Adulteration

Economic adulteration may be a misnomer. Typically when the Act enforces provisions related to economic harm, deception, or fraud where there is no physical risk, it does so as misbrandings . Misbrandings will be discussed in the next chapter, but can generally be described as labeling offenses. The distinction between misbranding and adulteration lies in the enforcement tools the agency can use.

Adulteration allows the agency to move quickly with little proof of adulteration . The bulk of adulteration refers to areas of potential injury, which requires immediateand swift action. Thus, the FDA can make multiple seizures or administrative detention of adulterated foods . Misbranded items in many cases lack the immediacy of adulteration. Some cases like labels failing to declare an allergen may be an exception. When the concept is limited to fraudulent claims, imposing only economic harm it is much harder for the FDA to act.

Economic adulteration shares the characteristics of misbranding but carries the enforcement triggers of adulteration. It is a hybrid creature born of the circumstances of the 1906 Act. Economic adulteration bears little, if any, difference between other fraudulent statements made on a label. It relates to ingredients, whereas other claims may relate to health benefits or product features. Yet for no reason other than historical happenstance the use of inferior ingredients passed off as superior ones is treated as adulteration. Only when considering the history of the 1906 Act does this make sense.

The 1906 Act arouse out of a tumultuous period of food production. This text in previous chapters described the findings of Upton Sinclair . It was not only in meat packing plants that deplorable conditions and acts were found. It was fairly pervasive throughout the food industry. It is likely that this lingering fear and revulsion of abuse of trust in food production is what continues to keep these acts classified as adulteration .

Economic adulteration is the first area of law where we encounter concurrent jurisdiction with a federal agency that is unaffiliated with food regulation . In 1914 Congress provided the Federal Trade Commission (FTC ) to enforce deceptive commercial practices. This came in the form of the Wheeler Lea Act. The FTC interprets its enabling acts to provide it authority to stop the sale of food products that deceive the public or provide the seller an unfair advantage in the market.

The FDA exercises primary control over economic adulteration . As will be seen with misbranding, the FTC largely defers to the FDA on economic adulteration. The agencies operate under a working agreement which outlines the boundaries of authority (FDA-FTC MOU).⁷ Under the working agreement the two agencies will either act concurrently or through case referrals. The FTC claims jurisdiction over advertising and marketing and the FDA ischarged with regulating the labeling. Labeling leaves the FDA in control of the standards on what constitutes economic adulteration. The reason being the front of the label will declare the product’s identity, such as blueberry muffins, and the ingredient panel will declare ingredients , like blueberry bits (see Modern Examples on p.78). This is the only area of adulteration where the FTC can exercise authority. In every other place the FTC can act in relation to marketing and claims. This again raises the question why economic adulteration is not a misbranding offense. The two agencies are moving towards cooperation rather than competition, as will be discussed in Chapter 4 even issuing joint warning letters.

The 1906 Act attempted to regulate economic adulteration . The Act began with a general definition of adulteration. Language like “substitutions,” however, could be broadly interpreted to preclude any modern developments in food production. Seemingly aware of the impediment Section 7 the drafters added two important exemptions.

The exemptions were necessary to make the economic definition work but were also prone to abuse. Section 8 on misbranding provided two labeling requirements which, if followed, allowed modern processed foods. The first exemption is known as the “distinctive name” exemption . The most infamous example is “Bred Spread” which is neither peanut butter nor jam, but its own distinctive name (see Fig. 3.5). Another early example was “Grape-Smack” which was imitation grape juice. Section 8 allowed a fabricated food on the market if it was labeled with a distinctive name. A second provision allowed compounds, imitations, or blends if proper labeled. Thus, rather than “butter” a label could bear the statement “imitation butter.” Under the distinctive names and imitation exemptions honest manufacturers could develop and sell new innovative foods. It also worked to effectively gut the economic adulteration provisions.

Enforcing the distinctive names exemption proved challenging. Manufacturers quickly learned to adopt distinctive names and claim compliance with Section 8. Grape-Smack, for example, escaped enforcement for economic adulteration . The imitation grape juice contained calcium acid phosphate and corn starch, but was labeled with the initials of a more expensive brand, “C.A.P.” (100 Barrels of Calcium Acid Phosphate).⁸ The courts were soon flooded with cases focused not on the inferior ingredients or alleged fraud , but on whether names likes “Macaroons” or “Maple Flavo” were distinctive names. This was an abstruse and bizarre consequence of the Section 8 distinctive names exemption.

