Herbs and their by products have been around for many centuries and have been traditionally used for their health benefits. Common examples of herbal products include ginkgo, chamomile, garlic and green tea. The herbal supplement market has been quite lucrative for manufacturing industries which advertise their products as promoting or supporting a healthier condition or disposition.
Herbal supplements are so named because they contain one or more herbal ingredients intended to promote or increase nutritional intake. Herbal products are sometimes referred to as botanical supplements as well.
The Federal Food, Drug and Cosmetic Act makes clear that herbal supplements are a category of dietary supplements, which themselves are a special subcategory of foods. Dietary supplements contain an ingredient such as a vitamin, enzymes, mineral, herb or other botanical.
Herbal supplements can be produced in a variety of forms, including tablets, capsules, gelcaps, powders, softgels and liquids. Current law, which includes the Dietary Supplement Health and Education Act, identifies dietary supplements as a special subset of foods (but not actually food, and thus subject to softer regulations than those for regular foods and medicinal drugs).
How are Herbal Supplements Different from Drugs?
The FDA requires that manufacturers, including herbal product manufacturers, follow certain production practices to prevent ingredient cross-contamination and product adulteration. In the case of herbal supplement manufacturers, it is the manufacturers themselves who are responsible for evaluating the safety and labeling of their herbal products before putting them into the marketplace. The FDA will take action after the product is on the market if there is some issue of safety or misbranding.
Where other products (i.e. drugs) under the oversight of the FDA must first be demonstrated to be safe and effective before they can be provided to consumers, dietary products can be placed in the market without providing the same requirements or assurances.
Prescribed drugs undergo rigorous clinical testing and scientific scrutiny before they can be approved by the FDA. As well, the FDA does not have to give its approval for a herbal product before the manufacturer can start selling them to consumers.
Herbal supplements are therefore generally proven unsafe only after they have caused harm to the consumer, whereas prescribed drugs must be proven safe before they can get into the hands of the consumer.
As well, because herbal supplements are differently regulated, manufacturers can make claims about their products that are not permitted for prescription drugs. For example, they can claim that their herbal products support or promote a certain condition or address a deficiency.
Nonetheless, herbal supplements still lead to legal issue for manufacturers which claim their products provide a cure for a disease, condition or illness. These health claims are subject to approval by the FDA.
What are Some Concerns About Herbal Supplements?
Consumers sometimes use herbal supplements to treat diseases or in lieu of eating complete meals. As well, consumers may suffer negative effects because they combine different supplements or combine supplements with prescription drugs.
In addition, taking too much of some supplements (such as vitamins) can have unwanted and serious side effects. You can avoid some of these negative side effects by letting your doctor and pharmacist know exactly what supplements you are taking.
Have There Been Claims For Damages Relating to Herbal Products?
Although the FDA regulations for herbal supplements aren’t as restrictive as for foods or drugs, if you have been injured because of a herbal supplement, the consumer may be entitled to file a product defect lawsuit against the manufacturers and other responsible parties (i.e. distributors and retailers).
For example, if a manufacturer fails to list an ingredient and the consumer is exposed to an allergen and falls ill as a result, the consumer may have a claim against the manufacturer. The claim is one that alleges the injury was caused by the improper labeling of the herbal supplement.
As another example, if a consumer takes a herbal supplement that claims to treat or cure heart disease and the consumer, believing these claims, takes the supplement but still suffers a heart attack, the consumer may have a claim against the manufacturer for these misleading claims.
If an allergen was contained in the herbal supplement because the manufacture failed to prevent cross-contamination and the consumer is injured, the consumer may also sue for a manufacturing defect.
The consumer may recover for injuries suffered if it can be established that the product had an unreasonable safety defect and the consumer was using the product as instructed. Consumers should be prepared to show they were unaware of the defect and that they followed the instructions and warnings on the product labels.
Do I Need a Lawyer for an Injury Related to an Herbal Supplement?
If you have been injured because you have taken a herbal supplement, you may file a lawsuit to recover for your injuries. A defective products lawyer can help you assess your case and help you pursue a vigorous claim against the responsible parties.