Wednesday, May 22, 2024

Advertising of Drugs and Supplements


Avid football fans and advertisers look forward to the Super Bowl football game, held every year in February. This weekend, the American Football Conference’s Kansas City Chiefs square off against the National Football Conference’s Philadelphia Eagles at State Farm Stadium in Glendale, Arizona on February 12, 2023.

With over 99 million U.S. viewers last year, the Super Bowl is one of the most expensive venues for advertising. This televised event attracts new commercials featuring cars, trucks, insurance, and beer, as well as advertisements for prescription and non-prescription medicines.

With sales of dietary supplements topping $12 million dollars in 2021, food supplements are big business. Who knows? We may even see an herbal supplement advertised during the Super Bowl.

Compared with non-prescription and prescription drugs, food supplement advertising and labeling has different rules. Allowing advertising medications to consumers is called DTC (direct to consumer) advertising.

The Food and Drug Administration (FDA) controls the advertising rules for prescription medicines. The Federal Trade Commission (FTC) is responsible for the advertising of non-prescription (over the counter or OTC) drugs and dietary supplements. These two federal agencies have separate responsibilities for OTC medications and herbal supplements: the FDA oversees their labeling while the FTC makes the rules governing how they are marketed to the consumer.

The FDA is tasked with making sure promotion of prescription drugs is truthful, balanced, and accurately communicated to doctors, pharmacists, and consumers. In contrast, the advertising of OTC medicines and dietary supplements regulated by the FTC has far fewer restrictions.

Direct to consumer (DTC) advertising of medications is controversial. Its supporters believe it encourages people to talk to their physician about health concerns. DTC advertising can also help remove the stigma of a disease or condition such as depression or erectile dysfunction.

Opponents of DTC advertising fear it encourages use of drugs for conditions with non-drug options or less expensive treatments available.

Dietary supplements contain a “dietary ingredient” intended to supplement your diet. It can include vitamins, minerals, enzymes, herbs and botanical compounds, even live microbes, or probiotics. If a dietary supplement represents itself as treating, curing, or preventing a disease, it is considered a drug.

Before they can sell a single dose, manufacturers of prescription and non-prescription medications must spend money up front to collect proof that their product is reasonably effective and safe, then submit the evidence to the FDA for approval.

Herbal and dietary supplements are treated as foods under FDA rules. Although they don’t have to provide any proof to the FDA that their product is safe and effective, they are responsible for ensuring their product contains what its label says it does.

Although the FDA is limited to post marketing enforcement, it can prosecute manufacturers of foods and dietary supplements if they find evidence of either misbranding or adulteration. Misbranding is selling a product that contains ingredients other than the ones on the label. Adulteration is selling foods or dietary supplements with one of the main ingredients spoiled or removed. These transgressions are called food fraud.

Some examples of food fraud include adding corn syrup to honey or maple syrup, then labeling it and selling it as 100% pure, and diluting olive oil with inferior oils and selling it labeled as pure olive oil. The FDA has uncovered spices with miscellaneous non-spice plant material added, and spices colored with dyes containing lead in an attempt to make the spice appear fresher.

In addition to being required to label their products accurately, if a manufacturer claims particular benefits from a dietary supplement, they must also include two specific statements as a disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

Direct to consumer (DTC) advertising of medications is controversial. Those who support marketing medicines directly to consumers state that it’s helpful because it encourages people to talk to their physician about a health concern they may have. DTC advertising can also help remove the stigma of a particular disease or condition, such as depression or erectile dysfunction.

Opponents of DTC advertising believe it promotes increased use or overuse of drugs for conditions that have non-drug treatments or less expensive treatments available. They also fear that not enough attention is paid to risks of new medicines, like serious side effects. Marketers want their product presented in the best possible light, and false or misleading claims can slip in. Who knows? Maybe we’ll see an advertisement for a dietary supplement during this year’s Super Bowl.

Dr. Louise Achey, Doctor of Pharmacy, is a 43-year veteran of pharmacology and author of Why Dogs Can’t Eat Chocolate: How Medicines Work and How YOU Can Take Them Safely. Get clear answers to your medication questions at her website and blog Ó2023 Louise Achey


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