The internet has opened the door to many food operations to sell products. People often base their decision for purchasing based upon that website. Unfortunately, there is little more to go on than that. But is that enough? Recently, FDA inspected a Berkley California operation, Living Tree Community Foods, Inc. (https://www.livingtreecommunityfoods.com) and found that they were not producing foods to the required food safety standards.
Living Tree Community Foods, Inc, a Berkeley, CA processes organic seeds and tree nuts into ready to eat (RTE) organic seed and nut butters as well as repacks a variety of RTE and non RTE food products. The company had a Food Safety Plan, but was basically there for show in that it did not really address the hazards associated with the process. Company processes 25 different RTE nut & seed butters but "the hazard analysis did not identify biological, chemical, and physical hazards associated with these products and with tree nuts/seeds as significant hazards which require a preventive control at receiving, storage, slicing nuts and seeds, holding in bin, mixing (b)(4)/cooling, and/or packaging steps."
Allergen hazards - the hazard analysis in your “Food Safety Plan for Nut and Seed Butters, Muesli, Bars, and oils Version 2” did not consider the hazard of allergen cross contact as a potential food safety hazard at the slicing, or mixing steps to evaluate whether it requires a preventive control. The firm considered “allergen cross contamination” at the packaging/filling processing step; however, it was determined that that the hazard was not significant. Also did not identify and evaluate the hazard of undeclared allergens due to an incorrect label as a known or reasonably foreseeable hazard to determine whether it requires a preventive control.
Mycotoxins - in the hazard analysis for mycotoxins associated with the seeds and tree nuts as a potential food safety hazard to evaluate whether it requires a preventive control; the firm determined that the hazard was not significant based on ingredient and supplier history. Tree nuts and seeds are known to be associated with aflatoxins.
GMP issues - equipment and utensils were not designed and were not of such material and workmanship as to be adequately cleanable and were not adequately maintained to protect against contamination. The firm did not take reasonable precautions and measures to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) after each absence from the workstation and at any other time when hands may have become soiled or contaminated.
Labeling claims made on the labels were cited as well.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/living-tree-community-foods-inc-656541-03042024
Living Tree Community Foods, Inc.
MARCS-CMS 656541 — MARCH 04, 2024
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/living-tree-community-foods-inc-656541-03042024
Living Tree Community Foods, Inc.
MARCS-CMS 656541 — MARCH 04, 2024
Recipient:
Mr. Jesse Schwartz
President
Living Tree Community Foods, Inc.
1455 5th Street
Berkeley, CA 94710-1331
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
March 4, 2024
WL # 656541
Dear Mr. Schwartz:
The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 1455 5th Street, Berkeley, CA 94710, from February 13 through March 17, 2023, and we reviewed your labels and website, www.livingtreecommunityfoods.com, on October 11, 2023. Your firm manufactures organic seeds and tree nuts into ready to eat (RTE) organic seed and nut butters as well as repacks a variety of RTE and non RTE food products. During our inspection of your facility, the FDA investigators found serious violations of 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). At the conclusion of the inspection FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the RTE organic seed and tree nut butters that are processed and/or packaged in your facility 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 were 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 of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
Further, based on our inspection, subsequent review of product labeling collected during inspection, and review of your product labels for Sesame Tahini, Macadamia Butter, Milk of Paradise Cashew & Macadamia Butter, and Walnut Butter on your firm’s website, www.livingtreecommunityfoods.com, we have identified serious violations of the Act and applicable regulations, as discussed below.
You may find information relating to the CGMP & PC rule through links in FDA’s web page at https://www.fda.gov.
We received your written responses dated March 31 and April 28, 2023, which described a corrective action plan and included an unsigned revised Food Safety Plan Version 3/Hazard Analysis, new and updated procedures, receipts for purchases, photographs, and label inventory. Based on our review of the inspectional findings and the response that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We also address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. Your hazard analysis did not appropriately evaluate all known or reasonably foreseeable hazards to determine whether there are hazards requiring a preventive control for your RTE nut and seed butters, as required by 21 CFR 117.130(a)(1).
