Both FTC and FDA require that a brand substantiate its products’ claims. Lately, product claims have come under greater scrutiny from regulators, resulting in strong warning letters being issued and formidable fines imposed. High-profile manufacturers have been making the headlinesfor all the wrong reasons.
Recently, there have been consent decrees from FTC, which have led to increased scrutiny of certain claims (claims that are closer to, or actually disease or illness claims rather than structure/function claims), which now require a higher level of evidence: at least two adequate and well-controlled human clinical studies of the product, or of an essentially equivalent product, conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true.
"Essentially equivalent" is defined as: "A product that contains identical ingredients, except for inactive ingredients (e.g., binders, colors, fillers, excipients), in the same form and dosage, and with the same route of administration (e.g., orally) as the covered product; provided that the covered product may contain additional ingredients if reliable scientific evidence generally accepted by experts in the fielddemonstrates that the amount and combination of additional ingredients is unlikely to impede or inhibit the effectiveness of the ingredients in the essentially equivalent product."
It’s a brand’s responsibility to have an evidence file containing “competent and reliable scientific evidence" for each product. For manufacturers of natural health products, going down the path of claims substantiation can be a daunting, confusing and stressful endeavor. The stakes couldn’t be higher.
There are two methods of proving that a product does what it claims:
1. Performing a clinical trial on the marketed product; and/or
2. Compiling a claims substantiation file on the ingredients in the marketed product.
Claims substantiation is a lengthy and demanding process, although it is more affordable and faster than conducting a full-on clinical trial.
A claims substantiation file is beneficial because it enables a brand to confirm the level of evidence supporting a product’s claims, reassure customers with scientific evidence, and support regulatory compliance guidelines.
Substantiating claims entails three steps:
1. Analyze the world’s literature on the ingredients in the product being studied. Grade the literature by level of evidence and extract the most relevant information.
2. Create a summary of substantiated scientific statements. With an eye toward product claims, the existing evidence is summarized into statements, which can be well substantiated by current literature. The evidence supporting each statement is graded and quantified.
3. Take the product claims and match them to the body of scientific evidence. If there is a gap between claims and the scientific statements that can be substantiated by the literature, gap analysis is provided, along with a plan to diminish and bridge that gap so the regulators can be satisfied and the manufacture can best market the product.
The process of substantiating claims means compiling and analyzing all data including tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.
If FTC, FDA or NAD (National Advertising Division) were to ask a brand for the substantiation of its advertising or label claims, it wants to have this information at hand. Just as importantly, customers will also want to have this information.
Don’t wait to be asked for claims evidence before having a claims substantiation file conducted, since waiting can put a cloud of suspicion over products and can delay business. The full substantiation file, including references, should be kept in a secure, but accessible location so that a company, selected customers, partners and potentially regulators, could have access to it if necessary.
Finally, this work should be updated at least yearly (if not quarterly) as new evidence becomes available daily (by some estimates, there are almost 1.8 million new scientific articles published in 28,000 journals each year). Therefore, scheduled searches, reviews and updates must be planned and performed to keep claims set up to date.
Return on investment (ROI) from the claims substantiation process come from:
1. Compliance with current regulatory requirements, which will protect a company in the case of regulatory action;
2. Marketing advantage; a brand can provide its customers with access to the claims substantiation file; and
3. Publication; a whitepaper can be produced and published based on the work performed.
Claims substantiation is a process that is best done before launching a product in the market to ensure that claims are matched with the evidence. In most instances in this industry, products are already marketed, and therefore the substantiation will have to be performed after the product is making claims. In many cases, the evidence in the claims substantiation file may match the existing claims, but in the cases where it does not match, there is still an opportunity to modify the claims or the formula, or to run a clinical trial on the finished product.
For more on the laws that regulate the dietary supplement/functional food industry, visit INSIDER’s Regulatory topic page.
Jay Udani is the founder and CEO of Medicus Research (medicusresearch.com) and Systemedicus (systemedicus.com).