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U.S. Department of Health and Human Services

For Consumers

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FDA's Standards for High Quality Foods

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box of assorted chocolates

No matter what you pick from a box of assorted chocolates, you can be assured that FDA standards ensure the highest quality.

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In recent months, several newspapers came out in defense of a new cause: the quality of chocolate. "Hands off my chocolate, FDA!" read one headline. Another said "Chocoholics Unite!"

The heated outcry—echoed in hundreds of letters FDA has received from consumers—was sparked by concerns about some of FDA's oldest and most trusted regulations: rules ensuring that America's favorite food products have the right amount of key ingredients, are properly made, and are not packaged in containers of deceiving size. These so-called "standards of identity, quality, and fill of container for food" have been a trusted barrier against substandard and fraudulently packaged food since their enactment in the 1938 Food, Drug and Cosmetic Act. Last fall, when a trade association petitioned the agency to make some of these standards more flexible, it therefore touched a raw nerve.

Another headline explained the concerns of chocolate enthusiasts this way: "Chocolate Purists Alarmed by Proposal to Fudge Standards."

FDA's Standards

But consumers can be sure that FDA's food standards, which by now include almost 300 products, are and will remain sound. Originally, these requirements were set forth to protect consumers from contaminated products and economic fraud. Later, the standards were also used to improve nutrition.

The hallmark of most of these regulations has been their attention to details that include not only each product's name and mandatory and optional ingredients, but in many cases also the minimum levels of valuable constituents and the manufacturing process.

The standards for canned cherries, for example, specify that "not more than 15 percent by count of the cherries in the container are blemished with scab, hail injury, discoloration, scar tissue or other abnormality. A cherry showing skin discoloration (other than scald) having an aggregate area exceeding that of a circle of 9/32 inch in diameter is considered to be blemished."

Evaporated milk, another typical product, has to "contain not less than 6.5 percent by weight of milkfat, not less than 16.5 percent by weight of milk solids not fat, and not less than 23 percent by weight of total milk solids." The canned tuna standard takes up eight pages of small print in the Code of Federal Regulation, and includes such detail as the thickness and diameter of the plungers used for filling the product into three different sizes of cans.

Upheld by the courts and supported by food companies, the rigor of these standards in the early years served their purpose well. Consumers benefited from the improved and dependable quality of many food staples, and manufacturers appreciated the level playing field where competitors could not cut prices by selling inferior products. The biggest gains were scored by the public health. In the 1940s and early 1950s, the standards for enriched food products helped eliminate such once-widespread nutritional deficiency diseases as pellagra. More recently, the FDA-required addition of folic acid to most breads and other grain products has addressed the risk of neural tube defects, such as spina bifida.

New Problems

In time, however, the minutely defined standards revealed two flaws. One of them was the unwieldy and time-consuming standard-making process, which encouraged excessive input by supporters and opponents of the proposed recipes. For example, it took from 1941 until 1950 to develop the standard for white bread. The problem persisted until 1953, when Congress waved the requirement of hearings on certain types of food issues.

The other difficulty was the very rigor for which the standards were famous. The problem began emerging in the mid-1950s, when advances in manufacturing technology made possible the introduction of refrigerated, frozen and other ready-to-eat foods. To allow these products on the market, FDA has experimented with less restrictive manufacturing requirements, and in the last two decades it has modified some standards to facilitate the development of low-fat and low-calorie products.

But despite these adjustments to new consumer demands and conditions, some of the food standards became increasingly incompatible with advanced food-making technology, as well as international food standards. These new challenges called for a thorough modernization of FDA food standards.

Proposed Principles

In 1995, FDA asked stakeholders what alternatives it should adopt to the existing safeguards. The responses made clear that while food standards were strongly supported by both consumers and industry, there was an equally strong desire that they be simplified, clarified, and made more flexible.

Based on these comments, FDA and the Food Safety Inspection Service of the U.S. Department of Agriculture (USDA) developed a joint approach to the formulation of food standards. USDA is the agency that regulates meat and poultry. In May 2005, the two agencies proposed 16 broad principles that, if adopted, would assist food firms in seeking to establish, amend or revoke food standards.

The proposed fundamentals are primarily focused on how the food requirements should be written and what they should incorporate. Under the key proposals, the standards would:

  • describe the basic nature of the food and reflect its essential characteristics
  • ensure fair dealing by making sure the food does not appear to be better or of a greater value than it is
  • facilitate the manufacture of food and promote flexibility in food technology by containing clear and easily understood manufacturing requirements, and providing for any suitable alternative processes that accomplish the desired effect
  • be simple, easy to use, and consistent among all food standards
  • authorize descriptive terms for the food that could be used in any order that is not misleading to consumers.

FDA is analyzing comments submitted on these proposals. But chocolate lovers need not be alarmed about the future of their favorite product: As has been the case since the passage of the Food, Drug and Cosmetic Act of 1938, FDA's food standards will continue meeting their statutory purpose, which is "to promote honesty and fair dealing in the interest of consumers."

Cacao fat, as one of the signature characteristics of the product, will remain a principal component of standardized chocolate.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: June 18, 2007