What changed in this filing

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Item 1. Business

2023-08-24 compared with 2022-08-25 · 51 added, 113 removed, 170 unchanged (49% of the section changed)

The Hain Celestial Group, Inc., a Delaware corporation (collectively, along with its subsidiaries, the “Company,” and herein referred to as “Hain Celestial,” “we,” “us” and “our”), was founded in 1993 and is headquartered in Lake Success, New York.

The Company’s mission has continued to evolve since its founding, with health and wellness being the core tenet.

The Company continues to be a leading marketer, manufacturer and seller of organic and natural, “better-for-you” products by anticipating and exceeding consumer expectations in providing quality, innovation, value and convenience.

The Company is a leading manufacturer, marketer and seller of better-for-you brands that inspire healthier living.

The Company is committed to growing sustainably while continuing to implement environmentally sound business practices and manufacturing processes.

Hain Celestial sells its products through specialty and natural food distributors, supermarkets, natural food stores, mass-market and e-commerce retailers, food service channels and club, drug and convenience stores in over 75 countries worldwide.

The Company manufactures, markets, distributes and sells organic and natural products providing consumers with the opportunity to lead A Healthier Way of Life ® .

The Company’s food and beverage brands include Celestial Seasonings ® , Clarks ™ , Cully & Sully ® , Earth’s Best ® , Ella’s Kitchen ® , Frank Cooper’s ® , Garden of Eatin’ ® , Hartley’s ® , Health Valley ® , Imagine ® , Joya ® , Lima ® , Linda McCartney’s ® (under license), MaraNatha ® , Natumi ® , New Covent Garden Soup Co.

® , ParmCrisps ® , Robertson’s ® , Rose’s ® (under license), Sensible Portions ® , Spectrum ® , Sun-Pat ® , Terr a ® , The Greek Gods ® , Thinsters ® , Yorkshire Provender ® and Yves Veggie Cuisine ® .

The Company’s food and beverage brands include Celestial Seasonings ® , Clarks™, Cully & Sully ® , Earth’s Best ® , Ella’s Kitchen ® , Frank Cooper’s ® , Garden of Eatin’ ® , Garden Veggie ™ , Hartley’s ® , Health Valley ® , Imagine ® , Joya ® , Lima ® , Linda McCartney’s ® (under license), MaraNatha ® , Natumi ® , New Covent Garden Soup Co.

® , ParmCrisps ® , Robertson’s ® , Rose’s ® (under license), Sensible Portions ® , Spectrum ® , Sun-Pat ® , Terra ® , The Greek Gods ® , Thinsters ® , Yorkshire Provender ® and Yves Veggie Cuisine ® .

The Company’s personal care brands include Alba Botanica ® , Avalon Organics ® , JASON ® , Live Clean ® and Queen Helene ® .

On December 28, 2021, the Company acquired all outstanding stock of Proven Brands, Inc.

(and its subsidiary That's How We Roll LLC) and KTB Foods Inc., collectively doing business as "That's How We Roll" ("THWR"), the producer and marketer of ParmCrisps ® and Thinsters ® .

See Note 4, Acquisitions and Dispositions, for details.

Discontinued Operations

The Company completed the sale of the former Tilda operating segment and the Hain Pure Protein reportable segment;

these dispositions represented strategic shifts that had a major impact on the Company’s operations and financial results.

Accordingly, the Company is presenting the operating results and cash flows of the Tilda operating segment and the Hain Pure Protein reportable segment within discontinued operations in the prior periods (see Note 4, Acquisitions and Dispositions, in the Notes to the Consolidated Financial Statements included in Item 8 of this Form 10-K ).

All footnotes exclude discontinued operations unless otherwise noted.

Environmental, Social and Governance

We are focused on growing our business sustainably by delivering long-term value for our customers, suppliers, stockholders, employees and the communities where we live and work.

As part of our vision to maximize stakeholder value, we are committed to incorporating environmental, social and related governance (“ESG”) principles into our business strategies and organizational culture.

The “Healthier Way” framework (Healthier Planet, Products, and People) set out in our most recent ESG Report (available at hain.com/company/impact ) provides our guiding principles for ESG initiatives.

We are a global health and wellness company whose purpose is to inspire healthier living for people, communities, and the planet through better-for-you brands.

We have focused our Impact strategy around expanding our commitment to environmentally sound business practices, creating and selling better-for-you products, social and commUpunity impact initiatives and sustainable manufacturing processes.

