Sprout company warned about pathogen contamination, drug claims

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Sunny Creek Farm Inc.
Tryon, NC

A food firm in North Carolina is on notice from the FDA for serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation.

In a Feb. 2 warning letter, the FDA described an Aug.10-20, 2021 inspection of Sunny Creek Farm Inc.’s sprouting operation in Tryon, NC.

The FDA’s inspection revealed that the firm was not in compliance the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation and resulted in the issuance of an FDA Form 483. 

Based on inspectional findings, the FDA has determined that the firm’s alfalfa, broccoli, and clover sprout products, and any combinations thereof are adulterated.

FDA investigators observed the some of the following violations of the Produce Safety Rule:

1. The firm did not discontinue the use of all seeds from a lot that they knew or had reason to believe may have been contaminated with a pathogen, and they did not ensure that sprouts grown from that lot of seeds did not enter commerce. Specifically, when spent sprout irrigation water (SSIW) samples corresponding to specific seed lots tested positive for pathogens, they did not discontinue the use of seeds from those lots. They also did not perform either of the actions that would have negated the requirement to discontinue use of the seeds, i.e., they 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, and they did not demonstrate any reasonable determination, through appropriate follow-up actions, that the lot of seeds was not the source of contamination. An FDA investigator documented the following:

• At least (redacted) batches of clover sprouts from seed lot (redacted) were distributed into commerce after a sample of SSIW corresponding to that lot, collected (redacted), tested positive for E. coli O157:H7.
• At least (redacted) batches of broccoli sprouts from seed lot (redacted) were distributed into commerce after a sample of SSIW corresponding to that lot, collected (redacted), tested positive for E. coli O157:H7.
• At least (redacted) batches of alfalfa sprouts from seed lot (redacted) were distributed into commerce after a sample of SSIW corresponding to that lot, collected on (redacted), tested positive for Salmonella.
• At least (redacted) batches of alfalfa sprouts from seed lot (redacted) were distributed into commerce after a sample of SSIW corresponding to that lot, collected on (redacted), tested positive for Salmonella.

Furthermore, when the SSIW samples tested positive for pathogens, it was not clear that they had reported the findings of microbial testing to the supplier of those seeds as required. Specifically, during FDA’s inspection, the firm indicated that they did not have any documentation of having notified the supplier. Additionally, their Standard Operating Procedure (SOP) titled SOP14 61417 – “(redacted)” was reviewed by FDA investigators. The corrective action procedures in their SOP do not detail when and how they 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.

2. The firm did not clean and sanitize their food contact surfaces used to grow, harvest, pack, or hold sprouts before contact with seeds or beans used to grow sprouts, as required. They use (redacted) to hold seeds and beans during seed treatment. Their 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 their 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 their mung bean sprouts are spun in this piece of equipment prior to packaging.

3. The firm’s 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. The firm’s 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.

4. The firm’s 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. FDA investigators documented their employee training, agricultural water, and environmental monitoring records did not indicate that they had been reviewed, dated, and signed. The FDA also noted that this is a repeat observation from their previous inspection conducted in March 2018.

Unapproved New Drugs/Misbranded:
In addition, FDA reviewed the website listed on their Broccoli Sprouts, Deli Blend, and Salad Blend product labels at the internet address, www.sunnycreekfarm.com, in November 2021. The claims on their 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 their 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 the firm’s 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.”

The firm’s 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)]. 

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.

The firm’s products, Broccoli Sprouts, Deli Blend, and Salad Blend, are intended for the 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 their product safely for its intended purposes. Accordingly, their 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)].

The full warning letter can be viewed here.

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