Raaw Energy LLC MARCS-CMS 723820 — August 21, 2026

WARNING LETTER

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• Delivery Method: VIA EMAIL NO HARD COPY TO FOLLOW
• Product: Animal & Veterinary; Food & Beverages

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• Recipient: Kitt A. Schulman; Owner; Raaw Energy LLC; 967 Route 524; Adelphi, NJ 07710-0276; United States; (b)(6), (b)(7)(C)

• Issuing Office: Center for Veterinary Medicine; United States

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WARNING LETTER
CMS # 723820

August 21, 2026

Dear Kitt Schulman,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your pet food manufacturing facility located at 967 Route 524, Adelphi, New Jersey, from January 13 through January 22, 2026, following a consumer complaint and state sample results regarding your products. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). As of the date of this letter, we have not received your written response to the FDA 483.

During the inspection, the FDA investigator found evidence of significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The observed conditions cause the animal food at your facility to be adulterated because the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.¹

Additionally, in response to the consumer complaint, the Connecticut Department of Agriculture (CDoAg) and New Jersey Department of Agriculture (NJDA) collected pet food product samples from the consumer and your facility. Analysis of the frozen, unopened pet food finished products revealed the presence of one or more pathogens: Salmonella, Listeria monocytogenes (L. monocytogenes), Campylobacter jejuni (C. jejuni). FDA notified you of these results on January 8 and 22, 2026, and issued a public advisory regarding these products on January 23, 2026.² On April 7, 2026, NJDA conducted follow-up sampling that found additional products contained L. monocytogenes. FDA notified you of the additional sample findings on May 13, 2026. FDA considers these products sampled by CDoAg and NJDA to be adulterated because they bear or contain a poisonous or deleterious substance which may render them injurious to health.³ On May 22, 2026, FDA updated its public advisory, and you voluntarily recalled all products manufactured between July 17 and December 23, 2025, and one lot manufactured on March 31, 2026.

The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.⁴ Furthermore, the doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated is prohibited.⁵

You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.

Adulterated Animal Food

Pathogen Findings in Samples

On December 18, 2025, CDoAg collected closed sample (b)(4), consisting of Chicken Medley dog food, lot 7.17.25, in response to a consumer complaint regarding gastrointestinal illness in their dog after consuming the same product lot. Sample analysis conducted by CDoAg revealed the product contained Salmonella Infantis, L. monocytogenes, and C. jejuni. CDoAg issued a withdraw from distribution notice to you for this product lot on January 14, 2026.

On December 22, 2025, NJDA sampled dog food products from your facility after receiving notification of the consumer complaint. Sample analysis conducted by NJDA revealed two products contained L. monocytogenes. NJDA issued a stop sale for these products on January 8, 2026:

• Sample (b)(4), Chicken Medley, lot (b)(4).
• Sample (b)(4), Salmon, lot 12.5.25.

On January 8, 2026, NJDA collected additional samples of dog food from your facility. Sample analysis conducted by NJDA revealed five products contained L. monocytogenes and one product also contained Salmonella Kentucky. NJDA issued a stop sale for these products on January 20, 2026:

• Sample (b)(4), Salmon dog food, lot 12.12.25.
• Sample (b)(4), Chicken Medley, lot 12.12.25. This product also contained Salmonella Kentucky.
• Sample (b)(4), Beef Chicken Tripe dog food, lot 12.23.25.
• Sample (b)(4), Beef Chicken Medley dog food, lot 12.16.25.
• Sample (b)(4), Beef Turkey Medley dog food, lot 12.18.25.

On April 7, 2026, NJDA collected additional samples of dog food from your facility. Sample analysis conducted by NJDA revealed three products contained L. monocytogenes. NJDA issued a stop sale of these products on April 21, 2026:

• Sample (b)(4), Chicken Medley, lot (b)(4).
• Sample (b)(4), Salmon, lot 12.20.25.
• Sample (b)(4), Beef Turkey Medley, lot 3.31.26.

FDA’s Office of Regulatory Testing and Surveillance reviewed and concurred with the state sample analyses. The pet food described above is adulterated because it contains pathogens that render the food injurious to health.⁶

Insanitary Conditions

During the inspection of your facility, the FDA investigator observed insanitary conditions during the manufacture of Beef Chicken Medley on (b)(4). The conditions described below demonstrate the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.⁷ The FDA investigator observed your manufacturing process does not include any steps to control environmental pathogens in your in-process and finished animal food.

1. The FDA investigator observed conditions that may cause contamination of animal food from the environment. For example:

a. On January 14, 2026, the FDA investigator observed an employee using a high-pressure water hose to clean a shovel used to discard product that fell on the floor, causing overspray and aerosolized water to contact uncovered finished product in the hopper and extruder, and nearby uncovered containers of chicken.
b. Plastic totes used in the production of pet food were cracked and exposed ingredients inside the tote to the floor. Employees also stacked the uncovered totes on top of one-another after the totes had been sitting on the floor, thus exposing the in-process animal food in the lower totes to the contaminated bottom of the tote above. In addition, employees reused the plastic totes throughout the production day without cleaning and sanitizing the totes when they may have become soiled or contaminated.
c. The concrete and stone floor of the manufacturing area was pitted and contained deep cracks. The floor was also not properly sloped to allow adequate drainage causing water and blood to pool on the floor throughout the production day. The FDA investigator observed one of the totes sitting in a pool of water and blood on the floor before being stacked inside another tote and subsequently reused in the production of pet food. You also stored in-process animal food in cracked plastic totes and open plastic bags directly on the floor of the manufacturing area by the standing blood and water.
d. Condensation from the overhead air conditioning dripped directly on to raw chicken and other ingredients. The condensate from the air conditioner also dripped onto a rusty metal rack that subsequently dripped onto raw chicken ingredients.