Our Impact strategy also consists of our environmental, social, and governance (“ESG”) goals along with a commitment to considering long-term social and environmental impacts.

More details about our Impact strategy and goals, including our most recent ESG Report, are available at hain.com/company/impact.

Our ESG Reports and the other information available at hain.com/company/impact are not, and shall not be deemed to be, a part of this Form 10-K or incorporated into any of our other filings made with the Securities and Exchange Commission (the “SEC”).

Human Capital Resources

As of June 30, 2022, we had appro ximately 3,078 employees, with approximately 49% located in North America and approximately 51% located outside of North America.

As of June 30, 2023, we had approximately 2,837 employees, with approximately 46% located in North America and approximately 54% located outside of North America.

Approximately 59% of our employees in North America and approximately 60% of our employees outside of North America were based in our production facilities.

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The following programs, initiatives and principles encompass some of the human capital objectives and measures that we focus on in managing our business and in seeking to attract and retain a talented workforce.

Our Culture and Our Vision, Mission and Values

Our culture is shaped by our vision, mission and values.

Our vision is to inspire healthier living for all.

To achieve this aspiration, our mission is to build enduring health and wellness brands that are known and loved by consumers and enrich the lives of employees and all of our stakeholders.

We live by our values of teamwork, integrity and entrepreneurship – we think and act with a broad company perspective, we do the right thing, and we think in an innovative way and challenge the status quo.

Diversity and Inclusion

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We are continuing to work to build our D&I efforts into recruitment, retention and internal mobility.

As of June 30, 2022, our global wor kforce was 59% male and 41% female.

As of June 30, 2023, our global workforce was 59% male and 41% female.

In the United States, on an employee self-reported basis, the racial/ethnic composition of our workforce was approximately 40% Hispanic or Latino, 42% White, 10% Black or African American, 6% Asian and 2% other.

We make additional workforce demographic data available at hain.com/impact .

The information available at hain.com/impact is no t a part of this Form 10-K or incorporated into any of our other filings made with the SEC.

The information available at hain.com/impact is not a part of this Form 10-K or incorporated into any of our other filings made with the SEC.

Employee Health and Safety

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Our Executive Leadership Team regularly reviews the results and considers and implements action items to address areas that need improvement.

We have additional regional programs and policies in place to

encourage open communications with management and Human Resources about employees’ ideas, concerns and how they are doing.

We have additional regional programs and policies in place to encourage open communications with management and Human Resources about employees’ ideas, concerns and how they are doing.

Our brand portfolio focuses on growing global brands in categories where we believe we have the most potential.

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Conversely, we discontinue products or stock keeping units (“SKUs”) when sales of those items do not warrant further production.

The categories we have identified are called Turbocharge, Targeted Investment, Fuel and Simplify:

• The Turbocharge brands are leading-share brands in what we believe to be very high-growth categories.

The Turbocharge brands are made up of snacks as well as plant-based meat and non-dairy beverages.

Our snacks businesses include brands both within the United States and in our International segment (“International”), while our meat and dairy alternatives businesses are concentrated outside the United States.

Our snack products include a variety of potato, root vegetable and other exotic vegetable chips, straws, tortilla chips, whole grain chips, pita chips and puffs.

The Turbocharge brands accounted for approximately 39% of our consolidated net sales in fiscal 2022, 36% in fiscal 2021 and 32% in fiscal 2020.

• The Targeted Investment brands are made up of leading-share brands in lower-growth categories.

To date, we have demonstrated our ability to drive market share and reinvigorate these categories, and we expect that we can continue to do this in the future.

The Targeted Investment brands are made up of tea, baby, yogurt, and personal care products.

The Targeted Investment brands accounted for approximately 35% of our consolidated net sales in fiscal 2022, 34% in fiscal 2021 and 32% in fiscal 2020.

• The Fuel brands are stable brands that will be leveraged to fuel investment in the Turbocharge and Targeted Investment categories.

Fuel brands are made up of premium pantry brands with scale, in categories such as soup, cooking oils and nut butters.

The Fuel brands accounted for approximately 21% of our consolidated net sales in fiscal 2022, 20% in fiscal 2021 and 19% in fiscal 2020.

• The Simplify brands are subscale declining businesses that we believe have limited long-term potential for the Company, and therefore will be managed for profit until they are potentially divested, likely over the course of the next several years.

