Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. As is discussed below, careful consideration should be given to the governing regulatory framework so that the statements you make do not trigger a violation. To illustrate this, we are going to look at two examples: products coming under the purview of the Food Drug and Cosmetic Act (“FDCA”) and organic products.
In recent years, consumers have increasingly sought to supplement conventional and approved over the counter and prescription medications with homeopathic treatments and even essential oils. Frequently, the companies selling these products make certain representations regarding the purpose and efficacy of such products. The statements can open a Pandora’s Box for the unwary as such products may, simply by virtue of the statements made about them, become treated as drugs under the FDCA.
A recent warning letter sent by the FDA is illustrative. Abbey St. Clare is a line of skin, hair and makeup products focusing on natural formulas. On September 2, 2016, the United States Food and Drug Administration (“FDA”) sent a warning letter to Abbey St. Clare regarding some of its skin oils and soaps. According to the warning letter, on its website, Abbey St. Clare claimed that one of its botanical oils minimized swelling and was “anti-inflammatory.” Abbey St. Clare provided that another oil was “useful for headaches (including migraines), insomnia, depression, stress, stiff joints, sore muscles, nervous tension, hair loss, and childbirth.” The warning letter advised Abbey St. Clare that its representations on its website about certain products established the products are drugs under Sections 201(g)(1)(B) and/or 201(g)(1)(C) of the FDCA because they are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.” The warning letter went on to advise Abbey St. Clare to review its website, products labels, and other labeling for their products to ensure that the claims they make for their products do not reflect intended uses that cause the distribution of the products to violate the FDCA. The letter requests Abbey St. Clare to take prompt action to correct the violations to avoid a potential enforcement action. The important take away here is the mere act of making these statements caused these products to be viewed by the FDA as drugs and thus subject to the FDCA.
Other essential oil products have been subject to similar treatment. In September 2014, doTerra, an essential oil company, received a warning letter regarding the claims made by its consultants regarding doTerra’s essential oils. The warning letter cited to claims made on a website and in online media, i.e. Twitter, that doTerra’s essential oils could treat the symptoms of Ebola. In response, doTerra began providing an “approved claims” list on their website for consultants. DoTerra’s new requirements limited the representations that sellers could make to those assertions approved by doTerra.
In addition to essential oils, products containing natural ingredients such as seaweed also have received FDA Warnings. On February 25, 2016, the FDA sent a Warning Letter to VitaSea Products Int’l, Inc. dba Watchers Organic Sea Products, stating that certain products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of diseases, and that the claims made are not generally recognized as safe and effective for certain claims. Specifically, the FDA took issue with claims that its Aqua Terra product “May heal wounds, burns and ulcers”, its Sea Green Drink “May help with hay fever, sinusitis and asthma”, and the WTCB-T Cell Balancer “May help speed recovery for patients whose immune system has been compromised by chemotherapy or radiation.” Notably, the FDA warning letter points out that the FDA had an issue with a news flash on the website’s main page that stated: “Seaweed Kills cancer cells and HIV virus.” Although VitaSea’s website didn’t make the claim that any of its particular products kill cancer cells or the HIV virus, it noted that seaweed is an ingredient in some of its products.
Also on February 25, 2016, the FDA issued a warning letter to Herbal Energetics/In Joy Organics stating that products such as its X Out-Rays, Stop it Cold, and SOS Flower Essence were unapproved new drugs because of statement such as “This formula is full of herbs for radioprotection…”, “Stops cold symptoms in their tracks”, “Indications: For trauma…” and the product “Decongest” has an implied claim in the product name. In response, the company removed some of their tincture combinations from its website while it worked with the FDA to come into compliance.
The importance of the wording of advertising is not limited to the drug, supplement, and cosmetics arena. For example, for food manufacturers, advertising their product as “organic” subjects them to a regulatory scheme for using that term. The National Organic Program (NOP) is a regulatory program within the Marketing Services of the U.S. Department of Agriculture (USDA). The NOP regulations require that products sold, labeled, or represented as “organic” must be produced and handled in accordance with certain requirements. The regulation also includes four categories of labeling based on the percentage of organic ingredients in a product.”
Faced with this, what is a manufacturer and seller to do? The above situations highlight two important points. First, when dealing with any sort of product representation carefully consider how a regulatory framework like the Food Drug and Cosmetic Act might apply. You will want to pay close attention to the specific words and phrases used in your advertising. For example, one word, such as “lessening” instead of “removing” as it relates to wrinkles, can change how the product is classified. Another important consideration may be the name of the product. For example, in the supplement arena, the name of the product could impliedly make a treatment claim, like the product “Decongest.”
Second, like doTerra, you must consider how to limit the claims being made by consultants out in the field. Important factors in this regard can include a list of approved statements and strict controls on the use of social media for product promotion.
While this post has focused on discrete areas for illustration, the lessons apply to broader contexts. It is imperative to understand the regulatory framework that governs your product and to understand what types of statements to consumers might trigger enforcement provisions within that framework prior to allowing your company to make those statements.