As longtime fans of shows such as “Dateline," “CSI: Crime Scene Investigation," and even “Maury" with its endless paternity tests, the consuming public has come to associate any reference to DNA with irrefutable proof. Thus, when New York Attorney General Eric Schneiderman claimed in February 2015 that “DNA barcode testing" revealed the dietary supplements sold by some of the nation’s largest retailers were not what they claimed to be, it served as a sucker punchnot just to the retailers in question, but to the nutraceuticals industry as a whole. Since the initial announcement, Schneiderman’s testing methods have been questioned and any lasting effect on consumers or the market remains to be seen. What is clear is that there has been a push initiated within the industry to better inform consumers about content and quality.
How then, as a manufacturer or marketer of dietary supplements and functional foods, can brands convey to consumers that its products have been tested without running afoul of the law? The answer to this question is simple: brands must tell consumers the truth. Some manufacturers and marketers intentionally misrepresent that their product has passed tests when it has notthis is obviously wrong. Fortunately, the vast majority of the industry has every intent to be honest in their disclosures to consumers. Unfortunately, good intent is not enoughas the retailers addressed earlier learned the hard way, brands and retailers can still be held accountable for statements they believed to be true, which are later proven false.
The nature of the industry lends itself to such confusion. Most supplements are composed of several ingredients, each of which passes through numerous hands before it makes its way first, into a product and second, into the bodies of consumers. Every step in the processing chain presents an opportunity for dilution or contamination, whether accidental (as in the case of products being processed at a facility that handles a common allergen, such as peanuts) or intentional (as in the case of cost-cutting measures). Restated from a legal perspective, every step in the processing chain presents potential liability for manufacturers or marketers associated with the product.
Identity testing, it seems, is the best solution for this conundrum, but it presents its own risks. If you must tell consumers the truth, then you must not misrepresent the nature or extent of testing methods. The following is a basic list of “dos" and “don’ts" to help minimize these risks:
• Don’t rely on suppliers for testing. The only way to ensure products have been properly tested for ingredient identity, contaminants and/or stability is to have the testing performed by a reputable facility that is not affiliated with the supplier. A good supplier will cooperate with independent testing effortsafter all, if there is a problem with the supplier’s own sources or testing methods, the supplier will want to know about it. However, if a brand is a new or low-volume account for the supplier (i.e., someone without a lot of bargaining power), it may seem as though the supplier’s standard agreement is written to prevent outside testing. For example, the supplier may require rejection of contaminated product within a narrow window that does not accommodate the time required by most testing facilities. While such terms should serve as a red flag that the supplier’s agreement as a whole is unfair and one-sided, the inability to reject or return product does not excuse a brand from testing it prior to offering selling it.
• Do thoroughly know each ingredient. If there is an argument to be made in favor of stronger regulation of the supplement industry, it is that the current framework has permitted merchants to approach their products from a purely business or marketing perspective as opposed to a biological or chemical one. Brands need to know and understand their products, and each element thereof, before it offers it to others. Facilities need to maintain a file with all of the latest information about a product’s ingredientsespecially all peer-reviewed studies pertaining to the benefits a brand uses in its claims. This research will not only provide a brand with the requisite support for its product claims, but it will help navigate test results.
• Don’t base current disclosures on past test results. The legal protections afforded by testing are only good for products that are actually tested. As such, interest in testing should not rise and fall with the first batch.
• Do institute recordkeeping procedures. Draft written policies and procedures that outline where certain key recordse.g., test results, scientific support and supplier agreementsare to be kept, and adhered to. A routine backup schedule should also be included.
• Don’t mimic the competition. In the rush to market, too many merchants will look to their competition’s advertising, labeling and cited scientific studies as support for their own product benefit claims, with the assumption that the competitor has had its supplement tested and advertising vetted. This faulty “everyone else is doing it" approach is one of the key factors that has led to heightened scrutiny of the industry. As testing certification becomes a bigger issue for consumers, resist the urge to copy the competition’s flashy “DNA Barcoded" badge.
• Do protect the brand with an indemnification agreement and insurance policy. A supplier agreement should contain a provision wherein the supplier agrees to indemnify a brand for any claims that the product is diluted or impure. Similarly, a brand should maintain an insurance policy sufficient to cover such claims. The point of each is that if, despite best efforts the product is still questioned, a brand has the financial ability to defend against and/or settle the claims.
While the foregoing list is not all-encompassing, it provides a basic framework to arm yourself with the information and evidence necessary to defend against legal action related to your testing methods or claims. More importantly, it prevents a brand from making promises to consumers that it cannot keep.
Ginny Sanderson ([email protected]) is a partner in the Internet-focused law firm, Kronenberger Rosenfeld. Sanderson advises the nutraceuticals industry on FTC and FDA compliance, advertising and product claims, billing practices, intellectual property (IP) and more to ensure compliance with state and federal laws and regulations.