When a dietary supplement is adulterated, the supplement is considered to be unsafe or impure. The adulteration of male enhancement or other dietary supplements can occur in one of several ways. According to the Dietary Supplement Health Education Act (DSHEA) of 1994, adulteration can occur if the supplement has an unreasonable risk of injury or illness when a person uses the supplement pursuant to the instructions on the label. Another reason for adulteration is if the product contains a quantity of a substance that is sufficient to cause the supplement to be harmful or poisonous.
Adulteration has also been defined as the contamination of a supplement by adding a component that is inferior or impure or removal of a critical component. Contamination can be intentional or unintentional. Adulteration can occur during the manufacturing process if a company is not in compliance with the FDA’s Good Manufacturing Practices. When a company does not have controls in place to ensure that a product meets quality standards, the supplements can be unsafe, impure, or ineffective.
Intentional Adulteration of Dietary Supplements
In some cases, a company will intentionally adulterate a dietary supplement to make the supplement fulfill the claims and advertisement. For example, introducing certain agents such as caffeine, benzodiazepines, nonsteroidal anti-inflammatory agents, and corticosteroids to a supplement can make the consumer believe the supplement is working because they “feel” better. However, the company does not report it has intentionally added these adulterants. If the supplement is labeled as “all natural,” but it contains these substances, the person may use the supplement and have an adverse reaction because of the adulterant.
Contamination-Related Adulterants
This type of adulterant includes several different sources of adulterants. A supplement can be contaminated by biological debris such as microbes or insects, or because an undesirable portion of a plant was used when making the supplement. As discussed above, an intentional addition of drugs can adulterate a dietary supplement. Minerals added either by mistake or deliberately can also contaminate the product, making it unsafe to use.
Liability for Product Adulteration
When a product is contaminated or adulterated, a manufacturer, distributor, or retailer could be held liable for any damages resulting from the adulteration. When consumers purchase a dietary supplement, such as a male enhancement supplement, they have the right to rely on the label to provide a detailed and complete list of all ingredients. Failure to label male enhancement supplements properly or adhere to the FDA's guidance for manufacturing dietary supplements can result in severe injury to consumers.