The second exemption did not fare any better in court. The exemption was written broadly to provide safe harbor to any product labeled “compound,” “imitation,” or “blend.” Some courts interpreted this language plainly giving shelter to any product appropriately labeled. Other courts read Sections 7 and 8 together and required the ingredients of the compound to be listed. For instance one court found “Fruit Wild Cherry Compound” (Weeks)⁹ not economically adulterated because it was labeled “compound,” but a second court found “Compound Ess Grape” (Schider)¹⁰ economically adulterated despite complying with Section 8 because it listed a single ingredient imitation grape essence. Litigation was unpredictable and the ease of challenging the FDA left few cases resolved administratively.

For over 30 years courts, industry,` and the FDA suffered under the 1906 economic adulteration fiasco. The 1938 Act directly addresses all of the concerns raised, enforcing the economic adulteration provisions between 1906 and 1938. It resolves all of the confusion and abuses of the 1906 Act. It began by striking the distinctive names and imitation exemption, then added new provisions to take their place.

The 1938 Act replaced distinctive names with standards of identity . The FDA gained new authority to created standards of identity for each food product following public notice and hearing. No longer would “Bred Spred” escape enforcement as economically adulterated. If it did not meet the standard of identity for peanut butter or jam then it was economically adulterated. It could continue to be its own non-standardized product, but it would need to label itself imitation and state its ingredients on the label. Thus a product either meets a standard of identity or must be labeled imitation and list all its ingredients. It could also petition the FDA under 21 CFR 130.5 to create a new standard of identity for its product. The petition is not unique to standards of identity but is called a citizens petition , which can be used for a variety of purposes.

The same definition of economic adulteration from the 1906 Act continues today. The 1938 Act did not change the overall definition of economic adulteration. It remains as broad and unworkable today as it was when enacted over a hundred years ago. Absent the exemptions to provide some boundaries defining economic adulteration, the provision is ambiguous. Many commentators describe economic adulteration as too broad to interpret plainly and too ambiguous to be interpret intelligently.

Economic adulteration is not a relic of the past. It remains as vibrant and attractive cost-saving measure as it was in ancient Rome, Greece, or China. Many modern examples highlight the use and lack of enforcement over economic adulteration. For instance, blueberries are an expensive but highly marketable ingredient. Read your labels carefully. Does that package list real blueberries? In 2011 a consumer advocacy group found several products claiming blueberries, such as blueberry bagels, muffins, and cereals that did not contain actual blueberries. Many labels instead claimed “blueberry bits” which included sugar, food dye, and corn syrup. Unsuspecting consumers would buy the product believing it contained a superior ingredient, blueberries, when it actually contained an inferior ingredient, blueberry bits. This lead to several labeling lawsuits as discussed in Chapter 7. Blueberry bits are a classic example of economic adulteration and one that went unenforced by the FDA .

Most filth is unavoidable. As unsettling as it may seem food will never be defect-free. Insect parts for example are an accepted element of harvesting everything from grapes to cocoa. Similar to the tolerances for added substances, the FDA sets “action levels ” for unavoidable poisonous or deleterious substances. Tolerances and action levels are similar in that both set a maximum level for a substance that could pose harm. Tolerances, however, as intentionally added substances are subject to a formal rule. The FDA will provide public notice and hold hearings before setting a tolerance. The tolerance is then giving the full force of law as if it were part of the Act. Action levels are informal judgment on the quantities of a particular contaminant that will not pose a health risk. Action levels, therefore, represent a promise by the FDA not to enforce any level of contamination from unavoidable sources but only commit to formal enforcement when a threshold or action level is crossed.

Action levels only apply to the unavoidable or natural defect category. The FDA publishes all of the action levels in a guidance document . If the contaminant is not subject to an action level, the enforcement discretion will not apply. This includes blending a food product containing a substance in excess of an action level with another food product in an attempt to dilute the contaminant (FDA Guidance).¹¹ Action levels can also be found in Parts 109 and 509 of the CFR.

