The two main agencies that handle enforcement for dietary supplements and cosmetics are the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). The FDA regulates the validity of claims made on labeling as well as the safety and manufacturing of supplements and cosmetics. The FTC regulates product advertising. The two agencies can and often do take joint action against a manufacturer, though they also act independently. When the FDA is determining whether a label claim is valid, they review a lot more than just the product’s label. The FDA also reviews websites, Facebook posts, and other printed materials to determine the intended use of the product and therefore whether improper claims were made. Similarly, the FTC can review information on a product’s label to make determinations about whether to bring an enforcement action. The two agencies often review a lot of the same materials to bring joint, but separate enforcement actions.
Dietary supplements and cosmetics enjoy the freedom to enter the market without having to be pre-approved by any federal agency, as drugs would. The burden of the product’s safety and ingredient verification falls on the manufacturer. However, once the products have been introduced into the market, the FDA and FTC gain jurisdiction. This structure is controversial. Many people think that the FDA and FTC are overly constrained in their ability to regulate the field of dietary supplements and cosmetics. Some argue that dietary supplements, especially, should have a more comprehensive and complicated pre-market approval required by the FDA, similar to what is required for pharmaceuticals.
The enforcement structure we have in the U.S. grants leeway for dietary supplements and cosmetics to enter the marketplace with few barriers. The enforcement agencies, then, are playing catch-up, and trying to track down products they consider dangerous or ones that have been mislabeled. The enforcement agencies have several tools at their disposal to react to manufacturers whose products they consider to be misbranded, misleading, or outright dangerous. Typically, a manufacturer is first alerted to a problem via a warning letter from either agency. Enforcement strategies can escalate from there to inspections, seizures of products, civil penalties and fines for consumer refunds.
The most common enforcement action from either agency stems from claims that a product that has not been approved as a drug can cure, treat, mitigate or prevent a disease. However, the FTC does not follow the distinctions between categories of health-related products or claims as the FDA does. Whereas the FDA spends a lot of time and energy classifying products via the intent stated on the label, i.e., defining a drug versus a dietary supplement versus a cosmetic, the FTC isn’t concerned with those categories. Similarly, the FTC does not regulate the differences between structure/function claims as opposed to health or qualified health claims. The FTC is only concerned with truthfulness and whether claims can be substantiated with sufficient scientific evidence.
i. Food and Drug Administration Enforcement
Since the FDA has no authority over dietary supplements and cosmetics before they enter the market, the backbone of their enforcement strategy is the adverse reporting system. This is a mandatory reporting requirement for manufacturers, who only have 15 days to report any serious adverse health event to the FDA via the Med Watch website or Safety Reporting Portal. This is why you must put the business name and address on each label! The FDA wants to encourage people who have reactions to these products to report them to the manufacturer, who then is required by law to make the FDA aware of side effects.
Serious adverse events are those that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect or requires a medical or surgical intervention to prevent any of those outcomes.
Reports of this nature are how the FDA tracks dangerous supplements and cosmetics. One study concluded that dietary supplement adverse events cause over 20,000 emergency departments visits in the US annually. The events commonly involve cardiovascular manifestations from weight loss or energy products in younger adults, micronutrient ingestions by unsupervised children, and swallowing problems, usually from micronutrients, in older adults. Botanicals are rarely implicated in adverse event reporting.
However, the FDA has other tactics to regulate the botanical supplement industry. They review labels to look for impermissible health-related claims or ingredients that are known to them to present a significant or unreasonable risk of illness or injury when used as directed. Botanical products are more likely to be engaged due to an impermissible claim or unsafe ingredients than because of serious adverse event reporting.
The first interaction your business might have with the FDA is a Warning Letter. These letters are the FDA’s attempt to get businesses to voluntarily comply with the law. As stated above, many of these are sent after the FDA views impermissible claims on labeling or on a business’ website, but they can also be sent due to poor manufacturing practices.
The letters outline, in general form, what the issue is, and what the company must do to correct the problem (“corrective actions”). Companies only have 15 days to respond after receiving a Warning Letter from the FDA. If the FDA can verify via an inspection that acceptable corrective actions have been taken, then they will issue a close-out letter, effectively settling the matter. However, the company is susceptible to future inspections to assess that the corrections are sustained over time.
The FDA does not give companies examples of acceptable claims if their complaint is that the claims made are reserved for products that have been approved as drugs. Therefore, even if the FDA gives corrective actions, often, companies will need assistance from an attorney, or at the very least, fellow botanical producers to attempt to correct the issue.
