For an industry that has a far better safety record than highly regulated drugs, the dietary supplement industry has endured over a decade of unfair criticism that it is unregulated, which is factually untrue. For a number of years Title 21 of the U.S. Code has spelled out requirements for dietary supplement labeling and quality. The main difference between food Good Manufacturing Practices (GMPs) and the new ones for the dietary supplement industry is that over and above checking for sanitary and product consistency, the new GMPs spell out requirements for purity, identity and dosage.

But supplement manufacturers were always responsible for ensuring that the "supplement facts" box and ingredient lists are accurate, that the dietary ingredients are safe, and that contents match the amount declared on the label. It’s just that there are no “vitamin supplement cops” that check up on the accuracy of labeling and advertising claims.

Now that GMPs are in force, there is no indication the FDA is going to start testing dietary supplements. The FDA doesn’t test prescription drugs either, though the public has a misconception that it does.

The independent Consumerlab.com, started by former FDA employees Todd Cooperman MD and William Obermayer PhD, may have been a veiled way for government to check up on the accuracy of dietary supplement labels without getting directly involved. Consumerlab says 1 in 4 dietary supplements are substandard.

So the FDA took its time, 13 years, to draft GMPs that still has gaping holes in it. The dietary supplement industry took it on the chin all this time when it was the FDA that hadn’t completed its homework assignment.

Extrapolation of data from the FDAs own GMP document shows this 13-year delay resulted in a lost opportunity to prevent nutrient-related chronic disease, which resulted in hundreds of millions of dollars of avoidable health care costs. However, the FDA GMP document didn’t focus on its own tardiness, but rather claimed issuance of the new GMPs would now reduce costs of chronic disease by an estimated $40 million a year.

Supplement industry ahead of the FDA

The dietary supplement industry wasn’t using the lack of GMPs as an excuse to produce shoddy goods. According to a 6-year old survey published in the newly published GMP document itself, nearly 90% of dietary supplement manufacturers were already following GMP models at the time. However, Consumerlab continues to report the dosage of nutrients found in dietary supplements varies widely from the labeled amount. This says something about the flaws and gaps in relying solely upon GMPs.

The dietary supplement industry has some longstanding problems, namely inaccurate dosage claims on labels and exaggerated or poorly founded advertising claims. Will either of these two issues be resolved by the recent issuance of Good Manufacturing Practice (GMP) guidelines by the FDA? After a review of the FDA’s 854-page GMP document, the answer is no.

The GMP wastes a lot of pages describing sanitation requirements for dietary supplement establishments that are already covered by state regulations, and in outlining measures to prevent bacterial or fungal contamination of dietary supplements, which are not the major problems facing the supplement industry today.

While the GMP document includes an extensive discussion of the pros and cons of each GMP requirement, such as testing of raw materials, it never mentions testing of finished goods, nor validation of the published shelf-life of these products, two critical issues in guaranteeing high quality products for consumers.

The GMP document is naïve. There will be more paperwork, more jobs for consultants, more testing, but will product quality improve?

Real-world testing

Take a real- world example of how supplements are made today. Certificates of analysis of raw materials, such as vitamin powders or herbal extracts, are commonly provided to dietary supplement manufacturers now. The GMPs mandate them. What’s changed? Nothing. The paperwork can all be proper, but in many instances the certificates of analysis provided by raw material suppliers are inaccurate, even forged. Some reports are fabricated by vendors or distributors from foreign countries. Unless the manufacturer conducts testing on its own, there is still no way of knowing if the product provides what its label claims.

Testing finished goods

Testing may confirm the presence, potency and purity of raw materials used in dietary supplements, but the manufacturing process itself may degrade or alter the molecular structure of nutrients. For example, one study shows up to 25% loss of vitamin C during the processing of vitamin C pills. [International Journal Food Science Nutrition 2002: 53(6):509-18] Lycopene and resveratrrol are other dietary supplement ingredients that are subject to molecular alteration by light, heat or oxygen and may be affected during manufacturing. [Journal Medicinal Food 2005 Winter; 8(4):413-22; Aging Cell. 2007 Feb; 6(1):35-43]

The new GMPS, as thorough as they appear to be, may still not guarantee supplements will deliver what is listed on their labels. For example, dietary supplement companies test garlic pills for their potential to produce allicin, garlic’s active ingredient, by placing garlic powder in an alkaline water bath. But the alliinase enzyme in garlic powder, which activates the production of allicin, is degraded by stomach acid, so the test is misleading. When placed in an acidic medium that simulated stomach acid, like vinegar, far less allicin is produced. Only an enteric coated capsule that opens in the upper intestine, away from harsh stomach acid, or a buffered garlic capsule, would yield a reliable amount of allicin. Bottom line, if the wrong test is performed, the label on dietary supplements may be misleading. But the flawed test would comply with GMPs.

FDA’s flawed rationale for GMPS

More disturbing was the rationale the FDA used to justify the GMPs. FDA claimed it found record of over 24,000 adverse events associated with dietary supplements. But this was for a period covering more than a decade, and many were trivial, few were mortal, and even fewer supplements were shown to have a causal relationship to reported side effects.

To further justify a need for the GMPs, the FDA cited a Prevention Magazine study which claimed a strong percentage of the American public does not believe dietary supplements are safe. However, the public formed this opinion from factitious information distributed by the FDA and other complicit agencies and healthcare groups.

More galling was the rationale the FDA used to justify cost effectivenss of the GMPs. As an example it used the prevention of birth defects (spina bidifa) in newborn babies by folic acid to quantify monetary savings produced by dietary supplements when these products meet GMP requirements and accurately provide labeled amounts of folic acid. For the record, the FDA is the very agency that has drug its feet for many years over folic acid supplementation and food fortification, causing thousands of totally avoidable cases of spina bifida.

The FDA claims there will be fewer product recalls with implementation of the GMP guidelines, but this would only prevent an estimated 118 illnesses per year.

The FDA GMP document predicts about 172 small dietary supplement companies will be threatened with going out of business due to the new guidelines. – Copyright 2007 Bill Sardi, Knowledge of Health, Inc.