 30 months of age is prohibited which may limit the home producer if they are making tallow for commercial use. (Anything produced for individual use is NOT affected by this regulation.)
An herbalist offering cosmetics in their small commercial line may feel secure in their exempt status from MoCRA (Modernization of Cosmetics Regulation Act of 2022) requirements for registration and listing, and current Good Manufacturing Practices. But if some of the products offered include beef tallow, it must meet the specifications indicated above. When produced on site, records proving that it was manufactured free from prohibited cattle materials must be maintained. If purchased, then receiving records must prove that the product received is acceptable and free from prohibited cattle materials. Test results must be available that prove acceptable insoluble impurities and all records generated must be accessible to FDA. Though rare, the severity of BSE and Creutzfeldt-Jakob warrants the restrictions placed on this ingredient.
This week Elizabeth and I will be at the Great Lakes Herb Faire in Chelsea, MI. If you happen to be attending, please stop by our booth and be sure to attend Elizabeth’s presentation on Barberry!