Adverse Event Reporting Could Limit Access to Supplements

The Dietary Supplements and Non-Prescription Drug Consumer Protection Act (called the Adverse Event Reporting Act) could limit the availability of vitamins and supplements. The Act amended the Federal Food, Drug and Cosmetic Act and gutted the Dietary Supplements Health and Education Act of 1994. The new law changes the classification of vitamins and supplements from food to over-the-counter drug and makes it mandatory for companies to report any adverse events related to their use.

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Adverse events were already being reported by healthcare practitioners and consumers who believe that an adverse reaction was caused by a dietary supplement, through an FDA program called MedWatch Turmeric private label. Furthermore, people who take vitamins and supplements should be discussing their adverse reactions (especially serious ones) with their doctor, rather than calling in a complaint to the manufacturer or retailer.

There is a potential for error, and vitamins could be blamed erroneously instead of pharmaceutical drugs, recreational drugs, or food intolerance. Supplement companies cannot collect health information on the person reporting the event, including medications or health history, so there is no way to tell if the adverse incident was the result of multiple-drug interaction, drug-nutrient interaction, or food intolerance.

Even when we consider the adverse events related to ephedra, dietary supplements have a better safety record than drugs and pose relatively small health risks. Did you know that over 100,000 Americans are killed each year by doctor-prescribed medications, and at least 3 million are hospitalized? Conventional foods pose a greater health risk than supplements. According to the Center for Disease Control, conventional foods cause about 5,000 deaths and 80 million hospitalizations a year in the U.S.

This law was prompted by critics of the supplements industry who would like to see supplements held to the same pre-market testing and approval as pharmaceutical drugs, despite the fact that they are not drugs. The Dietary Supplements and Non-Prescription Drug Consumer Protection Act does not address the argument that unlike drugs, supplements are not subject to the same tests, so it is conceivable that more amendments will be coming in the near future. Moreover, it should be noted that the Food and Drug Administration does a dismal job of policing the pharmaceutical industry, whose products pose a higher risk of fatality and long-term adverse effects than supplements.

This law will have a very detrimental effect on small supplement manufacturers, retailer and distributors. Supplement makers will
incur added expense to comply with the law and these costs will be passed on to retailers, independent distributors and consumers. Mandatory reporting and retention of records will add to companies’ record keeping, while providing no measurable increase in safety to the consumer. Adding a telephone number to product labels so consumers can call to report adverse events will be an additional expense.

Staff will have to be trained to assess the severity of an event and to determine whether it is a “serious event” as defined by the bill or if it is the type of event that, according to the law, must be recorded and maintained for six years. Manufacturers will also incur additional expense to determine whether or not the adverse event was caused by their product. Proving a negative is sometimes a costly and time-consuming process.

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