Specifically, your firm manufactures 25 different RTE nut & seed butters using a variety of tree nuts (almonds, Brazil nuts, pecans, walnuts, pine nuts, cashews, hazelnuts, pistachios, macadamia, and coconuts) and seeds (sesame seeds, pumpkin seeds, sunflower seeds, and hemp seeds). Your hazard analysis for “RTE Living Tree Community Foods alive & organic Walnut Butter, organic Milk of Paradise Cashew & Macadamia Butter, and alive & organic Sesame Tahini,” included in your “Food Safety Plan For Nut and Seed Butters, Muesli, Bars, and oils Version 2” dated March 21, 2020, did not identify biological, chemical, and physical hazards associated with these products and with tree nuts/seeds as significant hazards which require a preventive control at receiving, storage, slicing nuts and seeds, holding in bin, mixing (b)(4)/cooling, and/or packaging steps.
A. Your hazard analysis considered “Presence of pathogenic bacteria” associated with your seeds and tree nut ingredients at your receiving step, but you determined that the hazard was not significant. However, vegetative pathogens such as Salmonella have been associated with these tree nuts and seeds food products. Therefore, the pathogen of Salmonella is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify pathogens as a hazard requiring a preventive control in these ingredients. The hazard may be controlled during your processing or at your supplier. Your process does not apply a process preventative control such as a lethal treatment to any of your incoming raw materials and ingredients used in production of your RTE nut and seed butters. Your manager stated that all tree nuts and seeds used to manufacture your RTE nut and seed butter products are received raw, but only your almonds and cashews receive a treatment at the supplier to reduce pathogens.. You told our investigators that your firm did not identify pathogens (pathogenic E. coli and/or Salmonella) as a significant hazard requiring a preventive control for tree nuts and seeds because these hazards can be controlled by your existing prerequisite programs as listed in your hazard analysis. These prerequisite programs include “Approved Supplier Program,” “Good Manufacturing Practices” and “Receiving and Storage Practices.” However, these written programs did not have procedures in place to verify that the supplier is controlling pathogens that may be present in raw materials to mitigate the hazard.
You maintain an “Approved Supplier Program” whereby you request the supplier to complete an “Approved Supplier Questionnaire” (b)(4) and (b)(4), thereafter. Your 2022 Supplier List showed you have (b)(4) approved suppliers; however, you only have completed questionnaires for 3 current suppliers and 1 previous supplier. Furthermore, you have only signed off on 1 of the 4 completed questionnaires as approved by your firm. The other 3 questionnaires did not include an approval decision. Further, the “Approved Supplier Questionnaire” asks about Food Safety Plans and 3rd party audits, but you do not review the 3rd party audit reports or verify supplier controls through an onsite audit.
Because you rely on your suppliers to control these hazards, the appropriate type of control is a supply-chain control. A facility that identifies raw materials and other ingredients with hazards such as Salmonella and E. coli that require a supply-chain-applied control must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting adequate supplier verification activities (see 21 CFR 117.410). Vegetative pathogens such as Salmonella in RTE tree nut and seed butters are hazards that can cause serious adverse health consequences or death. Therefore, an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter (see 21 CFR 117.430(b)(1)(ii)).
You provided an updated “Food Safety Plan For Nut and Seed Butters, Muesli, Bars, and oils Version 3,” which included a revised hazard analysis. The hazard analysis identifies Salmonella and E. coli as pathogen hazards in seeds and tree nuts. You identified “Preventive Control #1 – Approved Supplier Program which includes Continuing Letters of Guarantee and Specifications” at the Receiving Step as the control that will be applied to ensure only approved materials are received. In your response dated April 28, 2023, you provided a revised “Approved Supplier Program Version 3.” Your responses did not indicate what requirements the supplier must meet to demonstrate control of the pathogen hazards. Further, you did not address how you will manage current suppliers without appropriate controls in place to mitigate a pathogen hazard. For example, your current sesame seed supplier labels their product as not processed to control for pathogens.
