Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.
Communicating with FDA
Joe’s Innovation Health Products, LLC came up with an innovative consumer healthcare product.
Joe, the CEO, told me that the product would apply chamomile, a dietary supplement, through a skin patch into the body to produce profound calm and relaxation, help athletes heal faster, and alleviate insomnia.
Unfortunately, Joe had made the mistake of communicating his idea to FDA by email to get a preliminary read. Joe had done so without legal counsel.
Initially, Joe received several nice emails which directed him to various resources on the FDA website, but later, an email which Joe interpreted as “stonewalling.” Joe was furious and asked me why FDA had blocked his path to market and what he could do.
Also, the FDA correspondence left Joe confused: did he have a dietary supplement, a cosmetic, a medical device, or a drug? What would be the best regulatory strategy to get to market?
(Note: as with all the case studies on this blog, the facts have been changed quite a bit to disguise the actual problems. These are illustrative only, and not legal advice.)
Watch our for Disease Claim
One mistake Joe had made, in touting the beauty and benefits of his healthcare product, was to make disease claims.
In general, claims about calm and relaxation are usually innocuous enough; claims about rapid healing trigger concern that these might reference things that drugs do; and, claims about alleviating insomnia, a disease, fall into the disease category.
FDA has 10 different criteria under which a claim can be considered a disease claim.
- Claims an effect on a disease or class of diseases
- Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology
- Claims an effect on a condition associated with a natural state or process
- It is an implied disease claim because of the product name, formulation, use of pictures, or other factors
- Claims that a product belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease
- Claims to be a substitute for a product that is a therapy for a disease
- Claims to augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease
- Has a role in the body’s response to a disease or to a vector of disease
- Claims to treat, prevent, or mitigate adverse events associated with a therapy for a disease
- Otherwise suggests an effect on a disease or diseases
Look out for the word “otherwise.” It’s a catch-all.
In this case, the FDA official responding to Joe went through all of Joe’s marketing materials, including his website, and then pointed out several disease claims, in addition the one about insomnia.
Joe had basically shot himself in the regulatory foot.
FDA Regulates Combination Products
It’s important to work with legal counsel to understand whether your product could be regulated by FDA as a:
- Rx Drug
- OTC Drug
- Dietary Supplement
- Medical Device
- Biologic
FDA can also find that you have a combination product.
For example, Joe made the mistake of thinking that because his main ingredient is chamomile, he has a dietary supplement. However, Joe’s product is not meant to be consumed by mouth (i.e., as a supplement to a meal). Rather, the mechanism of action is transdermal and the intent is to alleviate or cure diseases. As such, it could be a combination medical device/therapeutic drug. In this case, Joe is looking at a much steeper (costlier and more burdensome) regulatory path to market than what he had intended.
Benefit of Working with FDA & FTC Legal Counsel
A good FDA lawyer doesn’t just tell you the bad news; he or she proactively works with you on regulatory strategy, explaining how this affects your marketing strategy – or even your formulation of the product.
For example, our law firm has worked with pain patches – which are regulated as medical devices; but, some are regulated as exempt from FDA 510(k) clearance (i.e., easier path to market), while others can include drug delivery systems (i.e., combination medical device/drug). The claims suggest intended use, as does the mechanism of action. It’s important to clarify at the outset what the product is intended to do, and how it’s supposed to do it.
Here, Joe felt he got stonewalled by the FDA because FDA had very clearly read his product as a combination product requiring a steep path to market, including clinical data. So when Joe requested a meeting with FDA officials, FDA denied the meeting; referred Joe to a bunch of guidance documents that Joe found very arcane; and wrote in a way that Joe interpreted as dismissing his market ambitions.
They say a camel is a horse designed by a committee; but when we reviewed the FDA correspondence, FDA’s logic became clear – within the universe of FDA rules.
One of the things FDA said was that Joe would need to get an IND simply to collect clinical data. “Anecdotal” data about the benefits of the product were insufficient.
Joe would have done better to consult legal counsel before writing to FDA. An FDA lawyer could not only advise Joe on how FDA would likely view his product and the strategy to market, but also could manage communications with FDA so as to avoid sending FDA any literature that would in fact intensity Joe’s regulatory burden, and be counterproductive.
