Protein Maxing, Lead Contamination, and the Law: How Supplement Brands Can Stay Ahead of Legal Risks | Husch Blackwell LLP
With the rise of “Protein Maxing” among biohackers, fitness influencers, and health-conscious consumers, a major controversy has emerged that could seriously impact both consumers and protein supplement brands. A recent Consumer Reports article revealed that many popular protein supplement brands contain dangerous ingredients—most notably, lead—at levels that can pose serious health risks with regular consumption. As awareness grows, lawsuits, legal fees, and liabilities for supplement brands are becoming increasingly likely.
Legal Exposure for Supplement Brands: Understanding the Risks
This article outlines key legal strategies for supplement manufacturers and brands to proactively avoid legal troubles and costs related to negative publicity.
As previously discussed in our Future of Functional Foods Report, dietary supplements are subject to less regulatory oversight than traditional foods. For example, dietary supplements do not require pre-market approval from the FDA, whereas many traditional food additives do. Additionally, ingredients marketed in the U.S. before October 15, 1994, which are classified as “old dietary ingredients” (ODIs) under the Dietary Supplement Health and Education Act of 1994 (DSHEA), can be used in supplements without prior FDA notification or approval. By contrast, “new dietary ingredients” (NDIs) require manufacturers to submit a notification to the FDA demonstrating the ingredient’s safety before marketing it.
Whey protein is generally considered an ODI, while certain newer protein supplement ingredients, such as pea protein, are considered NDIs. As such, whey protein does not require a new dietary ingredient (NDI) notification to the FDA before being used in supplement products, but plant-based proteins like pea protein may.
Regardless of notification requirements, dietary supplement brands and manufacturers remain at risk of liability from both regulators and civil plaintiffs if their products fail to comply with the law. Below, we explore several ways legal issues may arise in scenarios similar to the ripple effects caused by the recent Consumer Reports article.
Co-Manufacturing and Co-Packing: Hidden Dangers for Supplement Companies
Surprising as it may be, many supplement brands are unaware of the exact ingredients and contents in their own products. It is a common practice for such brands to use “co-manufacturing” and “co-packing” arrangements, in which production and packaging are outsourced to third-party vendors.
This lack of oversight is a risk for brands, especially since many of the contracts that dictate the allocation of risk and liability in co-manufacturing and co-packing arrangements place full responsibility for regulatory compliance and product liability on the brand, regardless of which entity is more directly involved with the formulation of the products.
Without strong legal advocates to ensure fair negotiation of vendor agreements, a brand can face significant legal exposure and potential expenses. Consumers, competitors, and regulatory authorities alike can bring a multitude of legal claims—from adulteration to mislabeling to formulation issues—against a brand, making it even more imperative that brands know exactly what’s in their formulations and whether the brand or the vendor bears responsibility in the event of legal action.
For example, brands may face lawsuits or regulatory action related to the inclusion of undisclosed allergens, excessive amounts of certain vitamins or minerals, the presence of banned substances, or contamination with harmful compounds such as heavy metals.
Recent concerns about lead contamination in protein powders highlight the seriousness of these risks. When products are found to contain unsafe levels of lead, brands not only face regulatory enforcement and potential FDA Warning Letters, but also an increased likelihood of consumer lawsuits and class actions. This underscores the importance for supplement manufacturers to rigorously test and monitor their products to ensure compliance and protect both consumers and the brand’s reputation.
FTC Enforcement: Deceptive Advertising and Supplement Claims
The Federal Trade Commission (FTC) can take action against brands for deceptive or unsubstantiated advertising claims under the Federal Trade Commission Act of 1914 (the “FTC Act”), which prohibits unfair and deceptive marketing practices that harm consumers via advertising by:
- Identifying the representations made by an advertisement;
- Considering the representations from the perspective of a reasonable consumer; and
- Determining whether the representation is material.
Advertising, in this sense, is a term of art that encapsulates any marketing techniques and promotion methods used to increase consumer interest in or demand for products. The FTC Act requires advertisers to have a reasonable basis for their product claims before disseminating an advertisement.