If the Warning Letter is not heeded, or the FDA does not accept the corrective actions taken, then enforcement can escalate to:
- Public warnings and alerts,
- Further inspections and corrective actions,
- Recalls (voluntary or mandatory),
- Products being administratively detained for a period of 30 days,
- Seizures of product, or
- Criminal enforcement.
Examples of FDA Enforcement Actions: Complexities & Consequences
Kratom is an example of the scattershot approach the FDA must take to regulate dietary supplements. Kratom is a tropical tree that grows naturally in Southeast Asia that has been linked to toxicity in multiple organ systems. A quick google search will return several instances of death from kratom ingestion. Often, kratom is taken in response to pain, coughing, depression, and opioid withdrawal. In 2014, the FDA issued an alert that allowed US officials to detain imported kratom without physical examination. In 2016, the FDA administratively detained a brand called RelaKzpro. After the 30-day administrative detention expired, the FDA obtained a court authorized seizure action. The Department of Justice then filed a complaint against the company that the dietary supplements containing kratom were adulterated. Other companies that distributed kratom have faced civil suits worth over 10 million dollars in damages. The FDA has warned consumers not to use kratom products. However, even in 2021, 78 serious adverse reports were received about kratom products.
Blossom Nature, LLC was one of ten companies the FDA targeted in a push to find and regulate dietary supplements that claimed to treat depression. Some of the specific impermissible drug claims Blossom Nature made were that their St. John’s Wort product was a “natural treatment for mental health problems,” or was “effective as prescribed antidepressants but with no side effects.” Blossom Nature’s St. John’s Wort is still for sale via their store on Amazon, but the label now reads, “for positive mood,” and “supports overall wellbeing,” both with the appropriate disclaimer. But, Blossom Nature’s problems didn’t stop there, even though the FDA issued a close-out letter. A state class action lawsuit was filed claiming deceptive and unfair advertising, marketing and sale of a worthless, misbranded drug. The case is being heard in California.
ii. Federal Trade Commission
The FTC’s job is to protect consumers from fraudulent, deceptive, and unfair business practices. They review advertisements on the internet, in broadcasts, or in print to ensure that they are truthful and do not mislead consumers. Furthermore, advertisers are required to have adequate reliable scientific substantiation for all objective product claims they make so that the FTC can verify the claims if the FTC doubts their accuracy. The FTC can obtain a court order that stops the deceptive claims and requires that the company’s future marketing be truthful and substantiated. They can also require certain disclosures in future advertising. At the most extreme, the FTC can ban a company from engaging in certain marketing practices and/or seek financial remedies.
If the FTC does file a complaint against a company, the FTC and the company can enter into a stipulated final order that acts as a settlement. Settlements typically come with monetary fines, but the defendant-manufacturers do not have to admit guilt to the unfair or deceptive practices accusations. Any complaint that the FTC files is logged into an online database, which is then available to approximately 1,800 civil and criminal law enforcement agencies.
FTC Enforcement Against Acai Berry Weight-Loss Products
In 2012, the FTC went after six online marketers that were creating advertisements that looked like news sites. This is a good example of how the FTC uses its enforcement powers.
The websites in question were designed to appear as if they were part of legitimate news organizations, going so far as to title their ads “News 6 News Alerts,” “Health News Health Alerts,” or “Health 5 Beat Health News.” The sites also insinuated that major news outlets had also published these ‘stories’ that purportedly documented a reporter’s first-hand experience with acai berry supplements. The claim was that the writer had lost 25 pounds in four weeks. These are some bold advertisements,
especially since the FTC is particularly focused on weight loss claims.
After being made aware of these advertisements, the FTC had federal courts temporarily halt the operations of the involved manufacturers. Eventually, all six online marketers agreed to settlements with the FTC that permanently halts their use of fake news sites to advertise acai berry supplements. In the future, businesses must make clear that their advertisements are ads and not journalism. More importantly, the settlement required the defendants to collectively pay roughly half a million dollars to the Commission. This money amounted to most of their assets.
Action Steps for the Botanical Producers
The FDA regulates labeling and health-related claims and the safety and manufacturing of supplements, cosmetics, and food. The FTC regulates product advertising. Often, the two agencies work together. Each has an escalating list of enforcement strategies, including warning letters, inspections, civil or criminal actions, seizures, and fines.
The Action Step for this chapter is to familiarize yourself with the enforcement strategies of the FDA & FTC. Develop a readiness plan to tackle any communication or inspection by the FDA.