By Curtis Walcker, M.S.
April 12, 2015
I am not sure how many times over the years I have heard dietary supplement industry problems explained away as rare situations involving “bad actors” or a “few bad apples”. Of course these expressions are coming from those within the industry. And although it might be easy to sort of mindlessly accept the notion that the vast majority of dietary supplement companies are in full compliance with the regulations, it may not be realistic. That is not to say all non-compliances exist intentionally, but the industry certainly has more bad apples than many of us care to admit.
One easy way to support this assertion is to look at the Warning Letters sent to dietary supplement companies. Looking at just the most prevalent violation type by number of Warning Letters issued, which is for products being claimed to treat or cure disease (unapproved new drugs), it does not take much to see a major problem. Of the 19 Letters issued to dietary supplement companies so far in 2015 – which is a lot at this point – 18 were going too far with their claims.
The FDA must be credited with keeping on top of the clever tactics being used for product marketing, especially on the internet. Here are the number of companies cited for disease claims violations in the various areas that the FDA is looking:
Website – 16
Brochures / flyers – 6
Product names – 3 (This one should be cited far more often)
Testimonials – 3
Facebook – 3
Meta tags – 2
LinkedIn – 1 (Take note, this is a new area being cited)
Books / e-books – 1
Now if you were not taken aback by 18 companies marketing their dietary supplements in ways that cause them to be viewed by the FDA as unapproved new drugs, and seeing the number of places disease claims are being made, then have a look at this. Below is a list of the diseases supposedly being treated by these 18 companies. It should be noted that this list could actually be expanded, but for practical purposes, some diseases have been generalized and combined.
ADD/ADHD, AIDS / HIV, Allergies, Alzheimer’s disease / dementia, Anemia, Angina, Anorexia nervosa, Antimicrobial, Antipsychotic, Anxiety / nervousness, Arrhythmias, Arthritis, Asthma, Atherosclerosis, Autoimmune, Blood pressure, Brain damage, Cancer, Celiac disease, Cholesterol, Chronic fatigue syndrome, Circulation, Clotting, Cold / flu / other URI, Colitis / UC / IBD, Combats aging (implying disease), Convulsions, Cough, Crohn’s disease, Cuts / Wounds / Burns, Diabetes, Diverticulitis, Down syndrome, Dysentery, Dystonia, Earache / ear infection, Effects of alcohol, Encephalopathy, Epilepsy, Erectile dysfunction, Eye pain, Fever, Fibromyalgia, Gallstones, GERD / heartburn, Gout, H1N1, Hansen’s disease, Hashimoto’s disease, Headache / migraine, Heart diseases (other not listed), Hodgkin’s lymphoma, Hypoglycemia, Irritable bowel syndrome, Immune, Inflammation, Kidney diseases, Leprosy, Liver diseases, Lou Gehrig’s disease, Lung diseases, Lupus, Lyme disease, Malaria, Menstrual problems, Multiple sclerosis, Muscle spasms / cramps, Neuralgia /neuropathy, Osteoporosis, Pain, Parasites, Parkinson’s disease, Prostate diseases, Rheumatic fever, Sarcoidosis, Schizophrenia, Seizures, Sickle cell, Skin diseases, Sexually transmitted diseases, Sterility / Fertility, Strep throat / sore throat, Stroke, Swelling, Thalassemia, Tinnitus, Tissue repair / wound healing, Tooth disease / oral health, Tuberculosis, Ulcers, Urinary tract diseases, Vision diseases, and Wilson’s disease.
If you wondered which of these diseases companies were claiming to be able to treat with their products most often, here is the breakdown by number of companies:
Inflammation – 8
Cancer – 8
Arthritis – 7
Diabetes – 6
Blood pressure – 6
Pain – 5
Cholesterol – 5
Antimicrobial – 5
Asthma – 4
Since it is generally a bad practice to point out problems without bringing some solutions, here are three quick tips you can use right now to begin cleaning up your marketing claims and hopefully avoid an FDA Warning Letter for them.
- Remove all explicit claims. The FDA most often points out explicit disease claims, rather than implied disease claims.
- If you are marketing a product in one of the nine categories listed above (cancer, inflammation, pain, etc.), make those products your priority for cleaning up claims.
- Learn the codified definition of disease, as well as the criteria for structure/function claims, and refer to both frequently.