B. Your hazard analysis in your “Food Safety Plan for Nut and Seed Butters, Muesli, Bars, and oils Version 2” did not consider the hazard of allergen cross contact as a potential food safety hazard at your slicing, or mixing steps to evaluate whether it requires a preventive control. Your firm considered “allergen cross contamination” at the packaging/filling processing step; however, you determined that the hazard was not significant. Your firm manufactures nut and seed butters using shared equipment on the same day. Your shared equipment includes the (b)(4) slicing machine at the slicing step, the (b)(4) machines at the mixing step, and the jar filling machine at packaging. You identified prerequisite programs of “Allergen Control Program”, “Cleaning Program”, and “Good Manufacturing Practices” at these steps; however, they do not include monitoring, corrective actions, verification procedures and recordkeeping to ensure allergen cross-contact controls are implemented within your facility. Furthermore, you do not have adequate controls in place as evidenced by the following:
a. On February 16,2023, our investigators observed a significant amount of food debris and black residue on the food contact surfaces of the cleaned and ready-to-use (b)(4) slicing machine in areas such as where the slicing head sits, underneath the belt cover and on the back leg. This machine is used to slice sesame seeds, almonds, pistachios, pecans, and walnuts. The machine was last used on February 14, 2023 to slice walnuts, and your “(b)(4) Housekeeping Schedule” dated February 14, 2023 indicated that the slicer was cleaned after use, and it was verified cleaned by your manager.
b. On March 8, 2023, our investigators observed food residue build-up on the area where the slicing head sits while your employee was using the same (b)(4) to slice sesame seeds. The food residue appeared to be residue from previous use. Your manager identified the product run on the machine as almonds from the week of February 27, 2023. Further, your manager stated you do not remove this section of the machine during cleaning.
c. On March 8, 2023 FDA collected a sample of your Walnut Butter, lot (b)(4). One sub-sample was analyzed using both the (b)(4) and the (b)(4). This subsample displayed response characteristics of 7 and 9ppm (in (b)(4)), and 5 ppm sesame according to the (b)(4), and the (b)(4), respectively. Your firm sliced sesame seeds on your (b)(4) machine from February 2, 2023 until February 08, 2023. You cleaned your (b)(4) machine on February 8, 2023, and then used the machine to slice the walnuts on February 9, 2023, which were used in Walnut Butter, lot, (b)(4). These findings indicate that you did not adequately clean your (b)(4) machine to prevent sesame from being present in your Walnut Butter.
Your response dated March 31, 2023, provided an updated “Food Safety Plan For Nut and Seed Butters, Muesli, Bars, and oils Version 3,” which included a revised hazard analysis. The hazard analysis identifies allergen cross contact as a hazard at the following process steps: slicing, holding in bin, mixing and packaging and indicates “Preventive Control (b)(4) - Cleaning Program, Cleaning Schedules, Processing Log” as the preventive control to mitigate this hazard. In your response dated April 28, 2023, you provided an updated “Cleaning Program Version 2” and “Allergen Control Program Version 2.” The Cleaning Program and Allergen Control Program include a verification activity of using (b)(4). Your responses do not include documentation, such as completed monitoring records, showing that you have implemented your allergen cross-contact controls. (b)(5).
C. You did not identify and evaluate the hazard of undeclared allergens due to an incorrect label as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. A knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for labeling to ensure that all food allergens that are present in the food are included on the label (see 21 CFR 117.135(c)(2)(ii)). We note that your pre-requisite “Allergen Control Program” stated that your firm will control undeclared allergens through (b)(4). However, it does not include monitoring, corrective actions, and verifications procedures to control undeclared allergens. Further, your firm does not keep records of label review.
Your responses provided an updated “Food Safety Plan For Nut and Seed Butters, Muesli, Bars, and oils Version 3,” which included a revised hazard analysis and a revised “Allergen Control Program Version 2”. The hazard analysis identifies allergen mislabeling as a hazard at the packaging step. Your responses do not include documentation, such as completed monitoring records, showing that you have implemented your allergen cross-contact controls. (b)(5).
D. Your hazard analysis included in your “Food Safety Plan for Nut and Seed Butters, Muesli, Bars, and oils Version 2” considered mycotoxins associated with your seeds and tree nuts as a potential food safety hazard to evaluate whether it requires a preventive control; however, you determined that the hazard was not significant based on ingredient and supplier history. Tree nuts and seeds are known to be associated with aflatoxins. Therefore, contamination with mycotoxins is a known or reasonable foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients.
We note that you have not established a preventive control within your facility to address mycotoxins. Therefore, you are required to establish and implement a supply-chain program covering mycotoxins in ingredients used to make your nuts and seed butters, to comply with 21 CFR 117.405(a)(1). You identified prerequisite programs such as “Approved Supplier Program” and “Receiving and Storage Practices” as programs in place to reduce chemical hazards. However, these programs did not indicate what procedures your firm has established to control mycotoxins, nor address verification activities or corrective actions. Moreover, you only receive certificates of analysis (COAs) for raw almonds, sesame seeds, and cashews, and they are not reviewed for mycotoxins.
Your response dated March 31, 2023, stated that you reviewed and revised your risk analysis for all raw materials and process steps for all chemical hazards. Your revised hazard analysis for tree nuts does not identify mycotoxins as a significant hazard and states “[n]ot expected to occur, ingredient history indicates no instances of chemical contamination.” However, we note mycotoxins are identified as a potential hazard at the receiving step and “Preventive Control (b)(4) – Approved Supplier Program which includes Continuing Letters of Guarantee and Specifications” is identified as the preventive control. The procedure for this preventive control identifies criteria of “monitoring, raw material specifications state all materials are below legal limits for mycotoxins or other natural toxins.” The verification activity does not ensure that each lot received is below allowable limits.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. Your equipment and utensils were not designed and were not of such material and workmanship as to be adequately cleanable and were not adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1). Specifically,
On February 16, 2023, our investigators observed an approximately inch long cut on the food contact surface of the (b)(4) mixer bowl. This mixer is one of the (b)(4) mixers used in mixing your RTE nut and seed butters.
On February 16, 2023, our investigators observed a large section of an off-white-colored lid gasket on one of the (b)(4) mixer bowls with signs of wear and tear; these areas appeared to be blackened through accumulation of food residue over time.
Your response stated that the mixing bowl will be repaired or replaced by (b)(4), and that it has been taken out of service. Further, you provided a photograph and receipt for the purchase of one lid gasket; however, you did not explain how you will prevent reoccurrence. (b)(5).
2. You did not take reasonable precautions and measures to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) after each absence from the workstation and at any other time when hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3). Specifically, on March 8, 2023, our investigator observed an employee at the (b)(4) machine removing one of the gloves he was wearing and throwing it into the trash bin by lifting the dirty trash can lid with his barehand. The employee did not wash his hands prior to donning new gloves. The employee continued to open sesame seed bags and pour them into (b)(4). Then he took these (b)(4) to the (b)(4) to pour the sesame into the machine. Later in the (b)(4), the same employee touched the same trash can lid with cleaned hands as he was throwing away the paper towel he used to dry his hands after washing them. He then donned a new pair of gloves without re-washing his hands and continued to complete his work at the (b)(4). Following both instances, our investigator observed the employee’s gloved hands touching the inside of the (b)(4). These (b)(4) are re-used for storing the sesame meal afterwards with no further cleaning.
Your response dated April 28, 2023, provided a revised “Good Manufacturing Practices Version 3” procedure which defines glove use, when gloves must be changed, and requires washing hands before donning a new pair of gloves. (b)(5).
Unapproved New Drugs and Misbranded Drugs
We reviewed your website where you take orders for your product Sesame Tahini in October 2023. The webpage: https://www.livingtreecommunityfoods.com/product/tahini-alive-and-organic?v=3 has a link to the webpage https://www.naturalnews.com/026409_tahini_calcium_cancer.html.
The claims on your websites establish this product is a drug 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 product is intended for use as a drug include:
- “Tahini contains B vitamins...” “recent studies have also shown that vitamin B can help protect against one of the most deadly forms of cancer, pancreatic cancer, but only when consumed in food it is because of this that you will now find tahini for sale in most health shops.”