2. The FDA investigator observed that raw ingredients and in-process materials may have been contaminated by the uneven, porous, and/or pitted areas on manufacturing equipment, tools, or utensils. Rust, and other areas that are not easily cleanable, may become harborage areas for pathogens. For example:

a. The (b)(4), used to grind meat ingredients, had apparent rust on food contact surfaces and uneven edges with missing and bent metal at the chute where food is dispensed.
b. Food contact surfaces of equipment and utensils contained apparent rust on the extrusion point of a grinder and on a pitchfork used for chicken ingredients.

3. You distribute animal food that is not shelf stable (i.e., could support the growth of pathogens at room temperature). You ship products from your facility in a frozen state. However, you use an unrefrigerated truck to distribute these products as far away as Maine and Vermont from your manufacturing plant in New Jersey. You do not have any practices in place to ensure that your finished products remain under appropriate time and temperature conditions to prevent the growth of pathogens in your products during transportation.

FDA conducted whole genome sequencing (WGS) analyses of the pathogens found in your products. FDA provided you with the results of these analyses on February 11 and May 13, 2026. The May 2026 WGS analysis shows a very close genetic relationship (b)(4) between the L. monocytogenes strain contained in the Chicken Medley product with lot code 7.17.25 and the L. monocytogenes strains contained in three Salmon product samples with lot codes 12.5.25, 12.12.25, and 12.20.25. (b)(4). These findings document that a nearly identical strain of L. monocytogenes was present in products made using two different recipes with no common ingredients, manufactured between (b)(4) and (b)(4). These findings are consistent with the presence of a resident strain of L. monocytogenes in your facility, further indicating insanitary conditions.

Public Health Impact of Pathogens

The presence of pathogens in dog food is a concern because it may cause adverse health effects to animals consuming the dog food and/or humans handling the dog food. Your dog food products present a risk to human and animal health because they contain animal proteins that have not undergone a process to control pathogens. The dog foods you manufacture are produced without measures routinely used by pet food manufacturers to control harmful pathogens. Furthermore, the practices described above are ways in which the dog food you manufacture may become contaminated by pathogens. It is therefore essential that your facility has measures in place to prevent and reduce pathogenic contamination of your products and facility.

Pathogens found in your finished products include the following:

Salmonella is a pathogenic bacterium that can cause serious and sometimes fatal infections in both humans and animals. Infections can be especially serious in young children, elderly people, and others with weakened immune systems. The association between human illness or outbreaks of salmonellosis and Salmonella-contaminated pet food is well established.⁸ The association between Salmonella-contaminated pet food and pet illness has also been shown.⁹

L. monocytogenes is a pathogenic bacterium in the environment and may be introduced into a food manufacturing facility from raw materials, humans, or equipment. Without adequate sanitation, it can proliferate in food manufacturing facilities and subsequently contaminate food. Handling or consuming contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions. Pets infected with L. monocytogenes can experience symptoms ranging from diarrhea and/or vomiting to severe illness, such as meningitis, or death.

C. jejuni is one of the most common bacterial causes of diarrheal illness in humans. Symptoms of campylobacteriosis infection can include fever, abdominal cramps, and diarrhea, which can lead to health complications such as irritable bowel syndrome, temporary paralysis (Guillain-Barré Syndrome), arthritis, urinary tract infections, and meningitis. Dogs infected with C. jejuni can develop symptoms including diarrhea, vomiting, tenesmus (straining), lethargy, and fever.

Generally, humans may become infected by these pathogens through direct contact with contaminated food or cross-contamination from dogs. Dogs may shed bacteria through feces and/or saliva and contaminate the household environment even though the dog may be asymptomatic.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address any violation may lead to legal action, including without limitation, seizure and injunction.

For more information about FDA’s current thinking and resources for industry, see:

• For Industry | FDA (https://www.fda.gov/animal-veterinary/resources-you/industry).

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe your products are not in violation of the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

The FDA, Center for Veterinary Medicine, Office of Surveillance and Compliance, is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.

Please direct your electronic correspondence to Compliance Officer Andrew J. Howard at Andrew.Howard@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Andrew J. Howard by telephone at (410) 779-5125, or by the email above.

/S/

Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration

Cc:
Edward Wengryn, Secretary
New Jersey Dept of Agriculture
PO Box 330
Trenton, NJ 08625
(b)(6), (b)(7)(C)

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1 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C § 342(a)(4)].

2 https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-advisory-do-not-feed-eight-lots-raaw-energy-dog-food-due-contamination-harmful-bacteria.

3 See Section 402(a)(1) of the FD&C Act [21 U.S.C. § 342(a)(1)].

4 See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

5 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].

6 See Section 402(a)(1) of the FD&C Act [21 U.S.C. § 342(a)(1)].

7 See Section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)].

8 For example, see the Centers for Disease Control and Prevention information on past Salmonella outbreaks related to pet food: https://www.cdc.gov/salmonella/pet-treats-07-19/index.html (pig ear dog treats), https://www.cdc.gov/salmonella/dog-food-05-12/index.html (dry dog food), https://www.cdc.gov/salmonella/2007/pet-food-9-4-2007.html (dry dog food).

9 https://www.cdc.gov/healthypets/keeping-pets-and-people-healthy/pet-food-safety.html; https://www.avma.org/resources-tools/avma-policies/raw-or-undercooked-animal-source-protein-cat-and-dog-diets.