What Laws Govern Nutritional Supplement Labels?
There are laws that govern nutritional supplement labels, including the Dietary Supplement and Education Act of 1994, the Nutrition Labeling and Education Act of 1990, and the federal Food, Drug, and Cosmetic Act.
Dietary Supplement and Education Act of 1994
This law defines dietary supplements and provides specific labeling rules and legal labeling requirements. It also outlines safety and adverse event guidelines.
Nutrition Labeling and Education Act of 1990
This law requires the majority of foods and dietary supplements to have nutrition labels. It also regulates health claims. Under herbal law, herbal supplements must also have the same required labels as other dietary supplements.
Food, Drug, and Cosmetic Act
This law provides the United States Food and Drug Administration (FDA) with the authority to regulate food safety as well as to prohibit adulterated or misbranded products in commerce.
FDA Label Requirements for Dietary Supplements
For FDA regulation of dietary supplements, there are also five main requirements for labels provided by the FDA, which include:
- A statement of identity, or the name of the supplement
- The net quantity of contents, or how much product is in the container
- Nutrition labeling, or the supplement facts panel that shows the serving size, servings per container, and dietary ingredients
- An ingredient list that shows all of the ingredients
- Business information, including the name and address of the manufacturer, distributor, or packer
What Is the Difference Between a Nutritional Label and a Supplement Label?
The difference between a nutritional label and a supplement label is that a nutritional facts label is typically found on conventional food and is focused on fats, calories, and carbohydrates. A supplement facts label, in contrast, is used on dietary supplements and is focused on minerals, vitamins, and active compounds.
Both types of panels are regulated by the FDA, but there are differences in what information is displayed in both. A single product cannot have both types of labels.
What Are Some Common Legal Issues with Nutritional Supplement Labels?
There are some common legal issues that arise related to nutritional supplement labels, including false advertising, product discrepancies, such as incorrect ingredients or dosages, and errors on the label panel.
Nutritional supplements cannot make false, misleading, or illegal claims. They cannot claim to diagnose, cure, treat, or prevent any disease.
Supplements cannot claim specific health benefits without proper scientific backing. In addition, supplements must have a statement on the label stating that any claims made have not been evaluated by the FDA.
Product discrepancies, such as incorrect ingredients or dosages, can cause serious issues for consumers. If discrepancies are found between the ingredients on the label and the contents of the actual product via testing, the product may face liability for misbranding and adulteration.
If there are errors on the label panel, issues can also arise. For example, displaying a nutrition facts panel instead of a supplement facts panel violates compliance regulations, including trans fat labeling.
The serving sizes have to follow the exact weights, as incorrect baseline serving sizes can invalidate all of the nutrient calculations provided on the label. If a supplement does not list all ingredient names or list all ingredients in descending order by weight, it can face regulatory issues.
What Are the Dangers Associated with Nutritional Supplement Label Errors or Fraud?
If there are nutritional supplement label errors or fraud, it can result in severe health complications, allergic reactions, and interactions with prescription medications. If products are misrepresented, they may contain pesticides, banned substances in dietary supplements, or heavy metals.
If there are high doses of mislabeled or omitted minerals or vitamins, it may result in kidney or liver issues over time. Products that do not list all ingredients, such as soy, gluten, milk, or nuts, may provoke severe allergic reactions.
Some unlisted ingredients can have interactions with prescription medications, for example, blood thinners, and cause life-threatening bleeding. If the ingredients are not properly labeled, it may result in under-dosing and not receiving the advertised benefits, or over-dosing and harming one’s system.
What Are Some Common Injuries Associated with Nutritional Supplement Labels?
There are several common types of injuries that are associated with nutritional supplement labels when issues occur, such as misleading information, omissions, and label inaccuracies. One common example of label-related injuries is in the category of bodybuilding and weight-loss formulas.
These types of products will sometimes include hidden anabolic steroids or prescription drugs that are not shown on the label. These drugs can cause chest pain, elevated heart rate, acute liver injury, and severe cardiovascular stress.
Another common example is miscalculated or hidden dosages in vitamins or sleep aids, for example, fat-soluble vitamins or melatonin that are stronger than the label indicates. These may result in organ strain, vitamin toxicity, and excessive drowsiness.
What if I Have Been Injured Due to a Nutritional Supplement Label Issue?
If an individual has been injured because of a nutritional supplement label issue, they should seek medical care immediately, save all of the product packaging, and report the event to the federal authorities. It is important to seek medical attention immediately to treat any symptoms and create an official medical record.
An individual should keep the bottle the product came in, its packaging, and any remaining product. When possible, they should also record where the product was purchased and when it was taken.
An individual should notify the FDA of their reaction through the online FDA Safety Reporting Portal. They should also consult with a local attorney to find out their legal options for holding the supplement maker responsible and for obtaining compensation for any injuries or losses they suffered, such as a potential food label lawsuit.
What Are the Legal Consequences for Manufacturers or Distributors?
Both manufacturers and distributors can face severe legal consequences for nutritional supplement label issues when their products violate safety standards or cause injury. These may include multi-million-dollar lawsuits and substantial regulatory civil penalties.
If a product caused consumers injury or property damage, a manufacturer, including herbal supplement manufacturers, and a seller may be liable. If a company does not provide proper usage instructions or clear safety warning labels on products, it can face liability.
A lawyer can explain the potential liability issues in an individual’s unique situation as well as assess the parties who may be held liable.
How Can an Attorney Help Me if I’ve Been Injured?
An attorney can help an individual who has been injured by a nutritional supplement label issue by helping them pursue compensation for their injuries and losses. A lawyer can evaluate the claim and work with experts, such as toxicologists, to establish causation between the mislabeled or defective supplement and the individual’s injury.
A lawyer will also be able to review the supply chain to determine what parties can face liability, such as suppliers of raw ingredients, manufacturers, distributors, and retailers. An attorney will pursue available claims, such as manufacturing defects and deceptive marketing under both state and federal protection laws, when possible. They will seek economic and non-economic damages to cover past and future medical bills, pain and suffering, and lost wages.
Should I Hire a Lawyer for Help with a Nutritional Supplement Label Issue?
Yes, it is very important to have a lawyer’s assistance if you have been injured due to a supplement label issue, as these cases can be very complex. A class action lawyer will be able to review your case, the injuries you suffered, and help you obtain the compensation you are entitled to for your losses.
