Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products.
Here are some glimpses into the regulatory behemoth that can make a meal of your planned market victory — and some strategies to navigate the regulatory labyrinth and bring your product to market.
Bobby’s Body Cream
Bobby has formulated a body cream that gets applied to a proprietary bandage which you then wrap around your waist–and presto! “pounds just melt away.”
Wrinkles also “vanish.”
If only it were that easy.
Does Bobby have a cosmetic or a drug?
What’s in a claim?
FDA looks to intended use of the product.
Intended use is shown by labeling, which includes not only the product label, but everything “appended” to the label, including online marketing (such as claims on the website).
Cosmetics are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
- skin moisturizers
- fingernail polishes
- eye and facial makeup preparations
- permanent waves
- hair colors
- components of a cosmetic product.
Drugs are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Some products can meet both definitions–for example, when a product has two intended uses.
Think about a shampoo that also is claimed to be “anti-dandruff.”
Ways to show “intended use”
There are at least 3 different ways to find an “intended use” as a drug.
First, claims on product labeling. For instance, “antiperspirant.”
Second, consumer perception. The product may have a reputation in the market as one that cures or treats disease.
Third, ingredients. Some ingredients may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. For example, fluoride in toothpaste.
Some common drug claims in products that companies think they are marketing as cosmetics, include:
- “acne treatment”
- “dandruff treatment”
- “hair restoration”
- “increase production of collagen … fewer wrinkles”
- “reduce inflammation”
- “boosts gene activity”
- “gives you the same results as injections or surgery!”
- “treats acne”
- “treats eczema and psoriasis”
Back to Bobby’s Cream
Bobby does not have a dietary supplement, because his product is intended to be applied topically, and not to be consumed by mouth.
Bobby cannot make claims about removing wrinkles, as these are drug claims. FDA warns in Wrinkle Treatments and Other Anti-Aging Products:
So, if a product is intended, for example, to remove wrinkles or increase the skin’s production of collagen, it’s a drug or a medical device…
FDA is concerned about drug claims made for products marketed as cosmetics, such as skin care products with anti-wrinkle or anti-aging claims that involve supposed effects on the structure or function of the skin.
Weight loss claims can put Bobby on the FTC red flag enforcement radar. Although some weight loss claims are acceptable, claims about pounds “melting away” are likely to trigger enforcement scrutiny.
FDA also tends to target unsupported weight loss claims, and has a page on weight loss fraud. FDA gives consumers tips for spotting fraud – and these are also a good checklist for marketers.
For example, don’t:
- Say: “You want quick easy weight loss, without diet or exercise? Look no further! We have the one and only product that is guaranteed to work!’
- Dress up like a doctor in an ad for the weight loss product.
- Promise a magical pill.
- Promise an “instant fat dissolver.”
- Use a phrase such as “lose it overnight!”
- Use words such as “guaranteed” or “Scientific Breakthrough”
Regulators don’t get excited
And they don’t like exclamation marks, apparently.
SO by all means, from a marketing perspective, generate excitement; but don’t use overstatement to market your product!!!!
(exclamation marks are for emphasis – lose them during the promotion)
Both FDA and FTC will tell you that if you want to lose weight, you’ve got to move and groove, and/or eat and drink fewer calories. No product will do the work for you.
Some FDA and FTC action against “dream creams”
FTC brought charges against companies marketing their creams as “cellulite fighters ‘proven’ to sculpt up to 1.3 inches from the thighs and slim the body in just 4 weeks.”FTC noted: “You won’t sculpt your body with a miracle cream.”
An FTC settlement prohibited one manufacturer from “making false claims that a food, drug, or nutritional supplement helps users achieve or maintain weight loss without diet or exercise.” FTC also barred “unsubstantiated weight-loss, weight-loss maintenance, cholesterol-reduction, or other health-benefits claims for such products.”
FTC sued marketers for falsely advertising that “BodyFlex causes fast inch loss and fat loss.” The false claims included:
- BodyFlex causes users to lose from four to 14 inches across six body areas in the first seven days without reducing calories;
- BodyFlex causes users to burn enough body fat to achieve the claimed inch loss in seven days; and
- a clinical study proves that BodyFlex causes significant fat and inch loss in the first seven days.
FTC sued marketers of an ab belt:
… the marketers advertised “Ab Force” using visual images of well-sculpted, gym-clothed bodies wearing the Ab Force device, with verbal references to other, more expensive ab belts that were sweeping the nation at the time. The FTC alleged that through the product name, text and visual images, and by comparing their product to “those fantastic electronic ab belt infomercials on TV,” the defendants made false and unsubstantiated claims about the product’s abilities.
These are all variations on a theme of unsubstantiated claims.
What’s in a regulatory definition? Market barriers, market opportunities
The real challenge for the manufacturer of a cream or other consumer product for someone like Bobby is to keep regulatory barriers to market entry as low as possible.
This is where legal strategy meets marketing.
Bobby’s company probably is financially unprepared for the huge costs and large amount of time required to bring a drug to market.
Cosmetics, on the other hand:
- ordinarily do not require premarket approval to get to market
- do not require establishments to register with FDA
- have lighter requirements for manufacturing practices (i.e., cannot be adulterated or misbranded, but are not subject to GMPs
- have different labeling requirements
Cosmetics are much easier to bring to market.
Some legal strategy for Bobby
Cosmetic or drug? Claims matter for body sculpting and slimming products.
Here are some legal strategy points for Bobby:
- limit the number of claims he makes for his creams
- work with legal counsel to create proper cosmetics claims
- understand that disease claims can arise from not only obvious mention of disease, but also from claims that talk about altering the structure or function of the body
- look to FDA labeling guidance for cosmetics products as some of this is DYI
- consider a long-term strategy that could involve an OTC drug and therapeutic claims – with the right innovation partner, research, and funding
An initial consult with an FDA attorney could go a long way to help Bobby sort through his marketing materials and create a proper legal strategy to market.
Long-term, Bobby should review his marketing and legal strategy as his market share increases, and temptations arise to say more, faster, to up his sales.