Health Claims on Food Labels

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 What Is Product Liability?

Product liability is the set of laws that hold a manufacturer, wholesaler, or seller of a product accountable for defective products in the stream of commerce. Under product liability laws, any party responsible for any part of the manufacture or sale of a defective product may be held liable for injuries that result from that defective product’s use.

For example, when creating a motor vehicle numerous different parties that are involved in the manufacture, distribution, and sale of the vehicle. One manufacturer may create the engine, another may create the vehicle’s body, while another may manufacture the tires.

All of the individually manufactured pieces would then be brought together and assembled by another company to make the final product. After the final product is complete, one party will then be in charge of distributing the vehicle to vehicle dealers, who will then sell the vehicle to a consumer.

Continuing the above example, if a completed vehicle is defective, then any of the following parties involved may be held liable for any resulting injuries:

  • The manufacturer that performed the assembly for the vehicle;
  • The wholesaler that received the completed vehicle and sold the vehicle to the distributor;
  • The dealer that sold the defective vehicle to the consumer; and/or
  • The manufacturer of the specific piece of the completed product that was found to be defective.

Once again, product liability law is its own distinct category of law. This means that product liability law differs from typical personal injury civil suits. Product liability laws are designed to protect and compensate consumers for their injuries, while also serving as a deterrent to manufacturers by punishing those responsible for defective goods.

What Are The Different Types Of Product Liability Claims?

As there is no federal law governing products liability cases, product liability lawsuits are based on state specific product liability laws. Product liability claims are typically brought under the legal theory of negligence, breach of warranty, or strict liability. Strict liability is the most commonly used legal theory utilized by plaintiffs in defective products cases.

The three legal theories that product liability claims are commonly defined as follows:

  • Negligence: In a negligence claim the defendant (i.e. the manufacturer, distributor, or seller) owes the plaintiff (i.e. the party that was injured) a duty of care to prevent unreasonable risks of harm and injuries when using their product. If that duty of care is then breached by the defendant, resulting in an injury to a user of their product, the defendant may then be held liable for the resulting damages;
  • Strict Liability: In a strict liability claim the plaintiff does not need to prove the negligent or reckless behavior of the defendant. Instead, if the product was defective and caused an injury, then liability against the defendant will automatically exist; and
  • Breach of Warranty: A warranty is a type of guarantee that is made by a seller of goods. A warranty may either be an express warranty or an implied warranty.
    • An express warranty is created by overt statements or actions by the seller of the goods. For example, if a seller makes an oral or written promise about how a product functions or the benefits of a product, then the product must conform to that specific function or result in said benefits;
    • An implied warranty is any warranty that is created by law. Implied warranties apply to products regardless of whether the seller made any sort of statements or promises. The most common implied warranties are the implied warranty of merchantability, and the implied warranty of fitness for particular use.

What Are Health Claims?

A health claim involves whether or not some type of consumable food or food component can affect a disease or health-related condition. In most cases a health claim can be found on a label of a product. A health claim on a product may state that the food is beneficial in helping to prevent or treat individuals that possess some kind of health condition.

For example, an orange juice container may include a printed health claim on it about how a certain number of servings of orange juice each day can help reduce the risk of heart disease. It is important to note that just because a food label states some health related benefit, does not automatically make that statement a health claim.

Health claims do not include a claim of general benefit to one’s health, but rather how the use of that product helps against a specific disease or other disorder. This means that a statement on a milk container saying “milk helps you build strong bones” would not be considered a health claim. However, if the statement on the milk carton said something about milk helping to reduce the risk of osteoporosis for individuals with a heightened risk of osteoporosis, such a statement would be considered a health claim.

Do Health Claims Have to Be Authorized by the FDA?

In short, yes. A health claim must be approved by the Food and Drug Administration (“FDA”) before the manufacturer is allowed to put the health claim on one of their food products. In general, there are two ways in which a manufacturer can obtain FDA approval:

  • Scientific Data and Evidence: The most common way in which a manufacturer can obtain FDA approval is through the presentation of scientific studies and evidence that confirm the health claims.
    • First, the manufacturer must submit an application for approval to the FDA that contains the scientific evidence of the health claim being accurate. Next, the FDA will then investigate the claim based on the evidence and decide whether the claim accurately portrays the evidence provided. Then, if the FDA feels the health claim is truthful and not misleading, they will allow the claim to be put on the product; or
  • Authoritative Statements: The second way in which a manufacturer may obtain approval for a health claim is to derive the claim from an “authoritative statement” made by a scientific body of the federal government or the National Academy of Sciences.
    • In these cases, the manufacturer merely has to notify the FDA of the claim and of the official governmental source from where it was derived, and the FDA will approve the health claim to be on the product, as long as the product contains that ingredient, etc.

What Should I Do if I Have Purchased and Consumed a Food Product That Has an Untruthful or Misleading Health Claim?

The first step is to submit a complaint to the manufacturer of the product, as well as open a complaint with the FDA. If the complainant does not result in your legal issues being resolved, you should then determine the party that may be held liable for your injuries.

Then, you can file a civil lawsuit based on either the breach of an express warranty, or other defective product legal theory against the responsible party. If successful, you may be entitled to damages that compensate you for your injuries and losses.

Do I Need a Lawyer for Help With Health Claims on Food Labels?

If you have been harmed by a product that contained a misleading health claim, it is in your best interests to consult with an experienced defective products attorney.

An experienced attorney will be able to help you determine whether or not you may hold the manufacturer or seller of the product liable for the harm you suffered. Additionally, an attorney will also be able to initiate a civil lawsuit against the responsible party. Finally, an attorney will also be able to represent you in court, as needed.


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