Simplify brands accounted for approximately 5% of our consolidated net sales in fiscal 2022, 10% in fiscal 2021 and 17% in fiscal 2020.

We refer to the Turbocharge brands and Targeted Investment brands together as our Growth brands.

Products under different brands for our reportable segments are noted in the segments section.

Certain of our product lines have seasonal fluctuations in demand.

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In recent years, net sales and diluted earnings per share in the first fiscal quarter have typically been the lowest of our four quarters.

Working Capital

For information relating to our cash flows from operations and working capital items, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7 of this Form 10-K.

Our organization structure consists of two geographic based reportable segments:

North America and International.

Our North America reportable segment consists of the United States and Canada as operating segments.

The International reportable segment is made of three operating segments:

United Kingdom, Ella’s Kitchen UK and Europe.

This structure is in line with how our Chief Operating Decision Maker assesses our performance and allocates resources.

We use segment net sales and operating income to evaluate performance and to allocate resources.

We believe these measures are most relevant in order to analyze segment results and trends.

Segment operating income excludes certain general corporate

expenses (which are a component of selling, general and administrative expenses), impairment and acquisition related expenses, restructuring, integration and other charges.

The following table presents the Company’s net sales by reportable segment for the fiscal years ended June 30, 2022, 2021 and 2020 (amounts in thousands, other than percentages):

Fiscal Year Ended June 30,

2022 2021 2020

North America $ 1,163,132 61 % $ 1,104,128 56 % $ 1,171,478 57 %

International 728,661 39 % 866,174 44 % 882,425 43 %

Total $ 1,891,793 100 % $ 1,970,302 100 % $ 2,053,903 100 %

This structure is in line with how our Chief Operating Decision Maker (“CODM”) assesses our performance and allocates resources.

See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7 and Note 19, Segment Information , in the Notes to the Consolidated Financial Statements included in Part II, Item 8 of this Form 10-K for additional details.

North America Segment:

United States

Our products are sold throughout the United States.

Our customer base consists principally of specialty and natural food distributors, supermarkets, natural food stores, mass-market and e-commerce retailers, food service channels and club, drug and convenience stores.

Our products are sol d throughout the United States.

Our customer base consists principally of specialty and natural food distributors, supermarkets and natural food stores, mass-market, club stores, e-commerce retailers, drug and convenience stores, and food service channels.

Our products are sold through a combination of direct salespeople, brokers and distributors.

We believe that our direct salespeople combined with brokers and distributors provide an effective means of reaching a broad and diverse customer base.

We believe that our direct salespeople com bined with brokers and distributors provide an effective means of reaching a broad and diverse customer base.

Brokers act as agents for us within designated territories and receive commissions.

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Food distributors purchase products from us for resale to retailers.

The brands sold by the United States operating segment include:

The Turbocharge brands are leading-share brands in what we believe to be very high-growth categories and they include snacks.

Our snack food products include Sensible Portions ® snack products including Garden Veggie Straws ® , Garden Veggie Chips and Apple Straws ® , Terra ® varieties of root vegetable chips, potato chips, and other exotic vegetable chips, Garden of Eatin’ ® tortilla chips, and ParmCrisps ® .

Targeted Investment

The Targeted Investment brands are made up of leading-share brands in lower-growth categories and they include tea, baby food, yogurt, and personal care.

Our tea products are marketed under the Celestial Seasonings ® brand and include more than 100 varieties of herbal, green, black, wellness, rooibos and chai teas, with well-known names and products such as Sleepytime ® , Lemon Zinger ® , Red Zinger ® , Cinnamon Apple Spice, Bengal Spice ® , Country Peach Passion ® and Tea Well ® .

The brands sold in the United States include:

• Garden Veggie ™ and Sensible Portions ® snack products including Garden Veggie Straws ® , Garden Veggie Chips and Apple Straws ® , Terra ® varieties of root vegetable chips, potato chips, and other exotic vegetable chips, Garden of Eatin’ ® tortilla chips, and ParmCrisps ® .

• Tea products under the Celestial Seasonings ® brand and include more than 100 varieties of herbal, green, black, wellness, rooibos and chai teas, with well-known names and products such as Sleepytime ® , Lemon Zinger ® , Red Zinger ® , Cinnamon Apple Spice, Bengal Spice ® , Country Peach Passion ® and Tea Well ® .

