What Do Food Brands Need to Know About U.S. Mainstream Compliance?

The U.S. food market is complex, requiring non-U.S. brands to navigate not only FDA regulations but also stringent mainstream compliance standards set by private retailers. With federal agencies like the USDA and FDA playing significant roles and California's strict food safety laws influencing national standards, understanding these comprehensive compliance requirements is crucial for brands seeking success in the competitive U.S. food market.

What Do Food Brands Need to Know About U.S. Mainstream Compliance?

Imagine a world without a standard set of rules and regulations—like no law and order. It would be chaos! The same applies to all industries; without adhering to rules and regulations, businesses could not function for a single day. That’s why compliance with standards is necessary for sustainable business operations.

For the US food industry, compliance can be difficult to navigate, particularly if a non-US food brand aims to get products on the shelves of big-name stores like Walmart, Kroger, and Whole Foods. Many food brands may undervalue the significance of mainstream compliance while concentrating on adhering to only FDA requirements. Unlike FDA regulations, private retailers impose stringent requirements for mainstream compliance, which is necessary to enter the mainstream market in the United States.

This article explores what food brands need to know about mainstream compliance, outlining the key differences from FDA regulations and explaining why strict adherence is vital for long-term success in the competitive U.S. food market.

How Do the FDA and States Coordinate Food Safety in the U.S.?

Government Level:

The U.S. food safety system is a complex network involving multiple agencies and levels of government. It is governed by 30 federal laws and regulations administered by 15 federal agencies. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) share primary responsibility for overseeing the safety of the U.S. food supply. All states have their own laws, regulations, and agencies dedicated to food safety. The federal Centers for Disease Control and Prevention (CDC) are mainly responsible for investigating localized and nationwide outbreaks of foodborne illnesses.

The FDA and USDA often overlap in food safety functions, such as inspection/enforcement, training, research, and rulemaking, for both domestic and imported food. Both the USDA and FDA conduct similar inspections at 1,500 dual-jurisdiction establishments that produce foods regulated by both agencies. The USDA has primary responsibility for the safety of meat, poultry, and certain egg products, with regulatory authority coming from the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, and the Humane Methods of Livestock Slaughter Act.

The FDA is authorized by the Food, Drug, and Cosmetic Act and the Public Health Service Act to regulate foods other than meat and poultry products, as well as medications, medical devices, biologics, animal feed, drugs, cosmetics, and radiation-emitting equipment. The FDA does not regulate the retail section, which includes supermarkets and grocery stores. That’s where states come in, as they have their own set of standards that these grocery chains need to adhere to.

The Centers for Disease Control and Prevention (CDC) coordinates government efforts to collect data on foodborne illnesses, investigate outbreaks, and evaluate prevention and control initiatives.

State and Local Levels:

State and local health authorities are in charge of surveillance, and the extent to which these actions are carried out varies greatly depending on jurisdiction. The U.S. Department of Health and Human Services (HHS) oversees food safety in retail food establishments, with over 3,000 agencies responsible for this. Many jurisdictions have a split between agriculture and health department authority, which is similar to the division in federal food safety authorities. In most state and local governments, for example, the health department has responsibility over restaurants, but the agriculture department has control over supermarkets. Thus, a restaurant in a supermarket may be governed by the agriculture department, while a stand-alone restaurant in the same chain is governed by the health department. Health and agriculture departments in the same jurisdiction, like the FDA and USDA, are typically controlled by distinct regulations, utilize different methodologies and standards, and have different cultures, all of which influence their regulatory approach.[1]

The USDA's Food Safety and Inspection Service (FSIS) monitors state inspections of meat and poultry sold in the state. State inspection programs must be "at least equal to" federal standards, and the federal FSIS takes over if a state ends its inspection programs or fails to maintain the standard. In some states, state employees conduct inspections in federally operated plants under cooperative inspection contracts.[2]

Thus, each state in the United States has its own set of laws and regulations; therefore, it differs greatly. Some states have their inspection procedures for products produced and marketed solely within their borders, such as meat, replacing the need for federal USDA inspections. Other states have their pesticide testing regulations for fruits and vegetables grown within the state.[3]

In conclusion, the United States food safety system operates through a complicated interaction of federal monitoring and state-level rules, resulting in varied standards among jurisdictions. This diverse regulatory landscape emphasizes the significance of coordination and adherence to both federal and state rules in ensuring public health and safety.

Figure 1

How Does Mainstream Compliance Extend Beyond FDA?

Mainstream compliance is a set of regulations and food quality standards set by private parties and retailers. These standards go beyond the FDA's regulations, and compliance with them is necessary to enter the mainstream market. Unlike the FDA, these standards can vary for each retailer.

