Supermarkets carry an average of more than 38,000 different items on their shelves. The Pew Charitable Trusts’ Food Additives Project estimates that there are more than 10,000 chemicals allowed in food that help make this variety possible. These chemicals perform many functions, including enhancing the taste or appearance of food, preventing spoilage, and packaging the products.
Related: More resources from the food additives initiative
Our modern food supply and production systems have grown increasingly complex since the 1950s with the enactment of the Food Additives Amendment of 1958. The law was intended to ensure that chemicals added to our food were safe; however, Congress also created an exception for food ingredients that had been commonly used for decades and did not, it was believed at the time, need to be thoroughly tested. Industry was given the authority to declare these ingredients, such as olive oil and vinegar, to be “generally recognized as safe” (GRAS). Manufacturers today have moved well beyond the law’s original intent and regularly use the GRAS process to declare the vast majority of new additives safe, rather than submitting them for the U.S. Food and Drug Administration’s (FDA) approval. What was intended as an exception has now become the de facto rule.
The complexity of our food supply and the oversight of its safety raise fundamental questions about what we eat — some of which were answered for the first time in "Navigating the U.S. Food Additive Regulatory Program," an analysis undertaken by Pew and published in the peer-reviewed journal, Comprehensive Reviews in Food Science and Food Safety.
The following "frequently asked questions" summarize the findings and conclusions of this article.
According to Congress and FDA, "food" includes but is not limited to: human food; pet food; animal feed; chewing gum; components of any of those items; and chemicals that migrate to food from packaging, housewares, and food handling equipment. Under this definition, a food additive is food.
In short, it’s complicated.
"Food additive" is a legal term. It is one of seven categories of substances that Congress established and that end up in our food supply. The other six are:
- Color additives
- Drugs in animal feed
- Dietary supplements
- Prior-sanctioned substances (i.e., chemicals that were government-approved for use in food before Congress passed the Food Additives Amendment of 1958)
- Chemicals that are “generally recognized as safe,” or GRAS.
A "food additive" is a substance that doesn’t fit into any of the six categories, but is reasonably expected to become a component — or affect the characteristics — of a food (including substances used in producing, manufacturing, packing, processing, preparing, treating, transporting or holding food). FDA is required to assess the safety of food additives before they are used in food.
Some of these substances are intentionally added to our food. Others are allowed to be in our food because they end up there unintentionally when they migrate from processing equipment or packaging.
Overall, Pew estimates that more than 10,000 substances are allowed in human food. Manufacturers or trade association panels approved more than 3,000 of these chemicals without any FDA review. Of those, Pew estimates that about 1,000 chemicals are entirely unknown to FDA and the public. An informal survey of food industry experts confirmed this estimate; many suggested the figure could be significantly higher.
FDA is the primary federal agency that regulates chemicals added to our food, including food additives, color additives, and drugs used in animal feed. The U.S. Environmental Protection Agency (EPA) oversees, with FDA’s support, pesticides used on our food.
See also the reply to question 2.
Yes, there are restrictions. A safety determination is required before a chemical can be allowed in our food. However, a company can make its own determination that a chemical is generally recognized as safe and clear it for use without notifying FDA or the public.
For food additives, GRAS substances, and color additives to be found safe, they must, at a minimum, meet the following requirements:
- Competent scientists must be reasonably certain that the chemicals are not harmful when used as intended (though FDA does not define “competent scientists” or “harm”); and
- The substances must not induce cancer in animals or humans.
The safety of a food additive is also contingent upon a company not using any more of the chemical than is necessary to achieve the intended purpose.
NOTE: Pesticides, drugs in animal feed, dietary supplements, and prior-sanctioned substances are subject to different standards.
There are three ways a food manufacturer can get clearance to add a chemical to its products:
- Self-determination: In 1958, Congress allowed a manufacturer or trade association to decide on its own that a chemical’s use is generally recognized as safe. This determination should be based on the opinion of experts in the field using published studies. Neither FDA nor the public are involved in the safety decision, and they do not necessarily know about the chemical and in which foods it is used.
- Petition: FDA approves the use of a chemical by issuing a new or amended regulation. The agency usually makes this safety decision in response to a petition by a manufacturer or its representative and provides the public with the opportunity to comment before the chemical is approved. Before 1995, FDA conducted all of its food additive reviews this way, but from 2006 to 2010, this process accounted for less than three percent of the agency’s reviews. For color additives, a petition is the only option.
- Notification: A manufacturer asks FDA to review its safety decision for a chemical use. If the agency’s review raises no concerns, FDA sends a letter stating that it has "no objections" or "no questions" to the manufacturer’s decision without any opportunity for public comment. If the agency raises concerns, a manufacturer may withdraw its notification without penalty but is still able to use the chemical via the self-determination process. FDA instituted the expedited notification approach in the late 1990s. From 2006 to 2010, more than 97 percent of the chemicals were cleared using this method.
Manufacturers sometimes choose to seek FDA review rather than pursue self-determination because the agency’s no-objection or no-question letter helps with product promotion. Companies have been known to market the letter as FDA approval, even though the agency maintains that it is not.
Yes, it presents two chief concerns.
- If FDA is not aware of a chemical being used in our food, it cannot ensure that company used sound science to evaluate its safety.
- Unlike FDA, an industry scientist may have a conflict between the company’s economic interest in getting a new product to market and its responsibility to ensure that its customers are safe.
Additionally, many chemicals used in food are not required to be listed on a product’s label to avoid overwhelming consumers. This means that often times we do not know what chemicals we are eating.
10. What is the public’s role in determining the safety of chemicals in food?
Since 1996, the public has had a limited to nonexistent role in almost all of FDA’s safety reviews because notifications constitute the bulk of them; these programs eliminate the requirement for public notices and comment.
For notifications for substances that are used as a component in the manufacturing, packaging, or packing of food, FDA posts on its website any decisions it makes to allow them to be used (or chemicals it has not objected to). The agency describes the chemical, limitations for its use, and the name of the manufacturer who has submitted it. FDA does not post the manufacturer’s notification or the contents of the agency’s letter to the manufacturer.
For GRAS substance notifications, FDA publishes on its website the manufacturer’s notice and the contents of its letter to the manufacturer including any limitations on use.
Although the notification programs have been successful in reducing the need for chemical-by-chemical rulemaking, they have made it more difficult for the public to access the information necessary to understand the basis for safety decisions and provide comments on those decisions before FDA acts.
Pew believes when a federal agency receives comments from competitors, outside scientists, public interest groups, and the general public, its decisions are likely to be better informed and may be expected to better protect consumers.
When Congress established the food additive regulatory program in 1958, lawmakers focused on ensuring a chemical was safe prior to use and did not require FDA to regularly review chemicals added to food after their initial approval. As a result, FDA only reassesses past decisions on a case-by-case basis, usually in response to petitions from industry or public interest organizations.
The last and only systematic review of chemicals added to food was ordered by President Richard M. Nixon in 1969 and covered just a few hundred chemicals. This review ended in the early 1980s. The agency has not acted on 18 of the chemicals where concerns were raised.
Even if new evidence emerges that suggests a chemical in use could harm consumers, FDA has difficulty requiring industry to conduct tests on potential risks. In addition, food manufacturers are generally not required to alert FDA to new studies that raise questions about a chemical’s safety. Because approvals in regulations are effectively permanent, manufacturers have no incentive to conduct post-market studies using more advanced scientific methods to ensure that their chemicals can still be considered safe. They must only report adverse health effects in cases of death and serious harm, the latter of which FDA has not defined. On the whole, these limited reporting requirements make it difficult for FDA to ensure that chemicals may not cause long-term harm to people.
FDA’s process for reviewing the safety of food additives has changed significantly over time, with the largest shift taking place during the past two decades. The petition process established by Congress in 1958 proved cumbersome for FDA and manufacturers because of backlogs at the agency, so FDA developed the notification option in the late 1990s.
One outcome of this shift has been reduced public understanding and involvement in the FDA process. For the notification option, FDA provides no opportunity for public comment to inform its review. In the case of food contact substances, Congress explicitly prohibits FDA from telling the public that it has received the notice or from sharing it with the public before it issues a no-objection letter. The agency’s decision and original notice are available only after the fact through a Freedom of Information Act request—a time-consuming process.
In the FDA Food Safety Modernization Act of 2011, Congress directed FDA to adopt rules requiring most food manufacturers and importers to: (1) confirm that the chemicals they are using, manufacturing, or importing are approved for use in food; and (2) prevent unapproved uses.
These reforms will help strengthen our food supply, but the generally-recognized-as-safe exemption will not allow FDA to fully realize the law’s intent. The agency can only ensure that companies comply with the law if it knows: (1) the identity and amounts of chemicals to which consumers are exposed; (2) new research on hazards associated with chemicals; and (3) whether consumers are experiencing health problems. Unfortunately, Congress neither required manufacturers to provide nor empowered FDA to collect such data.
On Wednesday, August 7, 2013, the Food Additives Project at The Pew Charitable Trusts hosted a multi-stakeholder workshop that discussed approaches to managing these conflicts of interest. The workshop was meant to explain the concerns that have been raised regarding the potential for COI in GRAS selfdeterminations, and identify and discuss approaches to resolving those concerns.More info
The peer-reviewed journal Reproductive Toxicology published a paper from The Pew Charitable Trusts' food additives project examining the data used to make safety recommendations for chemicals added to food sold in the United States. The analysis of three major sources of toxicology information found significant gaps in the data for chemicals that are added to food and food packaging.More info
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Sarah Kavanagh and her little brother were looking forward to the bottles of Gatorade they had put in the refrigerator after playing outdoors one hot, humid afternoon last month in Hattiesburg, Miss. But before she took a sip, Sarah, a dedicated vegetarian, did what she often does and checked the label to make sure no animal products were in the drink. One ingredient, brominated vegetable oil, caught her eye.More info
"Grocery shoppers examining colorful packages bearing long lists of hard-to-pronounce ingredients might take comfort in the belief that those substances were deemed safe by the government. But that's not the case. Over the past 15 years, the vast majority of new ingredients added to U.S. food never received a safety determination from the government."More info