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Integrator Advisor Speaks: Levin Looks at the Definition of "Quality" in the FDA's cGMP PDF Print E-mail
Written by John Weeks   

Integrator Adviser Levin on Dietary Supplements and the FDA's cGMPs: What  Defines "Quality?" - a Second Look

Summary:  Integrator adviser Michael Levin continues with his analysis and commentary on the current Good Manufacturing Practices (cGMPs) finally published by the US Food and Drug Administration. In this take, Levin looks at how the industry and the FDA have defined "quality" and finds out they are not aligned. What does this mean for practitioners and consumers? Levin brings it all home for ginger lovers with his analysis of a July 2007 action on imported ginger by a California regulatory agency. He credits the American Herbal Products Association (AHPA) for it's response to the FDA and offers a forecast.
Columnist Michael Levin
The current Good Manufacturing Practices (cGMPs) of dietary supplements published recently by the US Food and Drug Administration continues to generate analysis and controversy regarding its ultimate impact. The American Herbal Products Association, for example, petitioned the FDA to amend the rule. This is the third in a series of columns by Integrator advisory board member Michael Levin. Levin is an industry consultant who has served as an executive for both Big Pharma and dietary supplement firms.

initial column on the cGMPs took a first look at the quality issue. His second column analyzed the likely impact of the regulations on the natural products industry.


The FDA’s New Dietary Supplement GMPs: What Is "Quality" - Take 2

- Michael D. Levin, Health Business Strategies

The dietary supplement industry has defined “quality” in several ways. Perhaps the most consumer-relevant definitions revolve around these three attributes: 

  • authenticity  - the ingredients are exactly what is claimed on the label)
  • potency - the amounts specified on the label are exactly the amounts contained in the product) and
  • pure  - the product is contaminant-free. 

So, a product is “high quality” if it’s authentic, potent, and pure, right?
Wrong. FDA disagrees.

In fact, in their Final Rule, FDA has defined “purity” in such a way that a dietary supplement can be “100% pure” and “contaminated” at the same time. Huh?

Rather than define “purity” in terms of an absence of contaminants, FDA, on page 199, defines “purity” thusly:
“(Purity) refers to that portion or percentage of a dietary supplement that represents the intended product”.
Under this definition, it is, therefore, quite legal to claim and advertise calcium carbonate tablets as “100% Pure Calcium Citrate”, when, in fact, the product contains heavy metals (e.g., lead) in amounts that violate California Proposition 65's strict limits for carcinogens and reproductive toxins. (Prop 65 requires a warning on product labeling if the product contains hazardous ingredients in amounts identified by the State of California to cause cancer or reproductive toxicity. For a brief overview, visit this site.)
In their intent to provide
the industry with flexibility
and avoid burdensome
quality mandates, the
cGMPs simply do not
assure “superior quality”.

Side-bar for Ginger lovers

On July 29th, California Department of Public Health (CDPH) – not the FDA -  issued a warning to consumers not to eat fresh ginger imported from China because some batches contained residues of aldicarb sulfoxide, an illegal pesticide found in products sold through Albertsons and Save-Mart stores.  Says the CDPH:

"Symptoms of aldicarb poisoning in humans are likely to occur within the first hour following exposure. Ingestion of foods contaminated with aldicarb at low levels can cause flu-like symptoms (nausea, headache, blurred vision) which disappear quickly, usually within 5 or 6 hours. However, at higher levels, ingestion of aldicarb contaminated food can also cause dizziness, salivation, excessive sweating, vomiting, diarrhea, muscle stiffness and twitching, and difficulty in breathing."
Individuals who may have consumed this product and have any of the above symptoms should contact their health care provider immediately.


That a cGMP-compliant “100% Pure” dietary supplement can be a carcinogen or cause birth defects may seem odd, but it is a logical legal approach that is consistent with other food regulations. In 2005, for example, 100% Pure Florida Orange Juice produced by Orchid Island Juice Company was recalled due to salmonella contamination. It was pure. But it was not free from salmonella contamination.

Bottom Line: “Pure” does not mean freedom from contamination.

So, what then, is “quality”? FDA defines quality (page 34) as meaning:
“ ... that the dietary supplement consistently meets the established specifications for identity, purity [as defined above], strength and composition and has been manufactured, packaged, labeled and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3) and (a)(4) of the Federal Food Drug and Cosmetic Act.”
Under the new cGMPs, the manufacturer must define specifications for:
“ ... identity, purity, strength, composition and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement” (page 774).
Manufacturers, therefore, have the flexibility to define quality by the specifications they choose for their products. Analytical testing is expensive. Some companies may choose to “specify” extensive testing on all incoming raw materials, looking for solvent residues, pesticide residues, etc. Many won’t. Many will rely upon the suppliers Certificate of Analysis. Just as Pharma relied upon the Certificate of Analysis that accompanied the Chinese glycerin which contained the economic adulterant, diethylene glycol, (aka “DEG”, sourced from Iran) which FDA reports in 2006 caused more than 40 deaths in Panama. As a result, FDA commented that the Certificates of Analysis were fraudulent and issued guidance to Pharma to test for the presence of DEG in glycerin on incoming batches of glycerin.
The Good News:

There is excellent work
being done by certain
organizations like AHPA
who have already petitioned
FDA to amend the final rule.


Yes, this is the same DEG recently reported in imported toothpaste.

At a recent presentation, I urged industry to define their specifications as if the future of the industry depends on it. Because, it does.

The Good News: There are some great, high minded companies, committed to quality leadership. Where cost-effective test methods exist to assure authenticity, potency and maximum freedom from contamination exist, they use them, consistently. They embrace their responsibility as “guardians at the gate” to ensure that their health promoting products contain exactly what they should and don’t contain what they shouldn’t. They know, as Pharma was told by FDA, that Certificates of Analysis can’t always be trusted.

And there is excellent work being done by certain organizations who have already petitioned FDA to amend the final rule, requesting, (AHPA, for example) that suppliers of dietary ingredients (the active ingredients in the supplements themselves) NOT be excluded from this final rule (yes, ingredient suppliers are exempted from this rule!)

Forecast: Competition in the industry will increasingly be done on the battlefield of quality. As this matures, consumers will become more educated and empowered to make more informed choices. Prices for “high quality” supplements will increase. FDA forecasted price inflation resulting from the cGMPs– I agree.

In the meantime, consumers will purchase “100% Pure” supplements, cGMP-compliant as well as third-party “certified”, that may still violate California Prop 65 limits. And the higher quality, more extensively tested and more expensive product, may languish on the shelves because consumers just cannot discern the quality difference between the two. In their intent to provide the industry with flexibility and avoid burdensome quality mandates, the cGMPs simply do not assure “superior quality”.

Consumer education is the answer. Caveat Emptor.
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