Anyone aiming to take their food brand to mainstream retail chains such as Whole Foods, Kroger, Costco, etc. needs to comply with their specific standards. No compliance with mainstream standards means zero chance of getting your food products to the shelves of mainstream retailers.

Typically, the food supply chain in the U.S. includes distributors, manufacturers, and retailers while for non-US brands, there is an addition of importers as well.[4] To enter the mainstream market, compliance by all these bodies is mandatory. Hence, mainstream compliance is not just for the brand owner. It needs to be met by all the parties, mainly the brand, distributor, and importer. If any one of these fails to adhere to mainstream compliance, the products can never enter the mainstream market.

Let’s take a look at some of the well-known retailers and just a few examples of the standards set by them.

ALDI:

  • Private label food production facilities must be GFSI certified.
  • Warehouse facilities must be GMP certified.

Amazon:

  • Requires GFSI certification for chilled/frozen foods and high-risk raw produce.
  • Dietary supplements need GMP certification or participation in specific certification programs.

Costco:

  • Requires a GMP audit called the "Costco Food Safety Audit".

Kroger:

  • Vendors for Kroger private label items must be GFSI certified for each manufacturing plant.

Target:

  • All Target-branded food production facilities must have GFSI-recognized certification.

Walmart:

  • Requires GFSI-recognized certification and local, state, and federal inspections are not accepted.
  • Small fresh produce suppliers may complete alternative food safety certification audits.

Whole Foods Market:

  • Accepts either GFSI-recognized audits or non-GFSI audits depending on the supplier type. [5]

For each of the chains mentioned above, the food manufacturers, importers, and distributors must comply with their standards to get their products to the mainstream market. This is what mainstream compliance is all about. The graphic below represents a few of the major retailers and examples of their standards. [6] [7]

Figure 2

How Does Mainstream Compliance Differ from FDA Compliance?

Mainstream compliance is much broader than the FDA. The table below highlights the key differences between them.

FDA Compliance Mainstream Compliance
FDA compliance is the observance of guidelines and regulations established by the US FDA to guarantee efficacy and safety. Mainstream compliance is the set of food quality standards set by private entities and retailers that are to be met by the food brands.
Compliance with these is necessary to set foot in the U.S. market. Compliance with these is necessary to enter the mainstream market including chains like Whole Foods, Target, Kroger, etc.
These are a uniform set of rules and are specific across the country. These can vary from entity to entity.
Non-compliance leads to regulatory penalties. Non-compliance leads to no entry into the mainstream market.
Example: The FDA controls the safety of products that are added to food directly as well as materials that come into contact with food like compounds added to cookware, packaging, or storage containers. Example: Whole Foods requires that all ingredients should be listed clearly on the label of the product, and the labels must adhere to all applicable federal, state, and local laws. Allergens must be mentioned on the labels per FALCPA10.

Thus, FDA and mainstream compliance are not the same, and having only FDA compliance is not enough to enter the mainstream market.

Why is California at the Forefront of Mainstream Standards?

California, the Golden State, has been the fifth-largest economy in the world since 2017, with a GDP of nearly $3.9 trillion in 2023. [11] It is known for its varied agricultural practices and abundant food production. The state of California has the toughest food regulatory requirements, and mainstream retailers comply with these standards as they want to operate in California, the largest economy in the United States, contributing 14% of the country’s GDP. [12]

California leads the nation in production of fruits, vegetables, nuts, and dairy products. The state is responsible for 13% of agricultural produce and creates around 62% of the value of fruits and nuts in the U.S.[13] With such facts, the importance of California’s agricultural output cannot be overstated, as it keeps contributing substantially to the national economy and food security.

Given below is a little overview of the food laws that are imposed by the state of California that are to be met by mainstream retailers if they want to operate in the state:

  • The California Department of Food and Agriculture (CDFA) is the primary regulatory organization. It upholds food laws to safeguard public health and promote the agriculture sector.[14]
  • Proposition 65: an act requiring comprehensive labeling to warn customers about toxic chemicals in products, is at the forefront of California's laws.
  • California Retail Food Code: To prevent foodborne illnesses, the California Retail Food Code (CalCode) establishes food safety guidelines for retail food establishments. These guidelines address food handling, storage, staff hygiene, sanitation, and equipment maintenance.
  • Critical Control Points and Hazard Analysis (HACCP): Mandatory for some food processors (dairy, juice, seafood, etc.) to systematically detect and control risks to food safety.
  • California Food Safety Act (CFSA): It is the first law in the United States to prohibit the production, marketing, and distribution of food products that include particular additives, i.e., brominated vegetable oil, potassium bromate, propylparaben, or red dye No. 3, due to their carcinogenic risks and other health concerns. Manufacturers must modify recipes to eliminate these additives, addressing public concerns about carcinogens and endocrine disruptors. Retailers will not be able to sell products containing these food additives after 2027. [15]

The laws of the state of California are much more stringent than those of government regulatory bodies like the FDA. For example, the use of per- and polyfluorinated substances (PFAS), often known as “forever chemicals,” is allowed by the FDA under certain circumstances. Still, many of the US states have issued strict regulations, including a complete ban on them by the state of California.[16] Such regulations by California are bound to have an impact on mainstream food standards, as it is not feasible for any brand owner to have two sets of products, one to be sold in California and the other in the remaining states. So, having one set of products means complying with standards set by California and selling them nationwide. This is how California impacts mainstream compliance standards across the U.S. [17]

Figure 3

Why is Mainstream Compliance Necessary for Mainstream Market Access?

