FDA Looks Forward to Consumer Complaints to Rein In Supplements
​[Posted on: Thursday, July 27, 2017]

FDA and FTC want consumers to help them find sellers of dietary supplements who make dubious claims or sub-standard products. Seems simple enough, but it is not. The agencies need stronger laws and additional resources to enforce the laws regarding supplements. Consumer complaints are not the answer. Dietary supplements account for about $100 billion sales per year in the US with more than 40,000 products. Practically every consumer in the US takes at least one supplement daily. The diversity of supplements is mind boggling; they range anywhere from simple vitamins to complex botanicals. And supplements are frequently found to misrepresent by using pseudo-medical terms to describe the product such as nutraceuticals, and making claims that tread the fine line between managing better health and curing diseases. Technically supplements are required to meet strict GMP requirements for manufacture, and follow truthful and non-misleading labeling and marketing practices. But supplements do not require registration with the FDA or FTC, and do not require approval of their advertisement by any government agency, making it hard for the FDA to regulate this industry. The laws are sparingly enforced due to resource limitations at both FDA and FTC. The lion’s share of FDA’s auditing resources is dedicated to prescription products, while FTC monitors all products, not just food and supplements. So, most supplements slip through the cracks unless there is a major adverse event. Hence regulators seek consumers’ help to identify defaulters but that’s where the problem lies. Consumer complaints are subjective. For an average consumer, the presence of a supplement on store shelves creates the false impression that it meets regulations. On top of it widespread advertisement of broad medical claims creates an impression that FDA/FTC is aware and allowed such ads. When there is an adverse event, it is hard for the consumer to know if it was caused by the supplement or if there is another reason. This leads to two outcomes. Either the consumer will ignore the side effect and not complain. By some estimates 9 out of 10 consumers take this option and the adverse event is never reported. The other option is for the consumer to complain to the store from where they bought the product, their doctor, the manufacturer, or the FDA/FTC, in that order of preference. Complaining to the FDA is usually the last resort for an average consumer, and it is a tedious process to fill the forms and submit the complaint. That said, just the sheer number of people taking supplements assures that the number of complaints received at FDA will likely cause an information overload at these Agencies, which in turn will lead to frustration for the consumers who complained but never heard a response, and then never complained again. Unfortunately, this circular logic assures that FDA’s request to consumers will not change the landscape. We need Agencies with teeth that bite, and not hands tied behind their backs to enforce a critical element of a consumer’s daily healthy life.