Examples of FDA Action Levels (FDA Guidance)¹²

Good Manufacturing Practices are the primary control to maintain minimum sanitary conditions in a facility. The Good Manufacturing Practices are published in 21 CFR 110 for food and 111 for dietary supplements . The GMPs outline all of the sanitation controls and methods for equipment, grounds, shipping, and facility. An entire GMP is dedicated to pest control, the most prevalent citation for insanitary conditions .

GMPs are important for many reasons. The obvious value in GMPs is providing a uniform safety net to ensure all food products are produced, stored, and shipped in a way that protects the integrity and wholesomeness of the food. GMPs are also important because the procedures serve as invisible link in the bond of trust between consumer and producer. A consumer cannot visit every food facility that makes the product in their cupboard. The global economy is about production occurring away from our homes and communities by a number of actors we trust but cannot see. Neither can consumers see the effects of that facility—the rats near finished product, the cockroaches near production lines, the mold on the floor or ceiling, and so on. GMPs when followed provide the public confidence that the facility their food originated at is a clean facility. This is often why GMP violations are prevalent in Form 483 .

Identifying and controlling hazards ensures food is safe. Hazards can include sanitation practices, but also a variety of issues unique to particular product or class of products. Soft cheeses, for example, are prone to contamination with Listeria or seafood, which requires refrigeration at specific temperatures. Failing to control facility-wide and product-specific standards allows potential hazards into a food product, including chemicals, physical hazards, and microbiological contamination.

FSMA fundamentally changes how hazards are controlled. Prior to FSMA, facilities could voluntarily adopt a HACCP plan, which aims at identifying and controlling hazards. Otherwise there was a risk of adulteration , but there was no enforcement or mechanism to ensure that hazards were controlled. FSMA changed the existing paradigm by introducing a new rule known as the Hazard Analysis Risk-Based Control Rule , or Preventative Controls rule . The Preventative Controls rule implements two changes. It revises the GMP regulations with minor tweaks and more importantly introduces a mandatory hazard control system.

The Preventative Controls rule essentially introduces a HACCP -esque system for qualifying food facilities. The rule varies from HACCP in key areas, but the overall aim is the same. The rule requires science and risk-based preventive controls as necessary to prevent hazard associated with a facility and its products. Not all facilities are subject to the rule with exemptions for small and very small facilities. There are also modified requirements for certain low-risk activities. A facility must identify only those hazards “reasonably likely” to occur. It is then given flexibility in what preventative controls are used, but the FDA will assess the adequacy of the control. Hazard identification and control will soon be a mandatory means for ensuring against indirect adulteration .

Intentional adulteration typically involves acts beyond a food facility’s or the FDA ’s control. Acts of terrorism or tampering with products in a grocery store require an interagency approach. The FDA and USDA coordinate with a long list of agencies on food defense, including the Center for Disease Control and Prevention (CDC ), the Department of Homeland Security (DHS ), the Federal Bureau of Investigation (FBI ), the Environmental Protection Agency (EPA ), the Department of Defense , the Department of Energy , the Department of Commerce , and the Department of the Interior . The coordination also envelops state, local, tribal, territorial, and private sector partners to develop food safety plans. The FDA for its part completed vulnerability assessments of a variety of products and processes within the food and agriculture sector along with developing several guidance documents for industry.

Prior to FSMA the main tool for the FDA to address intentional adulteration was through Guidance Documents. The FDA issued five Guidance Documents and launched a new ALERT system to assist industry in protecting the food supply against intentional adulteration . All five Guidance Documents were issued in 2003. Each Guidance Document addressed food security preventive measure for specific types of facilities. It includes guidance for producer, processors, and transporters, importers, milk industry, retail food stores, and food service establishments, and the cosmetic industry. The Guidance Documents outline best practices in food defense and preventative measures to reduce the risk of intentional adulteration. The Guidance Documents were updated most recently in 2007. The FDA also developed a number of training programs and resources for State and industry partners.

FSMA introduced a new rule to mandate preventative controls aimed at mitigating the risk of intentional adulteration . The rule requires facilities covered by the rule to develop Food Defense Plans . The FDA identified four key activities most vulnerable to intentional adulteration .