A Word about Foreign Countries Targeting Sales to U.S. Customers
Foreign companies must consider that FDA will assert jurisdiction whenever a company manufactures or distributes an FDA-regulated product in U.S. interstate commerce. This includes a situation in which a foreign company makes sales or actively markets to U.S. customers, even if the website is hosted in a foreign country, has a foreign domain, or has its principal home page in a foreign language.
More about Product Classification
Here is a fuller list of FDA classification. In general, FDA may classify a given health product as one of the following:
- a food or dietary supplement
- a drug
- a medical device
- a radiation-emitting product
- a vaccine, blood or biologic
- an animal & veterinary product
- a cosmetic
- a tobacco product.
While these various kind of products have different statutory definitions, FDA gives some examples to clarify common use. For example, drugs include prescription and non-prescription drugs; medical devices include tongue depressors and dental devices; biologics include vaccines and blood products.
Classification depends in part on intended use—i.e., the way in which FDA can reasonably conclude, based on the product labeling, that the manufacturer intends the product to be used. “Labeling” means not only the label on the box, but also any written, printed or graphic material accompanying the product (including the website).
As we’ve said: If the product labeling makes disease (or therapeutic) claims—essentially, those that claim a product will diagnose, cure, mitigate, treat, or prevent disease—then FDA will likely regulate the product either as a drug (which must be FDA approved, and requires prior proof of safety and efficacy before selling the product in interstate commerce) or biologic (which also requires FDA approval), or as a medical device (which, unless exempt from 510(k) requirements, must be cleared for interstate distribution by FDA).
A words about drugs vs. biologics vs. medical devices: FDA looks to the mechanism of action in terms of how the product achieves its intended primary purpose. For example, if the product achieves its primary intended purpose through chemical action within or on the body and is metabolized by the body, it will likely either be deemed a human drug or biological product. On the other hand, if the product is an “instrument, apparatus … machine…” which, among other things, is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, then it is likely a medical device.
In terms of FDA internal jurisdiction, human drug products are regulated by Center for Drug Evaluation and Research (CDER). Biological products are regulated by CBER. Medical devices are regulated by CDRH. The Office of Combination Products regulates combination products (those therapeutic and diagnostic products that combine drugs, devices, and/or biological products).
Dietary supplements are consumed by mouth. In ordinary language, FDA states that a dietary supplement “is a product intended for ingestion”—one that contains ‘‘a ‘dietary ingredient’ intended to add further nutritional value to (supplement) the diet.” Dietary supplements ordinarily do not need to be proven safe and effective before brought to market, provided that no disease claims are made, and the dietary supplements do not contain a new dietary ingredient (NDI) which requires FDA approval. This why if you can, market a dietary supplement, not a drug or device.
Coda: Substantiate Your Claims
As we noted, FDA told Joe that he could not market his products based on anecdotal evidence. FDA takes this very seriously for not only drugs and medical devices, but also dietary supplements.
Both FDA and the Federal Trade Commission (FTC) require that all statements regarding a product need to be truthful and non-misleading. Among other things, this means that the advertiser must have adequate substantiation or underlying evidence for the intended use. Normally, this means the claim must be supported by “competent and reliable scientific evidence.”
Similar legal rules regarding advertising may also be enforced under comparable state laws by state attorneys general and other regulatory bodies.
FTC penalties can be significant and can include disgorgement of all profits made over several years from sales of the products. FTC is really the gorilla here, with multi-million penalties that can tank a company.
Unsubstantiated or inadequately substantiated claims are not only problematic from the FDA perspective; they can also generate lawsuits from private plaintiffs.
Law firms representing plaintiffs are actively looking for new entrants to the dietary supplement market and scrutinizing their websites and marketing materials for potential fodder for large, class-action lawsuits. These law firms appear to enjoy devouring companies that are unprepared for the legal complexities and nuances of this highly regulated market segment.
When to get an FDA Regulatory Consultant
If you have a device that will require a 510(k), clinical efficacy testing, or other burdensome and costly components, you will probably want to engage a regulatory consultant who can advise you on the scientific, technical aspects of your product. Here your FDA legal counsel can provide recommended contacts.
Joe was not that far down the line. He was a scrappy startup, with an idea, and no idea about the regulatory consequences of his nice email to the FDA.
It reminds me an old movie, Defending Your Life, in which Albert Brooks is asked, in the space between worlds: “And what were you in your past life?” Brooks, who is seen in the flashback running while being chased by some prehistoric beast, says: “Dinner.”
When it comes to strategy at the outset of a venture, contact our FDA legal team for insight and guidance.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
