Herbs and herbal byproducts have been around for many centuries. They have traditionally been used for their health benefits.
There are numerous common examples of herbal products, which include:
- Ginkgo;
- Chamomile;
- Garlic; and
- Green tea.
The market for herbal supplements has been lucrative for manufacturing industries that advertise their products as promoting or supporting health conditions or dispositions for users. An herbal supplement is named as such due to the fact that they contain one or more herbal ingredients which are intended to promote or increase nutritional intake.
An herbal product may also be referred to as a botanical supplement. The Federal Food, Drug, and Cosmetic Act provides that an herbal supplement is a subcategory of dietary supplements.
Dietary supplements themselves are a subcategory of foods. A dietary supplement main contain an ingredient such as:
- A vitamin;
- An enzyme;
- A mineral;
- An herb; or
- Another botanical.
An herbal supplement may be produced in numerous forms, which include:
- Tablets;
- Capsules;
- Gelcaps;
- Powders;
- Softgels; and
- Liquids.
Current laws, including the Dietary Supplement Health and Education Act, identifies a dietary supplement as a special subset of foods but is not actually good and, therefore, is subject to softer regulations than those regulations for regular food and medicinal drugs. If an herbal supplement is deemed unsafe or misbranded, such as being mislabeled or misleading, the Federal Drug Administration may remove it from the market.
How are Herbal Supplements Different from Drugs?
The FDA requires a manufacturer, including manufacturers of herbal products, to follow specific production practices to prevent product adulteration and ingredient cross-contamination. With herbal supplement manufacturers, the manufacturer itself is responsible for evaluating the safety and labeling of their herbal product prior to placing them in the marketplace.
The FDA will take action if, after a product is on the market, an issue regarding safety or misbranding appears. This is distinct from other products, such as drugs, which fall under the oversight of the FDA and must first be demonstrated to be safe and effective prior to being placed in the consumer market.
Dietary products, on the other hand, may be placed in the market without the same assurances or requirements. Drugs that are prescribed are required to undergo rigorous clinical testing and scrutiny prior to obtaining FDA approval.
The FDA is not required to provide its approval for an herbal product prior to a manufacturer selling them to consumers. An herbal supplement, therefore, will generally only be proven unsafe after it has caused harm to a consumer or consumers, whereas a prescribed drug is required to be proven safe before it can ever reach the consumer.
In addition, due to the fact that herbal supplements are regulated differently, a manufacturer may be able to make a claim that their product is not permitted for prescription drugs. For example, an herbal supplement may claim that it supports or promotes a specific condition or addresses a certain deficiency.
Herbal supplements, nevertheless, may still lead to legal issues for manufacturers that claim their product provides a cure for a:
- Illness;
- Condition; or
- Disease.
These types of health claims are subject to approval by the FDA.
What are the Nutritional Labeling Requirements on a Dietary Supplement?
There are certain labeling requirements for dietary supplements, which includes ingredients and nutritional content. Dietary supplements, which include DMAA or Arbonne, are required to list:
- All of their ingredients;
- The amount of each individual ingredient; and
- The amount of all the ingredients put together.
If the product contains any types of botanicals that are used as ingredients, the label is required to state what part of the plant they come from. There must be a listing for any significant amounts of dietary ingredients that the FDA has a daily consumption recommendation for.
There must also be a list of the dietary ingredients which are present in significant amounts, but for which daily consumption recommendations are not provided by the FDA. The list of ingredients in the nutrition facts portion should also include the quantity per serving of each ingredient.
What is Prohibited from Being Listed on a Dietary Supplement?
A dietary supplement label is not permitted to list any untruthful or misleading statements regarding the benefits of the supplement. For example, an individual should not be able to find a dietary supplement in a store that claims it cures cancer.
If the manufacturer of the dietary supplement wishes to list any benefits on the label, these statements are required to be approved by the FDA. If a statement pertaining to the supplement’s benefits is provided on the label which is not approved by the FDA, it is required to provide a disclaimer that the FDA has not approved the statement in a reasonable proximity to that claim.
What is DMAA?
The Dietary Supplement and Education Act of 1994 labels as a dietary supplement as any substance, other than tobacco, which contains:
- Amino acid;
- Vitamin;
- Botanical; and
- A combination of those ingredients.
DMAA (1,3-dimethylamylamine) is a dietary supplement which contains a synthetic drug. This synthetic drug contains stimulants which are similar to amphetamines and ephedrine.
What Are Jack3d and OxyElite?
Jack3d and OxyElite are popular, brand name dietary supplements. These supplements are sold as a way to burn fat and increase energy.
Many individuals take these substances as pre-workout boosters. These substances contain DMAA, an ingredient which has caused life-threatening side effects in people who have consumed the product.
What Are the Side Effects of DMAA?
There are numerous possible side effects of DMAA, which include:
- Cardiac arrest;
- Elevated blood pressure;
- Heart attack;
- Heart failure;
- Irregular heart beat;
- Hyperthermia;
- Depression;
- Seizures;
- Headache;
- Insomnia;
- Headache;
- Anxiety;
- Trembling;
- Unexplainable itching; and
- Death.
Why Does DMAA Cause Side Effects?
DMAA is known to cause a narrowing of the blood vessels and arteries, called vasoconstriction. During an individual’s workout, their blood pressure will naturally increase.
DMAA, unfortunately, may increase an individual’s blood pressure level to a life-threatening level.
Can I Sue the Dietary Supplement Maker for Making a Defective Product?
Yes, a dietary supplement maker can be sued for making a defective product. A defective product injury is typically caused due to one or more of the following:
- Defective design;
- Faulty labeling; or
- Defective manufacturing.
If a product is determined to be defective, several parties may be held liable, including:
- The manufacturer;
- The distributor;
- The designer; or
- The retailer.
This means that an individual who is harmed by this type of product may file a lawsuit against one or more of these parties.
What Should I Do If I Have Purchased and Used a Dietary Supplement That I Later Found Had Improper Labeling?
The manufacturer of the dietary supplement is required to meet the requirements provided by the Dietary Supplement Education Alliance (DSEA). If an individual discovers that they have been using a mislabeled supplement, they may want to file a complaint with the manufacturer as well as with the Food and Drug Administration (FDA).
What Do I Need to Prove to Win a DMAA Case?
In order to win a DMAA case, an individual will be required to prove the following before being able to recover compensation for their injuries:
- The manufacturer of the supplement knew or should have known that the supplement containing DMAA was dangerous;
- The manufacturer failed to provide an adequate warning regarding the dangers of DMAA; and
- The plaintiff was harmed by consuming DMAA in a manner which could have been avoided if they had a proper warning regarding the dangers of the substance.
Should I Contact a Lawyer about a DMAA Claim?
Yes, if you believe you have been injured by DMAA, you should consult with a defective products lawyer as soon as possible. Your lawyer will represent you in court and help you recover monetary damages for your injuries.
If one of your loved ones has passed away after taking DMAA, your lawyer can assist you with filing a wrongful death claim.