- “[H]igher total calcium intake is associated with a decreased risk of digestive system cancers ... findings show that high calcium intake was associated with a reduced overall cancer risk especially amongst women. This is where tahini can come in as just 35 grms [sic] of tahini can contain almost 35% of your recommended daily calcium intake.”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 product Sesame Tahini is intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, the product Sesame Tahini fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Misbranded Foods
1. Your Sesame Tahini, Walnut Butter, Macadamia Butter and Milk of Paradise Cashew & Macadamia Butter products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not comply with the requirements of 21 CFR 101.9. For example, the nutrients declared in the nutrition label are not in accordance with 21 CFR 101.9(c), and the format is not in accordance with 21 CFR 101.9(d). In addition,
o Your Walnut Butter label bears nutrient content claims for various nutrients such as fatty acids, protein, phosphorus, vitamin B, and vitamin D. However, the Nutrition Facts label fails to meet the requirements in 21 CFR 101.9(c)(8)(ii), 21 CFR 101.9(c)(7)(i), and 21 CFR 101.9(c)(2)(iii) and (iv) which include declaring phosphorus, vitamin B, and vitamin D, the percent daily value of protein, and polyunsaturated and monounsaturated fat respectively.
o Your Sesame Tahini website labeling bears the claim “source of zinc.” However, the Nutrition Facts labels fails to declare zinc as required by 21 CFR 101.9(c)(8)(ii).Your Macadamia Butter and Milk of Paradise Cashew & Macadamia Butter products bear a nutrient content claim for protein. However, the Nutrition Facts labels fail to include the percent daily value of protein as required by 21 CFR 101.9(c)(7)(i).
2. Your Macadamia Butter, Milk of Paradise Cashew & Macadamia Butter, and Walnut Butter products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims but do not meet the requirements to make the claims. In addition, even if your Sesame Tahini product was not an unapproved new drug and misbranded drug, it is misbranded within the meaning of section 403(r)(1)(A) of the Act.
a. The Walnut Butter label claim “Walnuts are an excellent source of antioxidants” does not indicate the names of the nutrients that are the subject of the claim or link the nutrients with the claim by use of a symbol as required by 21 CFR 101.54(g)(4). The use of a nutrient content claim that uses the term “antioxidant” but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(1)(A) of the Act.
b. The Walnut Butter label claims “They [walnuts] are significantly higher than any other nut in omega-3 essential fatty acids”. The statement is an unauthorized nutrient content claim because there is no established daily value for omega-3 fatty acids. A claim for Omega-3 does not meet requirements for nutrient content claims for ALA, DHA, and EPA omega-3 fatty acids which have been statutorily authorized through the notification procedure in section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)].
c. The Sesame Tahini and Macadamia Butter labels bear the claims “No oil added,” and “no . . . sugar . . . .” but do not meet the requirements to bear these claims in 21 CFR 101.65(c)(3) and 21 CFR 101.60(c)(1), respectively. Specifically, the foods do not meet the definition of fat free; and “no . . . sugar” is not immediately accompanied, each time it is used, by either the statement "not a reduced calorie food," "not a low calorie food," or "not for weight control."
d. The Macadamia Butter, Milk of Paradise Cashew & Macadamia Butter, and Walnut Butter products bear a “High in Protein” claim on the products’ corresponding webpage at the firm’s website, www.livingtreecommunityfoods.com, but they do not meet the requirement for “high” in 21 CFR 101.54(b).
We acknowledge your written response in which you stated you will review and revise your product labels, specifically, that you will develop new nutrition facts to be in compliance with food labeling regulations. You estimated revisions will be completed by (b)(4). We reminded you that manufacturers with less than $10 million in annual food sales had a compliance date of January 1, 2021.
This letter is not intended to be an all-inclusive list of the 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 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.
Additional Comments Pertaining to Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
Your revised hazard analysis identified “Introduction of Pathogenic Bacteria from people or equipment” as a hazard at the following process steps: slicing, hold in bin, mixing and packaging. You identified “Preventive Control (b)(4) - Cleaning Program, Cleaning Schedules, Processing Log” as the preventive control to mitigate the hazard at the corresponding process steps. You also provided a revised “Cleaning Program version 2” and other cleaning procedures. We note that your “Cleaning Program version 2” indicates that you will verify cleaning effectiveness with (b)(4) Salmonella and Listeria environmental monitoring following your “Environmental Monitoring Program.” However, your response did not provide your “Environmental Monitoring Program” procedure or evidence of its implementation such as environmental monitoring results.
Furthermore, on February 16, 2023, our investigator observed that an employee did not sanitize the disassembled parts of a (b)(4) machine such as the lid gasket and the mixer blade after they were cleaned in the 2-compartment sink. Your responses provided updated cleaning procedures and stated that employees will be trained to the new procedure. (b)(5).
