Playing Politics with Our Food: History of Food Regulations Starting with the United States Food and

<<This post is a continuation of previous posts. To read the introduction, click here.>>

Food safety is a multifaceted policy domain, which touches on a variety of issues and disciplines and consists of an important international dimension. International trade has greatly changed food production and consumption patterns in every country worldwide. Not only do food products themselves cross boarders, but also, a food product can be created in one country, with raw materials from multiple other countries, and exported for consumption to various countries across the globe.[1] Based on this expansive global roadmap for different food products, food safety regulations in one country can have a widespread effect on public health within a completely different country then where the product’s products were even grown. In addition, differing food regulations for a particular country can play a critical role as trade barriers, creating international tensions between countries. For this reason, knowing and understanding the differences in food safety policies per country is vital. We'll start with talking about the United States and the FDA's policies.

The United States Food and Drug Administration's Approach to Food Safety Legislation.

The United States, having a common law foundation, tends to be reactive when creating food safety legislation. Generally, regulations are emplaced as a response to problems that arise. The enactment of the U.S. Food and Drug Administration (FDA) itself is a prime example of the U.S.’ reactive as opposed to pro-active nature when dealing with food safety regulations. It wasn't until 1906, upon the publication of Upton Sinclair’s novel “The Jungle,” which concerned the dire conditions in the Chicago meat packaging industry, that President Theodor Roosevelt moved to create the FDA.

Since its enactment, the FDA did not contain strong instruments for enforcement, especially regarding processed food. The composition of many processed foods with the same name was often very different because no adequate provisions existed that clearly defined what processed foods should or should not be nor did standards exist for these food products. For that reason, unscrupulous producers could sell water or other adulterants as nutritious foods. Despite regular reminders about these problems by consumer advocates and health professionals, Congress did not enact a stronger law until 1938, when a pharmaceutical product was responsible for over 100 deaths[1]. Soon after, the Federal Food, Drug, and Cosmetic Act (FDCA) was enacted, which granted the FDA statutory authority to issue regulations that conform with the principles of the FDCA.[2]

Based on the examples above, the US has historically taken a more risk-benefit approach to food legislation, concentrating more on consumer choice and education than actual mandatory policies. Still, the FDA's mission is to protect the public health by assuring the safety, efficacy, and security of drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation.[3] Some responsibilities of the FDA include approving new food additives, safeguarding all ingredients used in food products, monitoring ingredients and foods to see that they are contaminate free, monitoring dietary supplements, infant formulas and medical foods, and overseeing food labeling, ensuring that the labels are informative, truthful, and useful to the consumer.[4]

To no surprise, although the FDA has the authority to issue regulations that have the force of law, the FDA has settled on informal regulations as its policymaking weapon of choice.[5] This was portrayed in the FDA’s 1994 mandate on the use of nutrition labels, which was created to ensure that each label display specific nutritional information of each food regardless of food claims on the product.[6] Though robustly employing their authority to mandate such informative labels, the FDA fails to require recalls on products that do not reach the labeling mandates standards and instead is more inclined to ask a manufacturer to undertake a voluntary recall; recommending, as opposed to mandating the removal of a particular product from the shelves.[7] This action displays FDA’s premises of a risk-benefit approach to policy implementation. Although the FDA does have the authority to seek legal action if a firm refuses to recall the product, it rarely does. [8]

In terms of inspecting food, imported products must comply with regulations applicable to products produced domestically; however, the FDA lacks a minimum inspection mandate.[9] Domestically, the FDA inspects less than one-forth of in-country food plants each year and relies heavily on voluntary measures for suppliers themselves to test the products.[10] The FDA inspects less than one percent of the food imported into the United States and only .2 percent of total food imports undergo laboratory analysis.[11] Though the FDA maintains a list of nominated establishments in which it recommends that importers source their products, it does not require the use of this list. Individual freedom to make your own decision regarding what you eat appears to be a central concept of the US’ regulatory values. How do you think this effects the implementation of Genetically Modified Foods in our diet? This buyer's beware approach to food safety seems rather ineffective as Jon Sinclair’s book, the Jungle, recognized in 1906 - most problems related to foods can not be detected by consumers using basic sense of sight, smell, taste, or touch when selecting or consuming food.

Do you think the EU will be more or less strict in terms of their food safety regulations? To read more about the European Union’s approach to Food Safety Regulations, click here.

[1] Praveen Gangahar, Food Safety and Management System, in Food Safety, Quality Assurance and Global Trade: Concerns and Strategies 25, 25 S.P. Singh et al. eds., 2009.

[1] U.S. Food and Drug Administration, Taste of Raspberries, Taste of Death The 1937 Elixir Sulfanilamide Incident, FDA Consumer magazine, June 1981 Issue (available at http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/)

[2] 52 Stat. 1040, as amended, 21 U.S.C. §§ 301 et seq. (1946). See Kleinfeld, Legislative History of the Federal Food, Drug, and Cosmetic Act, 1 Food Drug Cosmetic L.Q. 532 (1946).

[3] Food and Drug Administration, 21 U.S.C. § 393 (2006). The FDA shall] protect the public health by ensuring that ... there is [a] reasonable assurance of the safety and effectiveness of devices intended for human use[.] § 393(b)(1), (2)(B)-(C).

[4] See Federal Food and Drug and Cosmetic Act, 21 U.S.C. 301.

[5] K.M. Lewis, Informal Guidance, and the FDA, 66 Food & Drug L.J. 507, 508 (2011). This article traces the historical development of guidance at the FDA and evaluates whether this approach has been beneficial for the agency in regulating entities.

[6] Misbranded Food, 21 U.S.C.A. § 343(r)(1); New York State Restaurant Ass'n v. New York City Bd. of Health, 556 F.3d 114 (2d Cir. 2009).

[7] Food and Drug Administration, Department of Health and Human Services, 21 C.F.R. § 7.45(a); FDA, Regulatory Procedures Manual, Chapter 7-5-2, “FDA Requested Recall”, available at http:// www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074312.pdf

[8] Id.

[9] 21 U.S.C.A. § 381 (2011) (empowering the Secretary of Health and Human Services and, by extension, the FDA to enforce the same regulatory standards on prescription drug imports as on domestically produced prescription drugs); See also, FDA Div. of Field Investigations, Guide to International Inspections and Travel, § 302.1 (2002), available at http://www.fda.gov/ICECI/Inspections/ForeignInspections/ucm113565.htm#303.1 (“The intent of the international inspection program is to ensure that products manufactured in foreign countries meet the same standards of quality, purity, potency, safety, and efficacy as required of domestic manufacturers.”)

[10] Dept. of Health & Human Servs., Office of Inspector Gen., OEI-02-08-00080, FDA Inspections of Domestic Food Facilities (Apr. 2010), available at http://oig.hhs.gov/oei/reports/oei-02-08-00080.pdf.

[11] Fred Gale and Jean Buzby, Imports from China and Food Safety Issues, ERS Report Summary, US Dep. Of Agr. (July 2009), available at http://www.ers.usda.gov/media/156008/eib52_1_.pdf

#foodlegislation #foodsafety #fda #eu #china #internationaltrade