• Baby food products include infant and toddler formula, infant cereals, jarred baby food, baby food pouches, snacks and frozen toddler and kids’ foods under the Earth’s Best ® and Earth’s Best Sesame Street (under license) brands.

• Yogurt products include The Greek Gods ® Greek-style yogurt products.

Our personal care products include hand, skin, hair and oral care products, sun care products and deodorants under the Alba Botanica ® , Avalon Organics ® , JASON ® and Queen Helene ® brands.

Fuel and Simplify

The Fuel brands are stable brands that will be leveraged to fuel investment in the Turbocharge and Targeted Investment categories.

Fuel brands are made up of premium pantry brands with scale, in categories such as soup, cooking oils and nut butters.

The Simplify brands are subscale declining businesses that have limited long-term potential for the Company, and therefore will be managed for profit until they are potentially divested, likely over the course of the next several years.

Fuel and Simplify b rands include the following:

Spectrum ® culinary oils, vinegars and condiments, Spectrum Essentials ® nutritional oils

and supplements, MaraNatha ® nut butters, Imagine ® broths, soups and gravies, Hain Pure Foods ® condiments, Health Valley ® cereal bars and soups, and Hollywood ® oils.

• Personal care products include hand, skin, hair and oral care products, sun care products and deodorants under the Alba Botanica ® , Avalon Organics ® , JASON ® and Queen Helene ® brands.

• Other products include Spectrum ® culinary oils, vinegars and condiments, Spectrum Essentials ® nutritional oils and supplements, MaraNatha ® nut butters, Imagine ® broths, soups and gravies, Hain Pure Foods ® condiments, Health Valley ® cereal bars and soups, and Hollywood ® oils.

Our products are sold throughout Canada.

Our customer base consists principally of grocery supermarkets, mass merchandisers, club stores, natural food distributors, personal care distributors, drug store chains and food service distributors.

Our customer base consists principally of grocery supermarkets, club stores, mass merchandisers, natural food distributors, drug store chains, personal care distributors, and food service distributors.

Our products are sold through our own retail direct sales force.

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As in the United States, a portion of the products marketed by us are sold through independent distributors.

The brands sold in our Canada operating segment include Yves Veggie Cuisine ® refrigerated and frozen meat-alternative products, vegetables and lentils, Earth’s Best ® infant formula, MaraNatha ® nut butters, Spectrum ® cooking and culinary oils, Imagine ® aseptic soups, The Greek Gods ® Greek-style yogurt and Robertson’s ® marmalades.

Other food brands include Celestial Seasonings ® teas, Terra ® chips and Sensible Portions ® snack products.

The brands sold in Canada include Yves Veggie Cuisine ® refrigerated and frozen meat-alternative snacks and meals, vegetables and lentils, Earth’s Best ® infant formula, MaraNatha ® nut butters, Spectrum ® cooking and culinary oils, Imagine ® aseptic soups, The Greek Gods ® Greek-style yogurt and Robertson’s ® marmalades.

Other food brands include Celestial Seasonings ® teas, Terra ® chips and Garden Veggie ™ and Sensible Portions ® snack products.

Our personal care products include skin, hair and oral care products, sun care products and deodorants under the Alba Botanica ® , Avalon Organics ® , JASON ® , and Live Clean ® brands.

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United Kingdom

In the United Kingdom, our products include soups, plant-based and meat-free products, as well as ambient products such as jams, fruit spreads, jellies, honey, marmalades, nut butters, sweeteners, syrups and dessert sauces.

The products sold by our United Kingdom operating segment include New Covent Garden Soup Co.

® and Yorkshire Provender ® chilled soups, private label and Farmhouse Fare ™ hot-eating desserts, Linda McCartney’s ® (under license) chilled and frozen plant-based meals, Hartley’s ® jams, fruit spreads and jellies, Sun-Pat ® nut butters, Clarks™ natural sweeteners and Robertson’s ® , Frank Cooper’s ® and Rose’s ® (under license) marmalades.

We also provide a comprehensive range of private label products to many retailers, convenience stores and food service providers in the following categories:

fresh soup, chilled desserts, meat-free meals and ambient grocery products.

Our products are principally sold throughout the United Kingdom and Ireland, but are also sold in other parts of the world.

In the United Kingdom, our products include soups, plant-based and meat-free dishes and meals, as well as ambient products such as jams, fruit spreads, jellies, honey, marmalades, nut butters, sweeteners, syrups and dessert sauces.

