Herbs and herbal byproducts have been used by humans for many centuries for their health benefits. Examples of common herbal products individuals may be familiar with includes:
- Garlic; and
- Green tea.
The market for herbal supplements has been very lucrative for the manufacturing industry which advertises these products as supporting or promoting a healthier disposition or condition. An herbal supplement is named as such because it contains one or more herbal ingredients that are intended to increase or promote nutritional intake.
An herbal product is also sometimes referred to as a botanical supplement. The Federal Food, Drug and Cosmetic Act provides that herbal supplements are a subcategory of dietary supplements.
Dietary supplements themselves are a special subcategory of foods. A dietary supplement may contain ingredients, including:
- Herbs; or
- Other botanicals.
An herbal supplement may be produced in a variety of forms, including:
- Softgels; and
The current laws governing herbal supplements include the Dietary Supplement Health and Education Act which identifies dietary supplements as a special subset of foods but not actual food, and, therefore, is subject to softer regulations than those for regular foods and medicinal drugs. The Federal Drug Administration (FDA) may remove an herbal supplement from the consumer market if it is deemed unsafe or is misbranded, meaning it is mislabeled or misleading.
What is the Dietary Supplement and Education Act of 1994?
The Dietary Supplement and Education Act of 1994 (DSEA) provides that any substance, other than tobacco, which contains a vitamin, a botanical, an amino acid, or any combination of those ingredients which is used as a substitute for food is a dietary supplement. These substances typically come in the form of a pill, tablet, or liquid, for example, herbal supplements and energy drinks, and must be labeled on the front panel as a dietary supplement.
What are the Nutritional Labeling Requirements for a Dietary Supplement?
There are some nutritional labeling requirements for dietary supplements including their ingredients and nutritional content. A dietary supplement, for example, DMAA or Arbonne, is required to list:
- All of its ingredients;
- The amount of each individual ingredient; and
- The amount of all the ingredients put together.
If any type of botanical is used as an ingredient, the label is required to provide what portion of the plant it comes from. The dietary supplement must also list the significant amounts of dietary ingredients for which the FDA provides daily consumption recommendations.
Following these lists, the dietary supplement should also provide a listing of the dietary ingredients of which there are significant amounts but for which the FDA does not provide any daily consumption recommendations. The list of dietary ingredients in the nutrition facts section should also provide the quantity per serving of each ingredient.
How are Herbal Supplements Different from Drugs?
The FDA requires that all manufacturers, including those that manufacture herbal products, follow certain production practices in order to prevent cross-contamination of ingredients as well as product adulteration. For herbal supplement manufacturers, the manufacturer itself is responsible for evaluating the safety and labeling of the herbal products they produce before placing them into the consumer marketplace.
The FDA may take action after a product is already placed on the market if there is an issue related to safety or misbranding. This is different from other types of products, including drugs, which must be demonstrated as safe and effective to the FDA prior to being provided to the public consumers.
Dietary products, in contrast, may be placed on the market without providing these types of requirements of assurances. Drugs which are prescribed will undergo rigorous clinical testing as well as scientific scrutiny prior to being approved by the FDA.
In addition, the FDA is not required to give its approval to an herbal product manufacturer before it is permitted to start selling the product to consumers. In addition, because herbal supplements are regulated differently than drugs, manufacturers may be able to make claims about their products which are not permitted for prescription drugs.
For example, a manufacturer may claim that their herbal products promote or support a certain condition or address a certain deficiency. It is important to note, however, that herbal supplements may still lead to a legal issue if a manufacturer claims that their products provide cures for:
- A disease;
- A condition; or
- An illness.
These types of health claims are subject to approval by the FDA.
What are Some Concerns About Herbal Supplements?
A consumer may use an herbal supplement to treat a disease or in lieu of consuming a complete meal. A consumer may suffer some negative effects due to combining different supplements or combining supplements with a prescription drug.
In addition, if an individual takes too much of a supplement, such as a vitamin, it may result in unwanted and serious side effects. An individual can avoid these types of negative side effects by informing their doctor and pharmacist of exactly which supplements they are taking.
Have There Been Claims for Damages Relating to Herbal Products?
Yes, it may be possible to make a claim for damages related to an herbal product. Although the regulations provided by the FDA for herbal supplements are not as restrictive as those for drugs or food, a consumer may still be able to file a defective product lawsuit against a manufacturer and other responsible parties, including distributors and retailers.
For example, if the manufacturer of an herbal product fails to list an ingredient and, as a result, a consumer is exposed to an allergen and becomes ill, that consumer may have a claim against the manufacturer. This claim would be one which alleges that the consumer’s injury was caused by improper labeling of the herbal supplement.
Another example may include a situation where the consumer takes an herbal supplement which claims to treat or cure heart disease and the consumer, who believes those claims, takes the supplement but suffers a heart attack. In this case, the consumer may have a claim against the manufacturer for these misleading claims.
If there was an allergen in the herbal supplement due to the failure of the manufacturer to prevent cross-contamination and the consumer is injured, that consumer may also sue for a manufacturing defect. A consumer may be able to recover for injuries they incurred if they are able to show that the product had an unreasonable safety defect and that the consumer used the product as instructed.
The consumer should be prepared to demonstrate that they were unaware of the defect and that they followed all instructions and warnings on the product label.
Do I Need a Lawyer for an Injury Related to an Herbal Supplement?
If you have been injured as a result of taking an herbal supplement, you may be able to file a lawsuit and receive compensation for your injuries. It is important to consult with a defective products lawyer as soon as you discover an injury.
Your lawyer will be able to help you assess your case and help you pursue a vigorous claim against the parties who are responsible for your injuries. These types of claims may be complex and it may be difficult to prove that it was actually the supplement which caused the injury, especially if you have another underlying condition, for example, high blood pressure or diabetes.
Your attorney will be aware of these issues and how to best present your case in court.