Since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994, companies that manufacture, pack, label or hold dietary supplements have been required to conform to conventional food cGMP. Dietary Supplements now have their own set of standards.
We found several specifics in this ruling that warrant discussion:
-The final rule goes into effect one year from publication date for large companies (defined as 500 or more employees) and two years from publication for small companies (defined as less than 500 employees) and very small companies (defined as less than 20 employees) will have three years.
NCI: we are disappointed with the length of time the smaller companies have to conform. In our view, they should have been adhering closely to the standards for medications already, which are even more stringent than these cGMPs.
-The rule is relevant to all dietary supplements sold or offered for sale in the United States, so that even foreign firms will be required to meet the new manufacturing identification standards.
NCI: this is fine. Manufacturers must identify every ingredient with 100% certainty. However, this still leaves it up to the manufacturer to create its own quality control measures to ensure the safety of raw materials. Raw material suppliers are exempt from these cGMPs. There is a lot left to be desired from raw materials coming from abroad. The adverse reaction reporting system that was passed earlier this year will help with safety, but a set of ironclad safety guidelines for all to follow could have been placed in this ruling. Now, instead of acting as a preventive, safety will still be reactive.
-FDA will "exercise enforcement discretion" with regard to products made by practitioners, such as acupuncturists and herbalists who use the products that they make in a "one-on-one consultation."
NCI: we are very encouraged by this development. There is very little attention paid to supplements manufactured by practitioners, pharmacies, and custom vitamin formulators. However, oversight of this regulation will take a "Herculean" effort.
-Requires a qualified person to investigate any ''product complaint'' that involves a possible failure of a dietary supplement to meet any cGMP requirement, with oversight by quality control personnel.
NCI: Once again, noble, but impossible to enforce in the FDA's current state. Look at the deplorable track record they have had with addressing food and drug infractions/safety.
A colleague was on the FDA press conference call the day the cGMPs were released, and he asked if the agency currently has the resources and personnel to effectively enforce the GMP requirements.
The answer was that this will become a part of the agencies overall enforcement strategy which bases resource allocation on potential risk.
When he asked what level of risk the agency believes exists in the dietary supplement sector, the response was that the agency does not really know yet.
We've been saying it all along, but will say it again. If the agency does not enforce the cGMPs, then this will only make the playing field even more unlevel. And we have serious doubts that this will be accomplished.
Another crucial issue that was not addressed in this ruling: there are still no regulations that require supplements to carry adequate directions for use and appropriate warnings.
If you read this newsletter, most likely you have put your nutritional care in the hands of Nutritional Concepts. Why should this put you at ease?
- 25 years of clinical and public health experience with nutritional supplements.
- Many manufacturers that we work with adhere to the cGMPs required of drug manufacturers, which exceeds the new cGMPs set for the dietary supplement industry.
- Having prescribed the same dietary supplements for 10 to 20 years, a track record of safety and reliability has been established.
- We go beyond the cGMPs and ask our manufacturers to provide us with data on their raw material suppliers. We do this to confirm that our manufacturers are consistently checking their raw materials for impurities, toxins, and place of origin.
- Your nutrient needs have been individualized to your unique needs, going far beyond any recommendations that could be made on a label or by a store employee.