It has come to my attention from Dr. Harriett Hall's article on Protandim (via Protandim Watch) that LifeVantage second patent application may break the FDA's law. The part that I'm looking at is the following quote on page 28 of the patent application:
"The compositions of the present invention are useful to prevent or treat the following disorders and diseases: memory loss; Parkinson’s disease; aging; toxin-induced hepatotoxicity, inflammation; liver cirrhosis; chronic hepatitis; and diabetes due to cirrhosis; indigestion; fatigue; stress; cough; infertility; tissue inflammation; cancer; anxiety disorders; panic attacks; rheumatism; pain; manic depression; alcoholic paranoia; schizophrenia; fever; insomnia; infertility; aging; skin inflammations and disorders; alcoholism; anemia; carbuncles; convalescence; emaciation; HIV; AIDS; immune system problems; lumbago; multiple sclerosis; muscle energy loss; paralysis; swollen glands; ulcers; breathing difficulties; inflammation; psoriasis; cancer (e.g.; prostate cancer, lung cancer and breast cancer); pain; cardiovascular disease (e.g.; arteriosclerosis and atherosclerosis); ischemia/reperfusion injury; anxiety; attention deficit disorder; leprosy; arthritis (e.g., psoriatic arthritis; ankylosing spondylitis; and rheumatoid arthritis); hemorrhoids; tuberculosis; high blood pressure; congestive heart failure; venous insufficiency (pooling of blood in the veins; usually in the legs); sore throat; hepatitis; syphilis; stomach ulcers; epilepsy; diarrhea; asthma; burns; piles; sunburn; wrinkles; headache; insect bites; cuts; ulcers; sores; herpes; jaundice; bursitis; canker sores; sore gums; poison ivy; gastritis; high cholesterol; heart disease; bacterial infection; viral infection; acne; aging; immune disorders; dental caries; periodontitis; halitosis; dandruff; cardiovascular disease (e.g., hypertension; thrombosis; arteriosclerosis); migraine headaches; diabetes; elevated blood glucose; diseases of the alimentary canal and respiratory system; age-related physical and mental deterioration (e.g., Alzheimer’s Disease and age-related dementia); cardiovascular disease; cerebral vascular insufficiency and impaired cerebral performance; congestive symptoms of premenstrual syndrome; allergies; age-related vision loss; depression; Raynaud’s disease; peripheral vascular disease; intermittent claudication; vertigo; equilibrium disorder; prevention of altitude sickness; tinnitus (ringing in the ear); liver fibrosis; macular degeneration; asthma; graft rejection; and immune disorders that induce toxic shock; bronchpulmonary disease as cystic fibrosis; chronic bronchitis; gastritis; heart attack; angina pectoris; chronic obstructive pulmonary disease; kidney damage during coronary angiography; Unverricht-Lundborg disease; pseudoporphyria; pneumonia; and paracetamol hepatotoxicity."
This immediately reminds me of the quote from the FTC warning about scams that I referenced here: Protandim, Miracle Claims, Scientific Breakthroughs, and the FTC:
"Miracle products claim to cure serious conditions — often conditions that science has no cure for, like arthritis, diabetes, Alzheimer’s disease, multiple sclerosis, cancer, and HIV-AIDS. Some products even claim to be a ‘cure-all’ for several diseases and a host of symptoms. Often, the ads claim the products come with money-back guarantees. Unfortunately, these products, devices, and treatments often are unproven and useless, making promises they can’t fulfill."
It appears that every single one of the conditions that the FTC warns about is in the list. Even more interesting is that several conditions such as cancer, gastritis, cardiovascular disease, asthma, infertility, and diabetes are listed more than once. The patent lists "aging" three times (Fountain of Youth, anyone?).
It is interesting to read "The compositions of the present invention are useful to prevent or treat the following disorders and diseases:" and then find on LifeVantage's own FAQ: "Protandim is not intended to diagnose, treat, cure, or prevent any disease." Clearly LifeVantage is confused about the intentions of its own product. One has to ask the question why should consumers have any trust in LifeVantage or Protandim when the company clearly doesn't know what their own product is intended to do?
Where does this patent perhaps break the law? Well section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) says that drug is defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals." From the words in the patent, LifeVantage views Protandim to fit the FDA's definition of being a "drug."
However, for such claims to be made, the product itself must be approved by the FDA through a process called the New Drug Application (NDA). To the best of my knowledge (and any doubters feel free to prove otherwise), LifeVantage has NOT filed with the FDA to classify Protandim as drug.
It seems one could view this patent application as violating the FDA's laws regarding dietary supplements (which is what Protandim is classified as).
Originally posted 2011-06-18 21:22:03.This post involves: