Unregulated personalised nutrition could cause financial, psychological, and physical harm, according to a study that calls for stronger regulation to reinforce trust and ensure safety and effectiveness.
November 12, 2024
Published in the journal Health Affairs Scholar, the paper outlines the growth of personalised nutrition, an industry that has attracted the likes of Nestlé and Bayer in tailoring dietary solutions to health concerns.
The paper warns that until regulatory bodies address existing regulatory gaps and are provided with adequate resources to exercise those authorities, consumers will continue to encounter products that are “a waste of money and harmful to their health”.
“As a first step, FDA [the US Food and Drug Administration] should acknowledge precision nutrition products as a category deserving concerted attention and create a risk-based framework for assuring that their benefits outweigh their risks,” added the authors.
Lucia Savage, chief privacy and regulatory officer at Omada Health, a virtual healthcare provider based in San Francisco, responded to the paper’s conclusions on LinkedIn.
She wrote: “The article fails to completely mention the hundred-year history of Federal Trade Commission investigation and prosecution of false nutrition claims, as well as the agreement between the FDA and Federal Trade Commission about who does what in the space of consumer- facing health claims.”
The two regulatory agencies play co-operative roles with an arrangement so that they avoid overlap.
The FDA is primarily responsible for overseeing labelling on products, including food, drugs, dietary supplements, medical devices, and cosmetics. Adjacent to this is the evaluation of health claims made on product labels, ensuring they comply with scientific evidence and legal requirements as well as the safety and efficacy of products, particularly drugs and medical devices.
Meanwhile, the FTC deals mainly with overseas advertising and promotional activities for the same categories of products, with a focus on clamping down and enforcing rules on false, misleading, or unsubstantiated claims in advertisements or marketing materials.
The FDA and FTC rubberstamped their collaboration in an agreement in 1971 and have since updated their understanding over the years.
“The FTC’s decisions are all available online… you can look up how many times they’ve fined people for false nutrition claims. It’s actually not rocket scientce and any researcher should be able to figure it out,” said Savage in her post.
The researchers behind the paper, who are based at the Center for Science in the Public Interest, in Washington, were also criticised for their methodology.
To demonstrate the efficacy of personalised nutrition approach (over a population-based one) the team identified six randomised controlled trials (RCTs).
These trials compared the biomarkers or dietary behaviours in personalised nutrition and standard-care groups. None of the studies examined disease outcomes.
While three of the six RCTs showed improvements in at least one biomarker or dietary outcome, the researchers described the magnitude of the improvements as “generally modest”.
“For example, two articles from the same study reported increases in diet quality indices of +0.28 on a 0–14-point scale and +1.27 on a 0–100-point scale,” they said.
“One of the two studies that examined blood glucose outcomes reported small effects (−0.08% for glycated haemoglobin [HbA1c] and −0.97 h/d on time with glucose >140 mg/dL), while the other reported no benefit.
“The results of these studies suggest a potential benefit of personalised nutrition advice on dietary intake, with a less certain impact upon biomarkers and no demonstrated benefit to date on health outcomes.”
Further scrutiny was made by Marion Nestle, Paulette Goddard professor of nutrition, food studies, and public health, Emerita, at New York University.
She wrote in her blog: “Their paper does not deal with the flaws in individualised approaches to nutritional health – ‘precision’ nutrition.
“[This includes] the cost, the difficulty, the lack of support, and the inability to reach those who most need support. Instead, it focuses on the commercialisation of personalised nutrition.
“Regulatory gaps have led to market growth of products with unknown efficacy that are making bold, and possibly unsubstantiated, claims.”
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