Mainstream compliance is required to enter the U.S. mainstream market. In the U.S., mass merchandisers, drugstores, grocery shops, convenience stores, and food service facilities are all included in the food retail sector. Large corporations at the forefront of this industry include Walgreens, Kroger, and Walmart. [18] These retailers, along with others like Whole Foods, Costco, etc., are the gatekeepers to the U.S. food system, and they determine which products travel from farms to their shelves.[19]

The mainstream market, including retailers and well-known grocery chains, makes up 90% of the overall grocery market in the U.S. worth over $1 trillion. The standards set by these parties are mandatory to be followed by the food brands, distributors, and importers. But what can achieving mainstream compliance do for a brand? Let’s understand:

Mainstream compliance means access to the big supermarkets and grocery chains in the U.S.

  • To reach a large number of consumers, food brands must have access to significant retail chains. Supermarkets such as Whole Foods, Walmart, and Kroger are great venues for brand exposure and sales. Without mainstream compliance, brands cannot take advantage of such opportunities.

Non-compliance means no entry into the mainstream market, and retailers are very strict when it comes to complying with their standards.

  • Retailers impose strict guidelines to guarantee the quality, safety, and satisfaction of their customers. For example, when it comes to Whole Foods, if the product is not free of chemicals and ingredients on its “unacceptable list,” it is rejected right away. By strictly adhering to standards, the chain maintains its credibility. [20]

The standards set by mainstream retailers can keep changing which means even if the product was on the shelf before, non-compliance can lead to the removal of the product from the shelves.

  • Retailers often revise their compliance criteria in response to evolving regulations, customer preferences, and new health research. For example, Whole Foods keeps changing its list of ingredients. If the previous products on the shelves do not comply with the updated requirements, the product is pulled from the shelves. [21]

Mainstream compliance means getting a pass to enter the mainstream landscape, which means getting access to a large and lucrative market. This can help the business grow on an international level. [22]

  • For example, platforms like Amazon, Walmart, and Costco can help position a brand for worldwide distribution, given their extensive global reach. The capacity to reach international markets can greatly increase a business's potential for growth and profitability.[23]

Once mainstream compliance is achieved, small food brands can make their businesses successful by getting support from major supermarkets and grocery chains.

  • For example, Whole Foods gives opportunities to local products to support small brands thus giving them exposure and a chance to grow.[24]

Due to achieving mainstream compliance, trust among consumers is built as the product has passed such strict standards, which leads to business success and a loyal customer base. [25]

  • When a product passes the rigorous standards of major retailers, it signals to customers that it is reliable, safe, and of good quality. Gaining this trust is essential to establishing a loyal customer base. Customers who believe a brand is reliable and dedicated to quality are more likely to become devoted supporters. This dedication eventually results in consistent company success and a significant market presence.

Thus, it’s really important for any food brand aiming to succeed in the US market to completely adhere to the mainstream regulations.

Conclusion:

Navigating the U.S. food market requires more than just meeting federal regulations; it demands a deep understanding of mainstream compliance standards set by private entities. Mainstream compliance is not only necessary but also a competitive advantage in the US food retail industry. It makes it possible for the brand to enter the U.S. mainstream market, including major retailers, guarantees ongoing product relevance, helps small brands succeed, fosters customer confidence, and improves brand recognition. Mainstream compliance is crucial to long-term growth and sustainability for any food brand hoping to compete in the competitive U.S. mainstream market.

References:

[1] National Academies Press (US). “The Current US Food Safety System.” Ensuring Safe Food - NCBI Bookshelf, 1998, www.ncbi.nlm.nih.gov/books/NBK209121.

[2] Longley, Robert. “The US Food Safety System.” ThoughtCo, 4 June 2019, www.thoughtco.com/the-us-food-safety-system-3321054.

[3] The US Food Safety System Explained | FoodStorm. www.foodstorm.com/blog/the-us-food-safety-system-explained.

[4] Wunderlich, Shahla M., and Marielle Smoller. “FOOD SUPPLY CHAIN IN THE UNITED STATES: POTENTIAL ENVIRONMENTAL IMPACT.” WIT Transactions on Ecology and the Environment, June 2018, https://doi.org/10.2495/eid180231.

