We’ve written before about the murky territory that exists between drug manufacturers and pharmacies. It’s a great example of how distinctions that once made sense can fail to address changed circumstances or the cleverness of people who like to game the system. Right now here in federal court in Boston, one of the principals of the infamous New England Compounding Center is on trial for second degree murder — that’s right, murder — for his role in the scandal that led to two dozen deaths.
Laws changed because of what that case revealed: that industrial-sized drug repackagers and compounders were posing as pharmacies, subject only to state pharmacy regulations, even though they were not really pharmacies but drug manufacturers anxious to avoid federal oversight. Today, the federal Drug Quality and Security Act and the Compounding Quality Act make such gamesmanship far more difficult, and allow for federal oversight over compounders and repackagers who are handling drugs on an industrial-scale basis. One change: the “cGMP” standards (short for “current good manufacturing practices”) will now apply. One can no longer hide behind a pharmacy sign and play games with drug products before sending them on to unsuspecting consumers. No doubt lives will be saved as a result of these new laws.
Yet supplements are a similar accident waiting to happen.
Most people know and understand that the Food and Drug Administration (“FDA”) regulates the activities of drug manufacturers and food producers, ensuring that the drugs we take and the food we eat are safe. On the drug side, this means that before a drug can be sold, the manufacturer must satisfy the FDA through a series of rigorous submissions showing that the drug is 1) safe and 2) effective. Detailed labeling requirements allow consumers to have a fighting chance in the effort to understand what they are taking and what the risks are.
The regulation of food is handled somewhat differently, but also has human safety as its paramount object. Two areas are well understood and well justified: inspection and labeling. The FDA has the authority to inspect plants that are engaged in large scale food production. Slaughterhouses, for example, are subject to FDA inspection to ensure that meat is safe and that plant conditions are sufficiently sanitary to avoid contamination. Recalls can result from the FDA’s inspection authority, with the aim of preventing human consumption of unsafe meat. (History buffs may perhaps know that the genesis of the Food, Drug and Cosmetic Act, as it is now known, was the exposure of unsanitary and unsafe conditions in the Chicago meat-packing industry, made vivid in Upton Sinclair’s The Jungle.)
Labeling is another safeguard. Now, given the astonishing amount of additives that go into processed foods, food producers are required to accurately label the ingredients in a processed food package. This, too, gives consumers a fighting chance. If you’re diligent, you can pause and think twice before buying that package whose key ingredient is Red Dye Number 7.
But one secret most consumers don’t understand — but should — is that the FDA’s jurisdiction does not extend to supplements. At least not yet. So consider this a public service announcement. Those products on the shelves that make outrageous claims about enhancements to your body and to your health are mostly supplements and outside the rules that apply to food or drugs. No one has had to prove to the FDA or anyone else that: 1) it is what it purports to be, 2) it’s safe, or 3) that it’s effective in the ways that it claims. Buyer beware!
As we see so often in our whistleblower practice, when rules are unclear, temptation takes over. Last week’s front page story in the Boston Globe provides a sobering glimpse into what’s out there.
Jared Wheat, the CEO of High-Tech Pharmaceuticals, is a twice-convicted drug dealer who thought up the idea for his “High-Tech” drug supplement business while serving time in prison for his conviction for selling ecstasy. In 2003, according to the article, he was again convicted for running an illegal online “pharmacy.” (Sound familiar?) Nonetheless, his company currently grosses $100 million per year by selling dietary supplements with catchy names like Black Widow and Yellow Scorpion. Due to Congressional inaction (and general coziness with industry), there is little that the FDA can do to police the supplement industry, unless provided specific information about safety risks, by people like whistleblowers.
When Harvard researcher Dr. Pieter Cohen began running tests on the products of High-Tech and other companies’ supplements, he found that the supplements contained unsafe levels of certain synthetic compounds and publicly urged FDA to inspect the facilities. He was slapped with a libel suit brought by Wheat and was forced to justify all of his findings in an unpleasant libel trial. Although Cohen won the suit, Wheat unabashedly says that he hopes the hundreds of thousands of dollars he spent on the libel suit will make researchers think twice before publishing their results. The incoming President says he wants to “open up” libel laws to make this type of lawsuit easier.
We’re entering into a political phase where all manner of regulations will be questioned. If people have their eyes open, though, they will urge restraint, because many of the existing regulations are clearly making us safer. (Do we really want to go back to the days portrayed in The Jungle?)
Under a Trump Administration, we should certainly not expect any expansion of regulation into new areas like food supplements. It will remain Caveat Emptor! for the indefinite future, with consumers at a real disadvantage.
Be careful out there!