FDA and False Advertising on Product Labels?
Hi Dr. Rassman. You’ve talked about the FDA cracking down on “false advertising” in the past, specifically on labels. I was wondering why Head and Shoulders can put on the front of their bottle “Improves Hair and Scalp Health Guaranteed”. This is a loosely based statement lacking specifics; i.e. how it improves my hair or scalp health. I can understand it clearing up dandruff, hence improved scalp health, but hair?
People may associate improved hair health with thicker, stronger hair which I believe no magic shampoo has been factually proven to do so.
I asked FDA consultant Norman F. Estrin, PhD, Managing Partner at Estrin Consulting Group LLC, to answer this one. The following response was what he sent me —
“Improves Hair and Scalp Health” is a claim that the FDA would call “puffery”. Puffery is allowed for cosmetic claims. You correctly pointed out that it is a loosely based statement lacking in specifics”. This is characteristic of puffery. It just as easily could have said “livens up your hair” even though we all know hair outside the body is not alive.
Head and Shoulders is an OTC drug because it treats dandruff. It is also a cosmetic as well and its cosmetic claims are regulated by the FDA Office of Cosmetics and Color Additives, while the drug claims are regulated by the Center for Drug Evaluation and Research (CDER). The Federal Trade Commissions also monitors fraudulent claims, especially in advertising. Here are some other examples of puffery:
- Best shampoo ever!
- Energizes your hair
- Eye awakening
- The skin you want
- Safeguards your beauty
- Age Control
- Helps restore youthful zones
- New life for your hair
Since these claims are qualitative descriptions rather than hard facts, the FDA cannot regulate such claims because they are so hard to define. If, however, a cosmetic company claimed “Proven to increase collagen synthesis”, the cosmetic company would be in trouble because any product that does so would meet the FDA definition of a drug:
“(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
(B) articles (other than food) intended to affect the structure or any function of the body of man or other animals”
In this example, increasing collagen synthesis in the body would be an effect on the “structure or any function of the body of man”.
To expand– chemicals that do not make any claim to affect a disease or change the structure of the body are not classified by the FDA as drugs. If intended for cosmetic use ( per the FDA, “for cleansing, beautifying, promoting attractiveness, or altering the appearance”), such cosmetics do not have a premarket approval system by the FDA (except for color additives). In contrast, all drugs require premarket FDA approval, whether by prescription or over-the-counter…and a more stringent requirement for labeling (as they are approved to affect a disease or body structure).
Cosmetics can not advertise in a way that moves them into a category where they are considered drugs. For example, in 1994, the FDA permanently enjoined “Solution 109 Herbal Shampoo” and “Solution 109 Herbal Cosmetic Scalp Cleanser†from advertising that they prevented hair loss (which would have required the level of evidence for drugs) rather than a cosmetic claim of making hair appear fuller or thicker.
Interestingly, an antidandruff shampoo is both a cosmetic and a drug (as it makes the claim to treat dandruff and must provide evidence of such). However – a shampoo such as Nizoral (ketoconazole) shampoo – that some people feel may have some effect on slowing hair loss – has not had any data submitted to the FDA related to such a claim – and thus can be marketed only for excessive dandruff and seborrheic dermatitis of the scalp.