- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameLee G. Ewing
Recipient TitlePresident and Owner
- Sunny Creek Farm, Inc.
520 Pinefield Drive
Tryon, NC 28782-7795
- Issuing Office:
- Division of Human and Animal Food Operations East III
February 2, 2022
Reference: CMS Case 617664
Dear Mr. Ewing:
The U.S. Food and Drug Administration (FDA) inspected your sprouting operation located at 520 Pinefield, Drive, Tryon, NC, 28782 from August 10, 2021, through August 20, 2021. Our inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety Regulation or PSR), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112). Your operation is a farm mixed-type facility because your sprout growing operation is a farm, and you also conduct activities outside of the farm definition (i.e., storage of certain other food) that requires registration (see definitions of “facility,” “farm,” and “mixed-type facility” in 21 CFR 1.227). Your farm is subject to Part 112 and your facility is subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on our inspectional findings, we have determined that your alfalfa, broccoli, and clover sprout products, and any combinations thereof are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the PSR is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)]. You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
The inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations, listing the violations found at your sprouting operation during our inspection. We acknowledge receipt of your response dated September 10, 2021, to the FDA-483, which included corrective actions you have implemented or plan to implement. We address your response below.
Additionally, FDA reviewed your website at the Internet address www.sunnycreekfarm.com in November 2021. The claims on your website concerning your broccoli sprouts establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Produce Safety Rule Violations
During the inspection, FDA investigators observed the following significant violations of the PSR, 21 CFR Part 112:
1. You did not discontinue the use of all seeds from a lot which you knew or had reason to believe may have been contaminated with a pathogen, and you did not ensure that sprouts grown from that lot of seeds did not enter commerce as required by 21 CFR 112.142(b)(1). Specifically, when spent sprout irrigation water (SSIW) samples corresponding to specific seed lots tested positive for pathogens, you did not discontinue the use of seeds from those lots. You also did not perform either of the actions that would have negated the requirement to discontinue use of the seeds, i.e., you did not treat the seeds with a process reasonably certain to achieve destruction or elimination of the most resistant microorganisms of public health significance likely to occur in the seeds, per 21 CFR 112.142(c)(1); and you did not demonstrate any reasonable determination, through appropriate follow-up actions, that the lot of seeds was not the source of contamination, per 21 CFR 112.142(c)(2). Our investigator documented the following:
- At least (b)(4) batches of clover sprouts from seed lot (b)(4) were distributed into commerce after a sample of SSIW corresponding to that lot, collected (b)(4), tested positive for E. coli O157:H7.
- At least (b)(4) batches of broccoli sprouts from seed lot (b)(4) were distributed into commerce after a sample of SSIW corresponding to that lot, collected (b)(4), tested positive for E. coli O157:H7.
- At least than (b)(4) batches of alfalfa sprouts from seed lot (b)(4) were distributed into commerce after a sample of SSIW corresponding to that lot, collected on (b)(4), tested positive for Salmonella.
- At least (b)(4) batches of alfalfa sprouts from seed lot (b)(4) were distributed into commerce after a sample of SSIW corresponding to that lot, collected on (b)(4), tested positive for Salmonella.
Furthermore, when the SSIW samples tested positive for pathogens, it was not clear that you had reported the findings of microbial testing to the supplier of those seeds as required by 21 CFR 112.142(b)(2). Specifically, during FDA’s inspection, you indicated that you did not have any documentation of having notified the supplier. Additionally, your Standard Operating Procedure (SOP) titled SOP14 61417 – “(b)(4)” was reviewed by our investigators. The corrective action procedures in your SOP do not detail when and how you will discontinue the use of seed lots or notify the suppliers of such lots if a sample of SSIW associated with a particular lot tests positive for an applicable pathogen as required by 21 CFR 112.147(c).
Your response dated September 10, 2021, includes an updated procedure that states you will place a hold on seeds when a sample of SSIW tests positive for pathogens and you will notify your supplier of the positive test results. However, this response fails to detail when and how you will discontinue the use of seed lots or notify the supplier of such lots if a sample of SSIW associated with a particular lot tests positive for an applicable pathogen as required by 21 CFR 112.14(c).
2. You did not clean and sanitize your food contact surfaces used to grow, harvest, pack, or hold sprouts before contact with seeds or beans used to grow sprouts, as required by 21 CFR 112.143(b)). You use (b)(4) to hold seeds and beans during seed treatment. Your General Manager stated that after treatment the bags are rinsed and reused with no additional cleaning or sanitization performed prior to further contact with seeds or beans.
Additionally, investigators observed a red residue on the inside of the lid of the green sprout spinner. Pieces of sprouts were observed in direct contact with the residue. All of your green sprouts are spun in this piece of equipment prior to packaging.