The products sold in the United Kingdom include Ella's Kitchen ® premium organic infant and toddler foods, New Covent Garden Soup Co.

® and Yorkshire Provender ® chilled soups, private label and Farmhouse Fare ™ hot-eating desserts, Linda McCartney’s ® (under license) chilled and frozen plant-based dishes and meals, Hartley’s ® jams, fruit spreads and jellies, Sun-Pat ® nut butters, Clarks™ natural sweeteners and Robertson’s ® , Frank Cooper’s ® and Rose’s ® (under license) marmalades.

We also provide a comprehensive range of private label products to many grocery and organic food retailers, convenience stores and food service providers in the following categories:

fresh soup, chilled desserts, meat-free dishes and meals and ambient grocery products.

Our products are principally sold throughout the United Kingdom and Ireland but are also sold in Europe and other parts of the world.

Our customer base consists principally of retailers, convenience stores, food service providers, business to business, natural food and ethnic specialty distributors, club stores and wholesalers.

Ella’s Kitchen UK

Ella's Kitchen UK is a manufacturer and distributor of premium organic infant and toddler foods under the Ella's Kitchen ® brand.

Our products are mostly sold in grocery stores and organic food stores throughout the United Kingdom and Europe.

Our products sold by the Europe operating segment include, among others, products sold under the Joya ® , Lima ® and Natumi ® brands.

Our products sold by the Europe reporting unit include, among others, products sold under the Joya ® , Lima ® and Natumi ® brands.

The Lima ® brand includes a wide range of organic products such as soy sauce, plant-based beverages and grain cakes, as well as grains, pasta, cereals, miso, snacks, sweeteners, spreads, soups and condiments.

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Our Joya ® brand includes soy, oat, rice and nut-based drinks as well as plant-based yogurts, desserts, creamers and tofu.

We also sell our Hartley’s ® jams, fruit spreads and jellies, Terra ® varieties of root vegetable and potato chips, Celestial Seasonings ® teas, Linda McCartney’s ® (under license) chilled and frozen plant-based meals, Cully & Sully ® chilled soups and ready meals, and private label products in Europe.

We also sell our Hartley’s ® jams, fruit spreads and jellies, Terra ® varieties of root vegetable and potato chips, Celestial Seasonings ® teas, Linda McCartney’s ® (under license) chilled and frozen plant-based dishes and meals, Cully & Sully ® chilled soups and ready meals, and private label products in Europe.

Our products are sold in grocery stores and organic food stores throughout Europe, the Middle East and India.

Our products are sold using our own direct sales force and local distributors.

and its affiliates together accounted for approximately 15%, 11% and 12% of our consolidated sales for the fiscal years ended June 30, 2022, 2021 and 2020, respectively, which were primarily related to the United States, Canada and United Kingdom operating segments.

and its affiliates together accounted for approximately 16%, 15% and 11% of our consolidated sales for the fiscal years ended June 30, 2023, 2022 and 2021, respectively, which were primarily related to the United States, Canada and United Kingdom.

No other customer accounted for at least 10% of our net sales in any of the past three fiscal years.

Foreign Operations

We sell our products to customers in more tha n 75 co untries.

We sell our products to customers worldwide.

Sales outside of the United States represented approximately 43%, 45% and 52% of our consolidated net sales in fiscal 2023, 2022 and 2021, respectively.

We aim to meet the consumer at multiple points in their journey, both pre-shop and during purchase, both in-store and online.

We aim to meet the consumer at multiple points in their journey, across the digital and omnichannel ecosystem, communicating both in-store and online.

We use a combination of trade and consumer advertising and promotion.

Trade advertising and promotion includes placement fees, cooperative advertising, feature advertising in distribution catalogs and in-store merchandising in prominent and secondary locations.

Consumer advertising and promotion is used to build brand awareness and equity, drive trial to bring in new consumers and increase consumption.

Paid social and digital advertising and public relations programs are the main drivers of brand awareness.

Consumer advertising and promotion is used to build brand awareness and equity, drive trial to bring in new consumers and retain existing users to increase household penetration and consumption.

Paid social and digital advertising, including retailer media and public relations programs, are the main drivers of brand awareness.

Trial and conversion tactics include, but are not limited to, product search on Google and e-commerce sites, digital coupons, product sampling, direct mail and e-consumer relationship programs.

Additionally, brand specific websites and social media pages are used to engage consumers with lifestyle, product and usage information related to specific brands.

