WARNING LETTER
Synergy Animal Products, Inc.
MARCS-CMS 712860 —
July 16, 2025
Delivery Method:
Via Email
Product:
Animal & Veterinary
Recipient:
Recipient Name
Mark A. Hassler
Recipient Title
President and CEO
Synergy Animal Products, Inc.
1681 Schubert Rd
Bethel
,
PA
19507
United States
synergyanimalproducts@gmail.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
July 16, 2025
Re: 712860
Dear Mark A. Hassler,
This letter concerns your firm’s marketing of adulterated and misbranded animal drugs in violation of the Federal Food Drug and Cosmetic Act (FD&C Act).
The U.S. Food and Drug Administration (FDA) inspected your facility located at 1681 Schubert Rd, Bethel, PA 19507 from September 5, 2024, through September 10, 2024. After a review of the inspection report, and a subsequent review of your website, synergyanimalproducts.com, we have determined that you are marketing drugs for use in animals. Specifically, your website and product labeling establish that your, Ex-Cell Countdown 7000, Natural Cow Herbal Support, Ex-Cell Somaticare, Superior Cow Cream, and Super Cow Udder Mint products are drugs under section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of animals. For the reasons discussed below, these products are unapproved new animal drugs. Introducing or delivering these unapproved new animal drugs for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
This Warning Letter also summarizes violations related to the FD&C Act’s labeling requirements for drugs. You distribute drugs that are misbranded under section 502(f)(1) of the FD&C Act, [21 U.S.C. § 352(f)(1)] because their labeling lacks adequate directions for use.
This Warning Letter also summarizes violations of the FD&C Act’s drug manufacturer registration and listing requirements. You do not comply with sections 510(b) and (j) of the FD&C Act [21 U.S.C. § 360(b), (j)] related to drug manufacturer registration and drug listing, and therefore the drugs you distribute are misbranded under section 502(o) of the FD&C Act.
This Warning Letter also summarizes significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), Parts 210 and 211. Because your methods, facilities or controls for manufacturing, processing, packing or holding drugs do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, [21 U.S.C. § 351(a)(2)(B)].
You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov.
We reviewed your September 28, 2024, response to our Form FDA 483 in detail.
Unapproved New Animal Drug Violations
Examples of claims FDA observed on your website, synergyanimalproducts.com, and your product labeling that show the intended use of your products as drugs include, but are not limited to, the following:
•
Ex-Cell Countdown 7000
o “Ex-cell Countdown 7000 is a broad coverage product that is great when you’re unsure of the problem you are having, as well as stringiness and hard quarters.”
o From your ‘Most Common Recommendations’ infographic:
 “White or Yellow Chunks”
 “High SCC or No Visible Signs”
 “Stringy or Hard Quarter”
 “Thick Consistency”
•
Natural Cow Herbal Support
o “Use for…high somatic cell count, scours…”
o “Scours in Calves”
o “High Somatic Cell”
o “… because of their anti-septic, anti-inflammatory & antibacterial properties.”
•
Ex-Cell Somaticare
o “Use when problems look clear and watery and/or may contain flakes.”
o “This formula is designed to target problems that look clear and watery and/or may contain flakes”
•
Superior Cow Cream
o “… Sore Teats – Flaky Milk – High S.C.C”
o “…works beneath the skins surface at a deeper level than traditional udder creams.”
•
Super Cow Udder Mint
o “Super Cow Udder Mint is not for every mastitis case. In most cases, Superior Cow Cream will work, but if a case is really bad, you want the stronger Super Cow Udder Mint.”
o “… Sore Teats – Flaky Milk – High Somatic Cell Count”
Because your products are intended to diagnose, cure, mitigate, treat, or prevent disease and/or intended to affect the structure or any function of the body of animals, they are drugs within the meaning of section 201(g)(1) of the FD&C Act, [21 U.S.C. § 321 (g)(1)]. These products are new animal drugs under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, new animal drugs must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. The new animal drugs you market are not approved or index listed by FDA, and therefore they are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act, [21 U.S.C. § 351(a)(5)].
The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the FD&C Act, [21 U.S.C. § 331(a)].
Drugs Without Adequate Directions for Use
You distribute drugs that are misbranded under section 502(f)(1) of the FD&C Act, [21 U.S.C. § 352(f)(1)] because their labeling lacks adequate directions for use. Adequate directions for use include, among other things, statements of all intended uses (indications), routes of administration, and frequency of administration in language understandable by laypersons. 21 CFR 201.5.
