There has been an enormous amount of research and papers in recent years, however, that highlight the important role of scientists in validating the often far-reaching claims and the unknown risks of the tDCS industry, and the cognitive enhancement industry in general. In a paper published earlier this year, Dr. Rachel Wurzman and her colleagues draw attention to several controversial problematic issues regarding commercial tDCS products. She indicates that these products’ “indirect effects of stimulation on connected brain networks may alter brain functions that are unintended”.8 Her paper also points to the possibility of “changes [that are] initiated during stimulation can be long lasting and even self-perpetuating”.9 Furthermore, these
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In a paper published in July earlier this year, Dr. Patti Zettler, a professor of law at Georgia State University College of Law, listed strong reasons for the ability of the FDA to enact regulation within the existing regulatory framework. For any tDCS product to come under the jurisdiction of the FDA, it must first meet the requirements of a device under the FDA’s rules. This means that the device, “among other things, is intended for use in the cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body”.10 Zettler argues in her paper that tDCS products can be categorized under the latter, as manufacturers’ “wellness and enhancement claims are generally claims that consumer tDCS products affect the structure or function of the body”.11 The latter category is one in which there is plenty of ambiguity, as it allows for the possibility of products such as exercise equipment to come under the jurisdiction of the FDA. However, historically, to combat this ambiguity, the FDA has exerted its regulatory power on products that “have a therapeutic connotation” when marketed with structure/function claims.12 With strong evidence, scholars are increasingly concerned that it is just a matter of “when”, not “if”, regulation will be brought to this industry. However, a larger problem …show more content…
Another sector of the cognitive enhancement industry has been receiving even more critical attention: brain training. Brain training products are usually in the form of digital mobile or PC games and are claimed to have a wide range of beneficial effects such as improved memory, cognition, thinking, and IQ. However, these overextending claims, in contrast to the tDCS industry, have prompted legal action in recent years. In a case that was settled in January of this year, Lumos Labs, the creators of the leading online brain training platform Lumosity, was charged by the FTC (Federal Trade Commission) with deceptive advertising.13 As part of the settlement, the company had to pay $2 million in redress and notify their customers of the FTC action as well.14 In a press release from the FTC, Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, commented, “Lumosity preyed on consumers’ fears about age-related cognitive decline, suggesting their games could stave off memory loss, dementia, and even Alzheimer’s disease. But Lumosity simply did not have the science to back up its ads.”15 It is not surprising to see a striking parallel here. The brain training industry’s path might foreshadow forthcoming events for tDCS manufacturers. The FTC’s action will urge other counterparts to have reliable scientific evidence before making such far-reaching claims to
In a paper published in July earlier this year, Dr. Patti Zettler, a professor of law at Georgia State University College of Law, listed strong reasons for the ability of the FDA to enact regulation within the existing regulatory framework. For any tDCS product to come under the jurisdiction of the FDA, it must first meet the requirements of a device under the FDA’s rules. This means that the device, “among other things, is intended for use in the cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body”.10 Zettler argues in her paper that tDCS products can be categorized under the latter, as manufacturers’ “wellness and enhancement claims are generally claims that consumer tDCS products affect the structure or function of the body”.11 The latter category is one in which there is plenty of ambiguity, as it allows for the possibility of products such as exercise equipment to come under the jurisdiction of the FDA. However, historically, to combat this ambiguity, the FDA has exerted its regulatory power on products that “have a therapeutic connotation” when marketed with structure/function claims.12 With strong evidence, scholars are increasingly concerned that it is just a matter of “when”, not “if”, regulation will be brought to this industry. However, a larger problem …show more content…
Another sector of the cognitive enhancement industry has been receiving even more critical attention: brain training. Brain training products are usually in the form of digital mobile or PC games and are claimed to have a wide range of beneficial effects such as improved memory, cognition, thinking, and IQ. However, these overextending claims, in contrast to the tDCS industry, have prompted legal action in recent years. In a case that was settled in January of this year, Lumos Labs, the creators of the leading online brain training platform Lumosity, was charged by the FTC (Federal Trade Commission) with deceptive advertising.13 As part of the settlement, the company had to pay $2 million in redress and notify their customers of the FTC action as well.14 In a press release from the FTC, Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, commented, “Lumosity preyed on consumers’ fears about age-related cognitive decline, suggesting their games could stave off memory loss, dementia, and even Alzheimer’s disease. But Lumosity simply did not have the science to back up its ads.”15 It is not surprising to see a striking parallel here. The brain training industry’s path might foreshadow forthcoming events for tDCS manufacturers. The FTC’s action will urge other counterparts to have reliable scientific evidence before making such far-reaching claims to