We also utilize partnerships to help create awareness and advocacy.

We partner with various influencers to help increase brand reach and relevance.

For example, one of our personal care brands, Alba Botanica ® , had a full year partnership with USA Olympic and World Tour Surfer, Caroline Marks.

Also, our Earth’s Best ® brand has an agreement with PBS Kids and Sesame Workshop in the United States, leveraging popular characters for on and off packaging communications.

We also utilize marketing arrangements with third parties to help create awareness and advocacy.

For example, our Earth’s Best ® brand has an agreement with PBS Kids and Sesame Workshop in the United States, leveraging popular characters for on and off packaging communications.

We also leverage various influencers to help increase brand reach and relevance.

New Product Initiatives Through Research and Development

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• Boulder, Colorado, which produces Celestial Seasonings ® teas;

• Mountville, Pennsylvania, which produces Sensible Portions ® and Terra ® snack products;

• Mountville, Pennsylvania, which produces Garden Veggie ™ , Sensible Portions ® and Terra ® snack products;

• Bell, California, which produces Alba Botanica ® , Avalon Organics ® , and JASON ® personal care products;

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• York, Pennsylvania, which produces ParmCrisps ® ;

• Trenton, Ontario, which produces Yves Veggie Cuisine ® plant-based products;

• Vancouver, British Columbia, which produces Yves Veggie Cuisine ® plant-based products;

• Vancouver, British Columbia, which produces Yves Veggie Cuisine ® plant-based snacks and meals;

• Mississauga, Ontario, which produces our Live Clean ® and other personal care products.

Our International reportable segment operates the following manufacturing facilities:

• Histon, England, which produces our ambient grocery products inc luding Hartley’s ® , Frank Cooper’s ® , Robertson’s ® and Clarks™;

• Histon, England, which produces our ambient grocery products including Hartley’s ® , Frank Cooper’s ® , Robertson’s ® and Clarks™;

• Grimsby, England, which produces our New Covent Garden Soup Co.

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• Clitheroe, England, which produces our private label and Farmhouse Fare TM hot-eating desserts;

• Fakenham, England, which produces Linda McCartney’s ® (under license) meat-free frozen a nd chilled foods;

• Fakenham, England, which produces Linda McCartney’s ® (under license) meat-free frozen and chilled dishes and meals;

• Troisdorf, Germany, which produces Natumi ® , Lima ® , Joya ® and other plant-based beverages and private label products;

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Agricultural commodities and ingredients are subject to price volatility which can be caused by a variety of factors.

Our input costs began to increase significantly beginning in the latter part of fiscal 2021.

That inflationary environment extended in fiscal 2022, and we expect the inflationary environment to continue throughout fiscal 2023.

We attempt to mitigate the input price volatility by negotiating and entering into purchase arrangements with our suppliers and by adjusting the sale price of our products.

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Large conventional packaged foods competitors include Campbell Soup Company, Conagra Brands, Inc., Danone S.A., General Mills, Inc., The Hershey Company, The J.M.

Smucker Company, Kellogg Company, Mondelez International, Inc., Nestle S.A.,

PepsiCo, Inc.

Smucker Company, Kellogg Company, Mondelez International, Inc., Nestle S.A., PepsiCo, Inc.

and Unilever PLC.

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We utilize a comprehensive product safety and quality management program, which employs strict manufacturing procedures, expert technical knowledge on food safety science, employee training, ongoing process innovation, use of quality ingredients and both internal and independent auditing.

In the United States, each of our own food manufacturing facilities has a Food Safety Plan (“FSP”), which focuses on preventing food safety risks and is compliant with the requirements set forth under the Food Safety and Modernization Act (“FSMA”).

In addition, each such facility has at least one Preventive Controls Qualified Individual (“PCQI”) who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized by the FDA.

In addition, each such facility has at least one Preventive Controls Qualified Individual (“PCQI”) who has successfully completed training equivalent to that received under a standardized curriculum recognized by the FDA.

We conduct audits of our contract manufacturers to address topics such as allergen control;

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and sanitation.

Under FSMA, each of our contract manufacturers is required to have a FSP, a Hazard Analysis Critical Control Plant (“HACCP”) plan or a hazard analysis critical control points plan that identifies critical pathways for contaminants and mandates control measures that must be used to prevent, eliminate or reduce relevant food-borne hazards.

Independent Certifications

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business