Your website states: “Q: What are your products used for? A: Our products are a natural support system for dairy animals udder health. Our products are not FDA approved; therefore we cannot make any claims regarding our products’ purpose. It is at the farmers discretion to determine the products use.”
Your attempt to avoid making claims about your products’ uses put animals (and the humans who might consume the byproducts of the dairy cows treated with your products) at risk by not giving users adequate directions for safe use of your drugs. You market your products for use by the general public (laypersons)–who do not know the details of your products’ formulations and how to safely use them–unless you provide that information in the product’s labeling. Although your products are unapproved, they are drugs and must therefore bear adequate directions for use, including statements of their intended uses that are understandable by laypersons.
For example, with respect to your products’ labeling, (including its labels and the labeling on your website):
-
Ex-Cell Countdown 7000
does not have a clear indication statement that is understandable by laypersons (e.g., vague language such as “great when you’re unsure of the problem you are having”,” “stringiness,” and other statements that laypersons may not understand, such as “high S.C.C.”). This product is also missing clear directions on the route of administration.
- “
Natural Cow Herbal Support
” does not have a clear indication statement that is understandable by laypersons (e.g., use of terminology not familiar to laypersons such as, “High Somatic Cell,” and vague language such as “Irregular milk”).
-
Ex-Cell Somaticare
does not have a clear indication statement that is understandable by laypersons (e.g., vague language such as “when problems look clear and watery”) and has no directions indicating how to prepare the product for administration.
-
Superior Cow Cream
does not have a clear indication statement that is understandable by laypersons (“e.g., vague statements such as “Flaky Milk” and terminology not appropriate for laypersons, such as “High S.C.C”) and its labeling contains contradictory directions for frequency of use (1 to 2 fl. oz. after milking for 2 to 5 days as needed, per the label vs. twice a day for 6-10 days, per the labeling on the product’s website at synergyanimalproducts.com).
-
Super Cow Udder Mint
does not have a clear indication statement that is understandable by laypersons (e.g., use of terminology not familiar to laypersons, such as “High Somatic Cell Count,” and vague language such as “Flaky Milk”).
During our review, we noted many other products you sell appear to have similar issues. You should review them all to ensure they contain adequate directions for use.
Drug Registration and Listing Violations
Sections 510(b) and (j) of the FD&C Act [21 U.S.C. § 360(b), (j)] require that manufacturers of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drugs they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act.
None of the animal drugs you manufacture are listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act.
Current Good Manufacturing Practice Violations
Based on the evidence gathered during our inspection, we have determined your firm’s operations are out of compliance with the FD&C Act’s Current Good Manufacturing Practice (CGMP) requirements (section 501(a)(2)(B) of the FD&C Act, [21 U.S.C. § 351(a)(2)(B)]), and the requirements of its implementing regulation for drug products, 21 CFR Parts 210 and 211. Our inspection found that your operations were fundamentally noncompliant with CGMP in that you had no quality unit, had no written procedures applicable to the production and distribution of animal drug products, performed no testing, and kept no records pertaining to the manufacturing of these products.
Your failure to manufacture drugs in accordance with CGMP means there is no assurance they meet the safety requirements of the FD&C Act or have the identity and strength, and meet the quality and purity characteristics, which they are represented to possess. Moreover, as you manufacture drugs for use in food-producing animals (dairy cows), your inadequate controls increase the risk that your drugs will inadvertently enter the food supply.
During the most recent FDA inspection of your facility, our investigators observed specific CGMP violations, including, but not limited to, the following:
1) Failure to establish a quality control unit. (21 CFR 211.22).
Your firm has no quality unit (QU) or any procedures for the responsibilities of a QU (including/but not limited to setting specifications, performing investigations, reviewing complaints, reviewing production records, conducting annual product reviews, and approving or rejecting procedures, components, labeling, and drug products). During the inspection, you stated you did not consider your products to be animal drugs and therefore you did not establish any CGMP procedures. For the reasons discussed earlier in this letter, your products are animal drugs and are therefore subject to the CGMP requirement. A functioning quality unit with approval and rejection authority is a core element of CGMP.
2) Failure to test your drug products for conformance to final specifications. (21 CFR 211.165(a)).