Beyond just misrepresentations made by brands, even omissions of representations or material facts that are likely to mislead consumers acting reasonably under the circumstances can lead to a violation of the FTC Act. If an advertisement would be misleading without certain key qualifying information, that information must be clearly and conspicuously disclosed.
Furthermore, liability for deceptive and unsubstantiated claims can be imputed to anyone who has the authority to control the marketing of a product (whether directly or indirectly), placing brands (and their representatives) squarely within the crosshairs of the FTC. In recent years, the FTC has taken action against parties ranging from individual owners and corporate officers to product marketers, distributors, ad agencies, and endorsers for violations.
In the event of a violation, the FTC and other regulatory agencies may publicly issue a Warning Letter to brands and advertisers, which almost inevitably attracts attention from consumers and plaintiff’s attorneys, leading to civil lawsuits or even class actions. Defending against these legal actions can be costly and complex for brands. Even if the claims are ultimately unsuccessful, the process can cause significant reputational harm and lasting damage to the brand.
Indeed, even in situations where a Warning Letter does not result in litigation, such letters are public and can still result in harm to a brand’s reputation.
The recent scrutiny over lead contamination in protein powders serves as a clear example of how these legal risks can materialize. If a supplement product is found to contain unsafe levels of lead, brands may face allegations that their advertising was deceptive or omitted critical safety information, triggering FDA or FTC enforcement and Warning Letters. Such regulatory actions often prompt consumer lawsuits and class actions, compounding the financial and reputational consequences for the brand.
This underscores the necessity for supplement manufacturers and marketers to rigorously substantiate all claims and maintain transparency, particularly regarding product safety, to avoid the cascade of legal and regulatory challenges that can follow adverse findings like those related to lead contamination.
FDA Regulations: Nutrient Content Claims and Protein Spiking
The Food and Drug Administration (FDA) regulates nutrient content claims, or claims that characterize the level of a nutrient or dietary substance in a product outside of the Information Panel (for example, “high in,” “low in,” or “a good source of”). These claims must comply with FDA regulations and be properly substantiated.
Protein supplements are a prime example of how nutrient content claims can create regulatory risks for supplement brands. As one of the most popular categories of dietary supplements, protein powders are frequently marketed with claims such as “high protein” or “excellent source of protein.” Because such claims have a legal definition and are therefore subject to FDA scrutiny, any misrepresentation or failure to properly substantiate the protein content can expose brands to regulatory action and consumer litigation.
Further, although current brands do not market their protein supplements as “lead-free,” there is another troubling yet common trend in the protein supplement sphere: “protein spiking,” where nitrogen is added to inflate protein content measurements, misleading consumers about actual protein levels.
As discussed above, the issuance of a Warning Letter by the FDA or FTC can set off a chain reaction of legal and reputational challenges for supplement brands. This risk is particularly acute when it comes to nutrient content claims, which are closely scrutinized by regulators. If a brand makes improper nutrient content claims, it not only increases the likelihood of receiving a Warning Letter, but also heightens the chance of facing subsequent civil lawsuits or class actions initiated by consumers or plaintiffs’ attorneys. Given the high costs and potential for lasting reputational harm outlined earlier, it is crucial for brands to ensure that all marketing and labeling practices strictly comply with applicable regulations.
While FDA and FTC Warning Letters and/or product recalls do not always lead directly to enforcement actions, the violations claimed therein can still be used by advertisers to sue their competitors or force the removal of a competitive product from the market.
NAD Challenges and the Threat of Private Lawsuits
In addition to regulatory action, brands can also face scrutiny from the National Advertising Division (NAD), which reviews the truth and accuracy of national advertising.
Plaintiffs’ attorneys can and do use publicly available enforcement information, including NAD actions, as the foundation for private civil actions against prominent functional food businesses (particularly those with the financial resources to pay large settlements or judgments). Accordingly, even if a business remediates an alleged violation set forth in a Warning Letter and avoids further regulatory enforcement action, the business may be an easy target for plaintiffs seeking civil damages arising from such allegations.
Private civil actions can include false advertising cases, which are generally brought under state consumer protection and unfair trade practice laws, or personal injury claims if an individual is injured by an adulterated or otherwise unsafe product.
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