Category: policy

FDA Issues Dietary Supplements Final Rule

The FDA issues rules that will finally make dietary supplement manufacturers conform to some rules in the manufacturing of the products.

Which ones?

  1. Accurate potency and labeling – 30 mg glucosamine will now contain something close to 30mg
  2. Impurities Testing – All the raw materials will now be tested for impurities/contaminants. They will probably follow USP guidelines.
  3. Adverse event reporting – Manufacturers/sellers will need to report adverse events. This is after the fact safety testing, wholly inadequate, but better than what we had previously.

See something missing? Efficacy!! You do not have to prove that your product actually works! Basic safety? What is the overdose level? Interactions with other medicines/supplements? Is your dosing form actually bioavailable? Meaning, if you swallow a pill, will it actually get into your bloodstream and reach the intended target?

Who knows, but standardizing, cataloging and auditing manufacturing processes is a start, I guess. 1.5 cheers for the FDA!

I would be curious to find out how these companies are going to get audited by the FDA to prove that they’re following the quality control measures they’re supposed to implement. Guess I have to read the 815 pg bundle of joy that is the actual rule to find out more. A cursory word search on audits suggests that the manufacturers do audits on their suppliers, that the quality control unit of manufacturer perform audits on their manufacturing process, but nothing about the FDA conducting audits. Of course, calling yourself a GMP (good manufacturing processes) manufacturer is usually enough to trigger an FDA audit if you’re in pharma. I wonder how the FDA will deal with this one.

FDA Issues Dietary Supplements Final Rule

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

In Praise of Red Tape

In Praise of Red Tape

Is there any figure in American political discourse more reviled than the bureaucrat? Say the word and a potent caricature leaps to mind: the petty and shiftless paper pusher who wields his small amount of power with malice and caprice. Whatever the issue–from school reform to overhauling the nation’s intelligence apparatus–the bureaucrat is on the wrong side of it.

Hayes makes an argument that I try to make at mixed gatherings everywhere. Unfortunately, I do not make it as coherently as he does. The secret to any functioning government is a good mid-level bureaucracy that has enough technical experience to implement reasonably good policy, but isn’t overly politicized or corrupt. When I was growing up in India, one of the constant refrains was “Why can’t we be like the Americans? You can actually get a driver’s license without bribing someone!”

The DMV (which is low level bureaucracy) still works well in the US (yes, my American friends, try getting a license in India!), but the mid level bureaucracy has gotten overly politicized in its top leadership over the years. This leads to that vicious cycle I have blogged about previously:

  1. Appoint lackey to head agency
  2. Appoint viceroy to oversee regulation
  3. Rewrite rules to increase power of executive over legislative
  4. Shift burden of proof away from the regulated to the regulators
  5. Slash budgets so regulating agencies cannot do the work adequately
  6. Hound competent employees out of the agency
  7. Routinely bash said agency as an example of “big government”

Repeat steps 4-7 as often as necessary to ensure “success”

Well, it appears that the mid-level bureaucrats pushed back, and Hayes catalogs the results.

I leave you with a good truism:

Red tape is what binds those in power to the mast of the law, what stands in the way of government by whim