In this article, Bimini’s dosage-form pet health supplements are intended to provide non-nutritional structure and/or function benefits and are not classified under the food category. Bimini’s treats provide nutritional value with supported nutritional claims.
Making the Grade
Bimini Pet Health, a Topeka, Kansas-based manufacturer of dosage-form pet health supplements, recognizes the importance of making safe products that our pets ingest. Although pet health supplements are not classified as food and are not required to be compliant with 21 CFR, Part 117, the federal code that regulates humans’ food, Bimini adheres to and is audited on the basis of 21 CFR part 117 nonetheless. In its approach to manufacturing, Bimini believes there should be no difference in the control of what pets ingest versus what humans consume. Everything Bimini produces is made at its cGMP (current Good Manufacturing Practice) certified facility, which is also USDA inspected and FDA registered. The products are made with responsibly procured ingredients. Every ingredient and the resulting products are stored, handled, processed and transported in a manner consistent with applicable federal laws. Furthermore, as a leader in the pet health supplements sector, Bimini also intends to become 21 CFR, part 111 (cGMP for Human Health Supplements) compliant within the next year and has begun identity testing on all incoming raw ingredients before using in production.
Exercising Care and Caution
In addition to what is required by the cGMPs, Bimini applies a positive release policy to the process of preparing and releasing a finished product for shipping. A finished product lot must remain in Bimini’s warehouse until microbiological test results validate the product’s safety. Bimini tests its products for pathogenic E. coli (not all E. coli are pathogenic), aflatoxin and salmonella. Testing for E. coli and salmonella is important because human clients handle the products they give to their pets. Bimini does not want to expose humans or animals to potentially harmful microbes.
At high levels, aflatoxins can cause death or serious illness in pets. Aflatoxins are produced by certain types of molds. To that end, Bimini commissioned a diagnostic testing company to develop an Aflatoxin testing method that is specifically suited to being used with complex matrices such as soft chews and powder mixes that Bimini produces. Bimini goes the extra mile in testing the safety of its pet products. Most manufacturers of pet health supplements do not test for aflatoxin or wait until their product has been tested to ship it.
All the Way Home
Safety with what we give our pets shouldn’t end when the consumer leaves the store. Bimini avoids using chemical preservatives to ensure shelf-life stability. Instead, the company employs more passive approaches to maintaining a safe product on the shelf. In that regard, water is key to microbial growth and “water activity” is the measure of available water for microbial growth. Bimini’s products are designed to have very low water activity levels, even lower that what the FDA recommends for human food. These low water activity levels do not support microbial growth that can lead to illness, including bacteria, mold and yeast.
People now regard their pets as members of their family. We want our dogs and cats to be as healthy as they can be, so they can be with us as many years as possible. Bimini is here to help us give our pets supplements that meet the highest quality standards.