No release testing was conducted on any animal drug products you manufactured and distributed. Testing each batch of drug products for conformance to specifications, including the identity and strength of each active ingredient, is important to ensure your drugs have the quantity of active ingredient you believe is needed to perform as you intend.
3) Failure to test your incoming components for identity, purity, strength, and other appropriate quality attributes. (21 CFR 211.84(d)).
You do not perform specific identity testing for each shipment of each lot of each component you receive and then test each component for conformity with all appropriate written specifications or otherwise establish the reliability of the supplier’s analyses.
The quality of the components you use has a direct effect on the quality of the drug products you manufacture, and testing incoming components for identity is an important step in preventing mislabeled components from being used in manufacturing.
Additionally, you do not have written procedures pertaining to incoming components or any associated records including, but not limited to: written procedures related to the receiving of containers, closures, and components; the rejection of nonconforming materials; or supplier qualifications/supplier quality agreements. You do not maintain copies of your supplier’s test results (i.e. Certificates of Analysis) for each raw material you use. You use raw materials from multiple outside suppliers.
4) Failure to establish written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. (21 CFR 211.67).
During the inspection, we observed visibly dirty equipment (e.g., your
(b)(4)
tank) that you use to manufacture your drug products.
You do not have any written procedures or records for the cleaning and maintenance of equipment that you use to make animal drugs. This includes, but is not limited to: written procedures for cleaning, equipment cleaning validation studies, clean/dirty hold time studies, and cleaning logs. You also do not have preventative maintenance procedures and maintenance logs.
Properly cleaned and maintained equipment is needed to prevent microbiological contamination or cross-contamination between batches of different drugs.
5) Failure to establish master production and control records for each drug product. (21 CFR 211.186(a)).
You do not have master production and control records for any of the drugs you produce. These documents are the foundation of manufacturing in compliance with CGMP because they describe and define each drug, its formulation, the containers, closures, and labeling to be used, the manufacturing process to be followed (the equipment and process), and the sampling and testing to be performed, among other things. As of the inspection, you did not have formulas for any of your products in writing or any master records of any type. These master records are a basic CGMP requirement and necessary to ensure consistency between batches of drug product.
6) Failure to prepare batch production and control records for each batch of drug product produced. (21 CFR 211.188).
You do not keep any written records (i.e., batch records) to document your manufacturing process.
Batch records are critical for a variety of reasons, such as facilitating review of the production process before batch release, performing investigations, and performing recalls. You have no records to establish what lots of what components were used, how much of each component was actually added, or what manufacturing processes were performed, and you would be unable to evaluate the need for a recall if, for example, there was a recall on a lot of one of the components you used.
In summary, you violate the FD&C Act’s CGMP requirement by:
- using untested components from suppliers you did not qualify; (
violation 3 above
)
- to manufacture drugs with no defined process or written formulation (i.e., no master production record); (
violation 5 above
)
- using equipment which we observed to be unclean during our inspection and for which you do not have cleaning procedures; (
violation 4 above
)
- without keeping any written records of what components or equipment you used (i.e., no batch records); (
violation 6 above
)
- without performing any tests to verify the quality of the finished product (e.g., identity and strength of active ingredient); (
violation 2 above
)
- and then released the drugs without the oversight of a quality unit, which should have rejected those drugs for the reasons above. (
violation 1 above
)
We have considered your response to the Form FDA 483. You acknowledged our concern about the absence of an adequately established quality unit and committed to the establishment of a dedicated QU by
(b)(4)
. However, your response failed to provide adequate detail and timelines regarding implementation. We are concerned that your complete lack of a quality unit has contributed–and continues to contribute–to a total failure of oversight regarding your CGMP operations. FDA has not received any recent updates from your firm regarding your proposed corrective actions. Additionally, your responses do not consider the need to mitigate any potential risks that may be associated with your CGMP-deficient processes in relation to your distributed products. During the inspection, you acknowledged the conditions cited above generally apply to all drugs you have manufactured since 2017.
CGMP Consultant Recommended
Based on the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and effectiveness of corrective actions and preventive actions. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. Our review indicates that you are offering for sale unapproved new animal drugs in addition to those listed above. If FDA takes legal action, the action may address all of your unapproved drugs, not just those listed above. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please direct your response to the U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 712860” in the subject line of your email.
Sincerely,
/S/
Cindy L. Burnsteel, DVM
Acting Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Cc: info@synergyanimalproducts.com
Content current as of:
09/02/2025
Regulated Product(s)
Animal & Veterinary