The war for health supplements heats up
The cost of Phentramin-D, the fast-rising, safe, nonprescription weight-loss pill might steeply increase if Senator Dick Durbin’s Dietary Supplement Labeling Act (S 1310) is approved into law. The bill would basically would compel natural health supplement manufacturers to be subject to costly FDA testing, comply with new labelling regulations (like “For Adults Only”) and duke it out with the big drug makers who have the money and cozy relations with an FDA that has proven to be hostile to supplements.
This is because one of Phentramin-D’s two active ingredients, Methylhexanamine — or geranamine, from geranium oil — is considered a dietary supplement.
Once the bill is approved, existing dietary supplement manufacturers may have no choice but either to comply, raising the prices of dietary supplements in the process, or close up shop altogether, since they would not be able to compete with the likes of, say Johnson & Johnson, Pfizer or Roche.
The bill is reportedly made in response to the Lazy Cakes incident, where melatonin-laced brownies for adult use to counter insomnia were sold to children. This illegal action by one company is being used to limit people’s access to dietary supplements.
What is at stake here is the people’s right to decide for themselves how best to take care of their health. Consequently, their choice of health supplements will be drastically reduced, steeply raising supplement prices — and healthcare costs. Thousands, if not millions, of people in the health supplement industry will also stand to lose their jobs. And, just like software patents hindering software innovation, this bill will also slow down innovation in the dietary supplement field.
Remarkably, parts of the Durbin bill doesn’t really come up with regulations and powers the FDA doesn’t already possess. Parts of the bill duplicate what the FDA already does under the provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the Fair Packaging and Labeling Act, the Nutrition Labeling and Education Act, and Good Manufacturing Practices guidelines.
Add to that, the Durbin bill was launched on the same day the FDA announced its “Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” — “just guidelines,” that, if not blocked, will subvert everything that the DSHEA stands for.
It is an understatement, then, that S. 1310 is so unpopular with the health supplement industry. If no action is done to prevent that bill and the new FDA NDI guidelines, Phentramin-D — and a lot of other health supplements — might not be around for a little while longer.