The advertising and marketing of OTC homeopathic products will come under increased scrutiny this Fall, when the Federal Trade Commission hosts a workshop to examine shifts in the market and potential revision of regulations.
In the wake of the New York Attorney General's regulatory action earlier this year, herbal product retailers now face a whirlwind of class action lawsuits.
First there was categorical dismissal: Gluten allergies are “psychosomatic,” leaky gut syndrome is a made-up diagnosis, and celiac disease is a rare condition you might encounter once or twice in your medical career.
Then, begrudging acknowledgment: Mayo Clinic researchers note that nearly 2 million Americans—and 1% of the Caucasian population-- likely have celiac disease.
And now, the latest phase in mainstream medicine’s long, strange relationship with gluten-triggered disorders: a big pharma gold rush.
Indeed, drug developers have finally caught on to what food marketers recognized 15 years ago: there’s a huge number of people whose chronic digestive problems are –or could be—related to gluten sensitivities, and who are desperate for meaningful solutions
According to a recent New York Times article, several pharma companies are scrambling to be first to market with a drug solution to the celiac equation. All are still in early-stage development, and no actual drugs are expected to emerge until 2018 at best.
Alvine Pharmaceuticals, a small, privately-held drug company based in San Carlos, CA, has been working on a formula known as ALV003 that contains two enzymes that—at least in principle—break down gluten into non-allergenic fractions before it ever reaches the intestines.
AbbVie, a Chicago-based pharma development company with revenues of $18.8 billion in 2013, recently paid $70 million to Alvine for an option on the global rights to ALV003.
Alba Therapeutics, a Baltimore company, has been working on a drug called larazotide acetate that blocks gluten from slipping through the tight junctions between epithelial. In other worlds, it purports to treat one of the key features of that once-imaginary leaky-gut syndrome. Alba was recently acquired by global drug giant, Teva Pharmaceuticals.
The FDA has clearly taken note of the gluten-drug bonanza. Late in March the agency held a day-long workshop entitled Gastroenterology Regulatory Endpoints & the Advancement of Therapeutics (GREAT), focused on scientific issues around establishing and measuring meaningful endpoints in celiac disease, irritable bowel syndrome, and oth related conditions.
Ain’t it funny how a condition can go from “imaginary” and “psychosomatic” to significant and worthy of serious investment, as soon as someone sees a large and lucrative market?
Federal investigations into potentially fraudulent business practices by Health Diagnostic Labs and four other widely-used cardiovascular testing labs has prompted major lawsuits, corporate shake-ups, and physician indictments. Here's how to avoid getting caught up in the fray.
Badenya, an international cultural organization founded by writer & educator, Kewulay Kamara, is raising funds to help families in northern Sierra Leone survive the Ebola crisis.
It may sound like a satire right out of The Onion, but its the honest truth: a Bellevue, WA-based company called mCig is trying to get people to inhale their vitamins.
The company's VitaCigs are $5 devices based on the same vaporizing technologies used in "e-cigs." The difference is that the VitaCig delivers inhalable, vapor-based, nicotine-free vitamins and phytonutrients. These "phytonutrients" include compounds derived from cannabis, but not THC, and in its annual report the company notes that VitaCigs provide "some of the effects that the marijuana plant provides, without the THC-induced high.
The same group does produce a separate line of cannabis mCigs for states in which recreational marijuana has been legalized.
The company claims to be "simultaneously disrupting Big Tobacco and Big Pharma," by providing the world's 1.2 billion smokers with a smoking alternative that is decidedly less harmful. Though the company makes no specific health claims for its vita-vapes, the very notion of delivering vitamins in vapor form seems to imply that the product creates a healthy habit.
Whether this is true remains to be seen. The concept of inhaling vitamins is new, and while in theory it is possible that some vitamins may be absorbable via the lungs, this mode of delivery has not been seriously studied. Little is known about dosing of inhaled vitamins, bioavailability, or bioequivalence with standard oral dosing.
VitaCig's "VitaJuice" formulas bear names like "Energize," "Calm" and the like. The manufacturer notes that "Every VitaCig includes the following base vitamins A, B, C, E and CoQ10." To this base are added flavorings and additional nutritional components alleged to enhance the intended effect of the formula.
For example, the "Grace" formula--presumably for joint health and balance--is supposed to contain "Mint plus cherry and collagen," while the "Relax" formula contains "Blueberry plus Black Currant and B-Myrcene, a natural turpene."
With it's clean yet colorful graphics, VitaCig is definitely going after a youthful customer base, one that is equal parts health- and fashion-conscious. Since its launch roughly a year ago, VitaCigs have generated just over half a million dollars in revenue--a modest figure given the billions in revenue projected by the Big Tobacco firms that have largely taken over the e-cig market. But company CEO, Paul Rosenberg, says that 21% of its current 30,000 customers are repeat users, and that VitaCigs as well as the eCig industry as a whole are still in their infancy.
In addition to the scientific questions around the biology of inhaling vitamins, the emergence of the VitaCig poses some significant regulatory questions: Should it be regulated as a dietary supplement? A medical device? A drug delivery system?
Like so many other new developments at the crossroads of technology and healthcare, this one defies easy categorization.
rrently in four formulations: