Requirements for product warning labels

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Product warning labels are required by several different enforcement agencies. For some products, like medicine or cigarettes, warning labels are mandated by the government or by the Food and Drug Administration. For other products, the impetus for the warning label comes from tort law. Tort law is civil law--the branch of law that allows people to sue individuals or companies for harm or damages. Under tort law, if a product is potentially dangerous, the manufacturer has a "duty to warn" and that duty imposes the requirement of a warning label. The specific information and the type of warning label varies, depending on who or what is mandating the placement of the product warning label.


The FDA requires that medicines carry warning labels that alert consumers to the risks of side affects. The adverse reactions section of a drug label is required to list adverse reactions that can occur both with the specific drug, and with the particular class of drugs. A "class of drugs" includes all drugs with the same active and chemically-related properties. Separate warning lists are required to list side affects identified in clinical trials and side affects identified from consumer reports after a product has been released.

In August of 2008, the FDA issued a new rule aimed to ensure that warning labels provide clear and concise information to drug users. Under the new regulation, pharmaceutical companies must promptly and immediately release safety updates if and when there is evidence of a new risk to a drug not identified by previous FDA clinical trials.

The FDA mandates that there be separate sections on the label for warnings and precautions, contraindications and adverse reactions. Furthermore, there must be a boxed warning section if certain conditions apply. The boxed warning section should list all serious reactions, including the most commonly occurring adverse reaction (those occurring in 10 per cent or more of the treatment group). The boxed warning section must also list adverse reactions that result from discontinuing or changing the dosage of the drug.


The Federal Trade Commission mandates that each pack of cigarettes contain a "Surgeon General's Warning." The Warning, at a minimum, must state that "Cigarette Smoke Contains Carbon Monoxide."

There are no requirements regarding font, type or prominence of the warning label. Most warning labels are relatively small and blend in with the packaging on cigarettes.

Duty to Warn

On many other products, the requirement for a warning label stems from a duty to warn. Whenever a product carries with it a hazard or a risk, the manufacturers have a series of obligations imposed by tort law and by the American National Standards Institute. ANSI Z535 series, Safety Signs and Colors dictates the requirements for warning labels on products in the United States.

When possible, manufacturers must eliminate hazards in the design of products. When this is not possible, the risk of harm must be minimised by other protective measures, including guarding or limiting measures on the product.

When the product is as safe as possible, given its intended use and design, any remaining hazards must be addressed by the use of a warning label. The warning label should inform consumers of any training, procedures or protective equipment a person can use to minimise the potential for harm.

The warning labels should also dictate the specific types of harm the product carries with it.

ANSI Requirements

ANSI states that the warning must be "adequate." There are no specific guidelines on what constitutes an "adequate" warning. The courts have set forth general guidelines. In general, a panel should be placed on the product that contains language conveying the hazard, the potential consequences of the risk and steps or measures the user can take to avoid the potential hazard.

Product warning labels do not need to specify self-explanatory or obvious hazards. For example, the result of encountering an electrocution hazard is electrocution.

Many companies go beyond the ANSI requirements, dictating even obvious potential hazards on their warning labels to avoid potential civil liability. In other words, obvious hazards are spelt out so that a consumer can't sue the company for injury incurred from an obvious hazard associated with a product.

Safety Alert Symbols

ANSI also has established specific pictorial safety alert symbols. Unlike in Europe, where the pictorial safety alert often comprises the entire warning label, the pictorial alert is optional on U.S. product labels.

There are three different levels of safety alerts: danger, warning and caution. Each signal word has a symbol associated with it. The pictorial image can represent the hazard, the hazardous situations or the risks associated with not avoiding the hazard.

One well-known ANSI pictorial symbol is a lightning bolt, which signifies the product is electrical and can be dangerous if electrical hazards are not avoided. A white triangle set inside a red square, with a red exclamation point inside the triangle, is the ANSI symbol for "Danger." A yellow triangle with a black exclamation point in the centre is the ANSI symbol for "Caution."

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