ANSWERS Pet Food Disputes FDA Claims

ANSWERS Pet Food Disputes FDA Claims

Jul 23, 2019Andrew Kim

As a leader in pet nutrition, Healthy Spot will always provide the latest updates and our thoughts on important topics to help you make the healthiest lifestyle choices for your pet.

Founded in 2009, ANSWERS Pet Food is a Green Certified, family-owned company based in Fleetwood, PA that offers non-GMO recipes made from known quality sources. We sell the following ANSWERS™ products...

  • Additional Goat’s Milk: raw, unpasteurized goat milk from grass-fed goats raised on local farms that have a Global Animal Partnership (GAP) rating or a Certified Humane Rating.
  • Detailed Fermented Fish Stock: sourced from line-caught whitefish and sardines in North Atlantic waters.
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    On July 8, 2019 Lystn, LLC d.b.a & ANSWERS™ Pet Food announced that they have “filed a Declaratory Judgement Complaint" and are "seeking Injunctive Relief against the Food and Drug Administration (FDA).

    The complaint disputes the FDA and AAFCO’s (Association of American Feed Control Officials) adopted zero tolerance standard for Salmonella in pet food. ANSWERS™ believes this standard is noncompliant with federal law, scientifically unsound and goes beyond the FDA’s range of “power as delegated by Congress.

    ANSWERS™ is made up of a professional team with over 50 years of experience in the raw pet food industry. Armed with a scientist on staff who oversees formulation and quality assurance and a veterinarian who is available to consult with clients’ vets, we support ANSWERS approach to meet your four-legged friend’s health care needs. We are sharing the details around this complaint because we offer two different ANSWERS products in all of our locations as a safe, raw food option for your dog or cat.

     BACKGROUND

    COMPLIANCE POLICY GUIDES

    Back in 2007, a national crisis ensued as more than 150 brands of pet food were recalled due to melamine exposure.

    As a result of this nationwide issue, the United States Congress passed 21 U.S.C. § 2102- a law which instructed the FDA to create “formal rulemaking relative to pet food and animal feed”. In lieu of making these rules, the FDA turned to Compliance Policy Guides (CPGs). These guides are defined as “non-binding” industry suggestions that explain “regulatory issues related to the FDA laws or regulations” and “advise FDA’s inspection and compliance staffs”.

    The problem with relying on CPGs is that they do not have any scientific foundation, and cannot be legally enforced. However, the FDA does enforce these policies upon companies and manufacturers despite their illegitimate legal status.

    ADULTERANTS & SALMONELLA

    There are around 2,500 strains of Salmonella, most of which are not harmful to humans or our fur-iends. This makes it very important to both identify the type, and amount, of the Salmonella bacteria during testing to figure out whether it is toxic or not.

    Salmonella and other microorganisms can be considered what the law refers to as “adulterants”.

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines “adulterants” as any substance that is poisonous or injurious. This act prohibits the distribution and sale of any food that contains adulterants, but only if they are added. However, if the substance is naturally occurring (like Salmonella can be), then it is not considered an adulterant.

    In fact, even the United States Department of Agriculture (USDA) does not consider the presence of Salmonella in human food illegal. This is due to the fact that it can naturally occur in some food and that proper scientific testing will result in positive results for Salmonella even when it's dead and not harmful.

    Thus, the FDA’s policy conflicts with the law, as it states that the FDA considers a pet food to be adulterated...when it is contaminated with any Salmonella”.

     RESULTS

    While initial testing by a state laboratory confirmed the presence of Salmonella on a product sample, there wasn't enough sample material to identify the strain or to measure the amount of bacteria. Further testing was conducted on more product sample by an independent laboratory, which found no presence of Salmonella after four tests in a row. This “consistent non-finding” of Salmonella in ANSWERS’™ foods calls into question the possibility of cross contamination that may have happened in the first laboratory, or during other handling or transportation of the product.

     ANSWERS'™ RESPONSE

    In order to sanitize their foods, ANSWERS™ uses a successful “alternative approach through fermentation, Hurdle Technology and proprietary processes for protection” which helps the products retain all their healthy nutrients, which tend to deplete in traditional heat processing.

    In response to the FDA’s claims, Keith A. Hill, President of Lystn, LLC, says that, "ANSWERS™ Pet Food would be the first party to initiate a recall if there was any indication of one of their products being a likely health risk to either pets or their owners, but when the science proves otherwise as provided by federal law, a manufacturer should not be coerced based on administrative policy view in contrast to the law."

     

    As a retailer of ANSWERS and as your trusted resource for updates in the raw pet food space, Healthy Spot will continue to share updates on the progress of this complaint to ensure that our customers continue to remain well-informed. If you are still unsure about whether a raw diet is appropriate for your pet, we encourage you to consult with a Healthy Spot team member at any of our locations. Click here to find your nearest store.



    Sources:

    https://www.prnewswire.com/news-releases/answers-pet-food-challenges-the-fda-for-the-publics-freedom-to-choose-safe-healthy-raw-pet-food-300881182.html

    https://www.who.int/csr/media/faq/QAmelamine/en/ 

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/manual-compliance-policy-guides/foreword-compliance-policy-guides-cpgs

    https://www.law.cornell.edu/uscode/text/21/342 

    https://truthaboutpetfood.com/wp-content/uploads/2019/07/Answers-Complaint.pdf

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