As you work to address the violations cited in this Warning Letter, we remind you that preventive controls, such as sanitation controls, are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)).
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps 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 actions 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.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number CMS# 639559 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5
Your response dated March 31, 2023, stated that you reviewed and revised your risk analysis for all raw materials and process steps for all chemical hazards. Your revised hazard analysis for tree nuts does not identify mycotoxins as a significant hazard and states “[n]ot expected to occur, ingredient history indicates no instances of chemical contamination.” However, we note mycotoxins are identified as a potential hazard at the receiving step and “Preventive Control (b)(4) – Approved Supplier Program which includes Continuing Letters of Guarantee and Specifications” is identified as the preventive control. The procedure for this preventive control identifies criteria of “monitoring, raw material specifications state all materials are below legal limits for mycotoxins or other natural toxins.” The verification activity does not ensure that each lot received is below allowable limits.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. Your equipment and utensils were not designed and were not of such material and workmanship as to be adequately cleanable and were not adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1). Specifically,
On February 16, 2023, our investigators observed an approximately inch long cut on the food contact surface of the (b)(4) mixer bowl. This mixer is one of the (b)(4) mixers used in mixing your RTE nut and seed butters.
On February 16, 2023, our investigators observed a large section of an off-white-colored lid gasket on one of the (b)(4) mixer bowls with signs of wear and tear; these areas appeared to be blackened through accumulation of food residue over time.
Your response stated that the mixing bowl will be repaired or replaced by (b)(4), and that it has been taken out of service. Further, you provided a photograph and receipt for the purchase of one lid gasket; however, you did not explain how you will prevent reoccurrence. (b)(5).
2. You did not take reasonable precautions and measures to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) after each absence from the workstation and at any other time when hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3). Specifically, on March 8, 2023, our investigator observed an employee at the (b)(4) machine removing one of the gloves he was wearing and throwing it into the trash bin by lifting the dirty trash can lid with his barehand. The employee did not wash his hands prior to donning new gloves. The employee continued to open sesame seed bags and pour them into (b)(4). Then he took these (b)(4) to the (b)(4) to pour the sesame into the machine. Later in the (b)(4), the same employee touched the same trash can lid with cleaned hands as he was throwing away the paper towel he used to dry his hands after washing them. He then donned a new pair of gloves without re-washing his hands and continued to complete his work at the (b)(4). Following both instances, our investigator observed the employee’s gloved hands touching the inside of the (b)(4). These (b)(4) are re-used for storing the sesame meal afterwards with no further cleaning.
Your response dated April 28, 2023, provided a revised “Good Manufacturing Practices Version 3” procedure which defines glove use, when gloves must be changed, and requires washing hands before donning a new pair of gloves. (b)(5).
Unapproved New Drugs and Misbranded Drugs
We reviewed your website where you take orders for your product Sesame Tahini in October 2023. The webpage: https://www.livingtreecommunityfoods.com/product/tahini-alive-and-organic?v=3 has a link to the webpage https://www.naturalnews.com/026409_tahini_calcium_cancer.html.
The claims on your websites establish this product is a drug 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 product is intended for use as a drug include:
- “Tahini contains B vitamins...” “recent studies have also shown that vitamin B can help protect against one of the most deadly forms of cancer, pancreatic cancer, but only when consumed in food it is because of this that you will now find tahini for sale in most health shops.”
- “[H]igher total calcium intake is associated with a decreased risk of digestive system cancers ... findings show that high calcium intake was associated with a reduced overall cancer risk especially amongst women. This is where tahini can come in as just 35 grms [sic] of tahini can contain almost 35% of your recommended daily calcium intake.”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 product Sesame Tahini is intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, the product Sesame Tahini fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Misbranded Foods
1. Your Sesame Tahini, Walnut Butter, Macadamia Butter and Milk of Paradise Cashew & Macadamia Butter products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not comply with the requirements of 21 CFR 101.9. For example, the nutrients declared in the nutrition label are not in accordance with 21 CFR 101.9(c), and the format is not in accordance with 21 CFR 101.9(d). In addition,
o Your Walnut Butter label bears nutrient content claims for various nutrients such as fatty acids, protein, phosphorus, vitamin B, and vitamin D. However, the Nutrition Facts label fails to meet the requirements in 21 CFR 101.9(c)(8)(ii), 21 CFR 101.9(c)(7)(i), and 21 CFR 101.9(c)(2)(iii) and (iv) which include declaring phosphorus, vitamin B, and vitamin D, the percent daily value of protein, and polyunsaturated and monounsaturated fat respectively.
