Dietary Supplements and Herbal Remedies in Miami, Florida

Pharmaceutical Liability Information Center

Dan Dolan has secured substantial settlements and verdicts from physicians, pharmacists, hospitals, and pharmaceutical companies for prescription drug errors. He is a former insurance defense lawyer whose insights enable him to maximize compensation of behalf of permanently injured clients. Call (305) 371-2692 to discuss your potential claim. We can come to you.

Dietary Supplements and Herbal Remedies

Dolan Law Firm aggressively pursues compensation for catastrophic injury or death resulting from doctor errors, pharmacy errors, or hospital errors in providing drugs to patients: wrong dosage, wrong medication, deprival of the right medication, or failure to account for contraindications.

The production and sale of dietary supplements and herbal remedies is a huge and largely unregulated business in the United States. While dietary supplements and herbal remedies may be safe in most circumstances, they are not risk-free and can cause serious side effects, just as drugs do. The federal Dietary Supplement Health and Education Act of 1994 (DSHEA) governs the regulation of dietary supplements. DSHEA also sets forth rules for making claims about products and information that must appear on labels. A lawyer at Dolan Law Firm in Miami who is familiar with the statute’s requirements can help you determine whether you have a claim against a manufacturer and whether you can recover damages for your injuries.

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Before Congress enacted DSHEA, dietary supplements were regulated by the Food and Drug Administration (FDA) as food. However, under DSHEA, ingredients in dietary supplements are no longer subject to the pre-market safety evaluations to which other new food ingredients are subject. Under DSHEA, manufacturers are responsible for making sure that their dietary supplements are safe before they are marketed. DSHEA defines dietary supplement as a product (other than tobacco) that is intended to supplement the diet that:

Bears or contains one or more of the following ingredients: a vitamin, mineral, herb or other botanical, amino acid, dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract or combination of these ingredients
Is intended for ingestion in pill, capsule, tablet or liquid form
Is not represented for use as a conventional food
Is labeled as a "dietary supplement"
Includes products such as an approved new drug, certified antibiotic or licensed biologic that was marketed as a dietary supplement or food before approval, certification or license

Dietary supplement labels must have the ingredients listed on them. The information must include the name and quantity of each dietary ingredient, or for proprietary blends, the total quantity of all dietary ingredients in the blend. The label must also state that the product is a "dietary supplement." The label must also contain nutritional information and list dietary ingredients in "significant amounts" for which the FDA has established daily consumption recommendations and a list of ingredients with no daily intake recommendations.

Permissible Claims Manufacturers May Make

DSHEA provides that various statements can be used on dietary supplement labels. Dietary supplements cannot contain claims about the use of the supplement to diagnose, prevent, mitigate, treat or cure a specific disease. Under DSHEA, only drugs can "treat, prevent or cure" a medical condition. Instead, manufacturers of dietary supplements and herbal remedies can make health claims, nutrient-content claims and structure/function claims. These terms are defined in DSHEA. The statute provides that if the manufacturer makes one of these permissible claims, it also must provide a disclaimer on the product label that advises the consumer that the FDA has not evaluated the truth of the claims.

Combining Supplements and Herbal Remedies with Other Medications Can Be Dangerous

When some dietary supplements or herbal remedies are taken at the same time as certain prescription or over-the-counter medications, the combination can be dangerous, even life threatening. For example, if you have a heart condition and are taking Coumadin® (a prescription blood-thinner), you should not take aspirin, ginkgo biloba or a Vitamin E supplement because those substances are also blood thinners. If you are taking a prescription medication to treat depression, it is generally recommended that you not take St. John's Wort.

Another situation where you should be especially cautious and discuss your plan to use the supplement with your doctor or pharmacist is if you have a chronic medical condition, such as heart disease, hypertension or diabetes. It also is wise to discuss the supplement if you intend it for one of your children, or if you are pregnant or nursing a baby, since the products are generally formulated for adults.

Note also that some supplements and herbs can affect your vital signs, such as your heart rate, blood pressure and the ability of your blood to form clots. If you are scheduled for elective surgery, talk to your doctor. He or she may recommend that you stop taking the supplements and herbs several weeks before the surgery. Also, let the surgeon and anesthesiologist know what you have been taking.

Conclusion

Do not assume that herbal remedies or supplements do not have the potential to cause serious health consequences. If you have been harmed because of your use of one of these products, you have rights. Contact a lawyer at Dolan Law Firm in Miami who has experience with dietary and herbal supplement cases to discuss your situation.

DISCLAIMER: This site and any information contained herein are intended for informational purposes only and should not be construed as legal advice. Seek competent legal counsel for advice on any legal matter.

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