Finally, the gasket on the inside of the mung bean spinner lid appeared worn and unsmooth, rendering it difficult to clean. All of your mung bean sprouts are spun in this piece of equipment prior to packaging.
Your response dated September 10, 2021, states that you have purchased (b)(4) and will now use the (b)(4) instead of the (b)(4). However, your response does not include enough details regarding the use and cleaning of the (b)(4). Therefore, we cannot evaluate the adequacy of this correction. Additionally, your firm appears to address the specific issues noted by our investigator concerning the green sprout spinner and the mung bean spinner. However, your response does not include procedures you plan to take in order to prevent these violations from recurring. We will verify the adequacy of your corrections during our next inspection.
3. Your environmental monitoring plan did not specify sample collection sites including appropriate food contact and non-food contact surfaces of equipment, and other surfaces within the growing, harvesting, packing, and holding environment, as required by 21 CFR 112.145(c)(3). Your HACCP Manager stated that swab locations are determined at random, and the time of sampling varies and may include times when production is not occurring.
Your response dated September 10, 2021, does not include any specific sample collection sites. Although your environmental monitoring plan references an “Environmental Sampling Plan Log,” you have not included a copy of this log with your response. Additionally, your response includes corrective actions your firm will take for an environmental swab for Listeria monocytogenes on a non-food contact surface, but it does not include corrective action you plan to take for positive swabs on food contact surfaces.
4. Your required records were not reviewed, dated, and signed by a supervisor or responsible party within a reasonable time after the records were made as required by 21 CFR 112.161(b). Our investigator documented your employee training, agricultural water, and environmental monitoring records did not indicate that they had been reviewed, dated, and signed. We also note that this is a repeat observation from our previous inspection conducted in March 2018.
Your response dated September 10, 2021, states that with respect to failure to date and sign records, “…steps have been put in place to prevent this from happening again.” However, your response does not include a description of the referenced steps. Therefore, an inspection will be necessary to evaluate the adequacy and implementation of this corrective action.
Unapproved New Drugs/Misbranded
In addition, FDA reviewed the website listed on your Broccoli Sprouts, Deli Blend, and Salad Blend product labels at the internet address, www.sunnycreekfarm.com, in November 2021. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction, into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
FAQ page, “Why Broccoli Sprouts”:
• “Cruciferous vegetables, including broccoli, and in particular broccoli sprouts, have thus been hypothesized to play a role in the amelioration of gastritis, peptic ulcer disease, and stomach cancer as well as a variety of oxidative and degenerative conditions. This includes cancers, at a variety of organ sites, as well as working to repair age-related macular degeneration, and hypertension.”
• “One of the best chemoprotective nutrients from cruciferous vegetables that prevents the…growth of tumors is sulforaphane… Broccoli sprouts are one of the best foods for the bioavailability of sulforaphane.”
Sprout Science page:
• “8 Nutrients That Block Cancer Metastasis… Eat to starve cancer by feeding your body the 8 nutrients listed below to stimulate apoptosis in cancer cells, prevent angiogenesis and consequently inhibit tumor formation and cancer metastasis to other areas of the body... 5. Sulforaphane It is found in broccoli sprouts and other cruciferous vegetables like cauliflower, broccoli, brussels sprouts, and kale.”
• “Broccoli Sprouts… How the epigenetic benefits of eating broccoli sprouts overcame my genetics and saved my life from cancer, heart disease and Alzheimer’s.”
o This claim is followed by an approximately 17-minute video testimonial by your CEO, Edward Mills, in which he discusses how consuming broccoli sprouts saved his life from cancer, heart disease, and Alzheimer’s.
o Additional claims made in the video include:
At 3:49: “An important aspect of the compound [sulforaphane] is that it crosses the blood brain barrier and protects against neurodegenerative diseases; it also protects against cardiovascular disease and helps fight cancer.”
At 7:16: “Interestingly, several studies involving children with autism and sulforaphane also were shown to reduce symptoms by 26%. Another study with people who have symptoms of schizophrenia… their symptoms were reduced by 25%.”
At 9:52: “…here’s what I think how eating broccoli sprouts all these years has prevented me from having Alzheimer’s…”
At 11:50: “As I stated before, broccoli sprouts have antiviral, antibacterial, antifungal properties that fight the infections that cross the blood brain barrier.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products, Broccoli Sprouts, Deli Blend, and Salad Blend, are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your Broccoli Sprouts, Deli Blend, and Salad Blend fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist 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 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 adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address 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 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your written response to the attention of Stephen J. Rabe, Compliance Officer at: firstname.lastname@example.org and Stephen.email@example.com or:
U.S. Food and Drug Administration
Attn: Stephen J. Rabe, Compliance Officer
6751 Steger Drive
Cincinnati, OH 45237
Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3
Anita MacMullan, Director
North Carolina Department of Agriculture and Consumer Services
4400 Reedy Creek Road
Raleigh, NC 27607