o Your Sesame Tahini website labeling bears the claim “source of zinc.” However, the Nutrition Facts labels fails to declare zinc as required by 21 CFR 101.9(c)(8)(ii).Your Macadamia Butter and Milk of Paradise Cashew & Macadamia Butter products bear a nutrient content claim for protein. However, the Nutrition Facts labels fail to include the percent daily value of protein as required by 21 CFR 101.9(c)(7)(i).
2. Your Macadamia Butter, Milk of Paradise Cashew & Macadamia Butter, and Walnut Butter products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims but do not meet the requirements to make the claims. In addition, even if your Sesame Tahini product was not an unapproved new drug and misbranded drug, it is misbranded within the meaning of section 403(r)(1)(A) of the Act.
a. The Walnut Butter label claim “Walnuts are an excellent source of antioxidants” does not indicate the names of the nutrients that are the subject of the claim or link the nutrients with the claim by use of a symbol as required by 21 CFR 101.54(g)(4). The use of a nutrient content claim that uses the term “antioxidant” but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(1)(A) of the Act.
b. The Walnut Butter label claims “They [walnuts] are significantly higher than any other nut in omega-3 essential fatty acids”. The statement is an unauthorized nutrient content claim because there is no established daily value for omega-3 fatty acids. A claim for Omega-3 does not meet requirements for nutrient content claims for ALA, DHA, and EPA omega-3 fatty acids which have been statutorily authorized through the notification procedure in section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)].
c. The Sesame Tahini and Macadamia Butter labels bear the claims “No oil added,” and “no . . . sugar . . . .” but do not meet the requirements to bear these claims in 21 CFR 101.65(c)(3) and 21 CFR 101.60(c)(1), respectively. Specifically, the foods do not meet the definition of fat free; and “no . . . sugar” is not immediately accompanied, each time it is used, by either the statement "not a reduced calorie food," "not a low calorie food," or "not for weight control."
d. The Macadamia Butter, Milk of Paradise Cashew & Macadamia Butter, and Walnut Butter products bear a “High in Protein” claim on the products’ corresponding webpage at the firm’s website, www.livingtreecommunityfoods.com, but they do not meet the requirement for “high” in 21 CFR 101.54(b).
We acknowledge your written response in which you stated you will review and revise your product labels, specifically, that you will develop new nutrition facts to be in compliance with food labeling regulations. You estimated revisions will be completed by (b)(4). We reminded you that manufacturers with less than $10 million in annual food sales had a compliance date of January 1, 2021.
This letter is not intended to be an all-inclusive list of the 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 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.
Additional Comments Pertaining to Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
Your revised hazard analysis identified “Introduction of Pathogenic Bacteria from people or equipment” as a hazard at the following process steps: slicing, hold in bin, mixing and packaging. You identified “Preventive Control (b)(4) - Cleaning Program, Cleaning Schedules, Processing Log” as the preventive control to mitigate the hazard at the corresponding process steps. You also provided a revised “Cleaning Program version 2” and other cleaning procedures. We note that your “Cleaning Program version 2” indicates that you will verify cleaning effectiveness with (b)(4) Salmonella and Listeria environmental monitoring following your “Environmental Monitoring Program.” However, your response did not provide your “Environmental Monitoring Program” procedure or evidence of its implementation such as environmental monitoring results.
Furthermore, on February 16, 2023, our investigator observed that an employee did not sanitize the disassembled parts of a (b)(4) machine such as the lid gasket and the mixer blade after they were cleaned in the 2-compartment sink. Your responses provided updated cleaning procedures and stated that employees will be trained to the new procedure. (b)(5).
As you work to address the violations cited in this Warning Letter, we remind you that preventive controls, such as sanitation controls, are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)).
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps 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 actions 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.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number CMS# 639559 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5
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