[5] Kellerman, Phoebe. “Top 12 grocery stores & retailers requiring food safety audits for suppliers.” Kellerman Consulting, 8 Aug. 2023, kellermanconsulting.com/top-12-grocery-stores-retailers-requiring-food-safety-audits-for-suppliers.

[6] “Whole Foods Market | ExchangeRight.” ExchangeRight, www.exchangeright.com/tenant-profiles/whole-foods-market.

[7] “Largest Retailers in the U.S. and the World (as of 2024): Full List.” Capital One Shopping, 31 July 2024, capitaloneshopping.com/research/largest-retailers.

[8] Weever. “The Costs of Non-Compliance for Food Manufacturers | Weever.” Weever, 29 May 2023, weeverapps.com/compliance-management/non-compliance-costs.

[9] Nutrition, Center for Food Safety and Applied. “Food Ingredients and Packaging.” U.S. Food And Drug Administration, 6 July 2023, www.fda.gov/food/food-ingredients-packaging.

[10] Whole Foods Market. Whole Foods Market® Supplier Guidelines. 1.2, p2pi.com/file/PtPI162e18538d8d40612813678/Whole Foods Supplier Guidelines.pdf.

[11] Danelladebel. “California Remains the World’s 5th Largest Economy | Governor of California.” Governor of California, 15 May 2024, www.gov.ca.gov/2024/04/16/california-remains-the-worlds-5th-largest-economy.

[12] New Zealand Ministry of Foreign Affairs and Trade. “California Dreaming: Golden State Economic Review - February 2024.” New Zealand Ministry of Foreign Affairs and Trade, 1 Feb. 2024, www.mfat.govt.nz/en/trade/mfat-market-reports/california-dreaming-golden-state-economic-review-february-2024.

[13] The Importance of Agriculture to the Economy of California’s Central Coast | Community West Bank. www.communitywestbank.com/blog/agriculture-and-california-economy.php.

[14] Libretexts. “15.2: Food Laws for the State Of California.” Medicine LibreTexts, 29 July 2023, med.libretexts.org/Courses/Sacramento_City_College/NUTRI_335%3A_Principles_of_Food_Science
_(Coppola)/15%3A_Food_Rules_and_Regulations/15.02%3A_Food_laws_for_the_State_of_California
.

[15] AIB International. The 5 Biggest Takeaways From the New California Food Safety Act. 22 Apr. 2024, blog.aibinternational.com/the-5-biggest-takeaways-from-the-new-california-food-safety-act.

[16] Executive, Food Industry. California Food Safety Act Widens the Gap Between State and Federal Food Regulations. 23 Jan. 2024, www.linkedin.com/pulse/california-food-safety-act-widens-gap-between-slave

[17] Foodnavigator-usa.com. “California Food Safety Act Signed Into Law, Bans Four Food Additives by Jan. 2027.” foodnavigator-usa.com, 10 Oct. 2023, www.foodnavigator-usa.com/Article/2023/10/10/California-Food-Safety-Act-signed-into-law-bans-four-food-additives-by-Jan.-2027.

[18] “Topic: Food Retail in the United States.” Statista, 16 May 2024, www.statista.com/topics/1660/food-retail.

[19] SmartSense. Achieving Zero Grocery Food Waste at Supermarkets. blog.smartsense.co/supermarkets-zero-food-waste.

[20] “Us Grocery Industry Statistics.” Gitnux, 16 May 2024, gitnux.org/us-grocery-industry.

[21] “What You Need to Know Before Pitching to Whole Foods.” Medium, 9 July 2018, podfoodsco.medium.com/what-you-need-to-know-before-pitching-to-whole-foods-18b57882b489.

[22] Griffioen, Alfred. Closing Deals With Supermarkets in the USA: Brokers and Distributors. 1 Feb. 2023, www.linkedin.com/pulse/closing-deals-supermarkets-usa-brokers-distributors-griffioen-.

[23] Amazon Marketplaces Worldwide: Revenue and Growth. 15 May 2024, www.blankspace.eu/blog-posts-en/amazon-marketplaces-worldwide.

24] Foods, Pod. “How to Sell Your Food Product to Grocery Stores (Part 1).” Medium, 12 Dec. 2021, podfoodsco.medium.com/how-to-sell-your-food-product-to-grocery-stores-part-1-d49383850793.

[25] “Food safety: Ensuring Food Safety Compliance: A Recipe for Success.” Fastercapital, 13 Apr. 2024, fastercapital.com/content/Food-safety--Ensuring-Food-Safety-Compliance--A-Recipe-for-Success.html.

Aamninah Ali
Published: Oct 15, 2024
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