Why Pharmaceutical Grade Supplements Are Critical

A growing concern among physicians and consumers is whether dietary supplements contain all of the active ingredients listed on the label. This apprehension is based on well-publicized analyses of commercial supplements showing considerable variation in ingredient quality and quantity.

The Life Extension Buyers Club learned a long time ago that there were few ingredient suppliers who can be trusted to consistently deliver pharmaceutical-grade ingredients. That is why the Buyers Club mandates extraordinary quality-control measures in order to guard against the counterfeiting that has become so prevalent in the supplement industry.

An example of misleading products can be found in the prostate-protection formulas now offered by dozens of companies. One of the key ingredients in these products is pygeum, which functions by several mechanisms to prevent and alleviate the effects of benign prostate enlargement. The scientific literature clearly states that 100 mg a day of pygeum is required to produce a biological effect, yet some companies are putting in only 10 mg of pygeum and claiming this small amount will produce a benefit. To make matters worse, the high cost of pygeum extract has motivated unscrupulous suppliers to dilute pygeum with sterols from other plants.

The Life Extension Buyers Club restricts its pygeum purchases to Indena, the premium producer of pygeum (and other botanical extracts). Rather than trust the certificate of analysis that comes with every batch of Indena's pygeum, the Buyers Club assays the material to verify that it meets pharmaceutical-grade standards.

Companies offering low-cost ingredients constantly solicit Life Extension Buyers Club's business. An assay of the ingredients from these discount companies, however, using HPLC (high performance liquid chromatography) or mass spectrophotometry (mass spec), often reveals inconsistencies. This is why Life Extension restricts its purchases of ingredients to nutrient suppliers that take extra steps in their manufacturing process to ensure the active ingredients are of pharmaceutical quality and potency.

Some companies that sell finished dietary supplements attempt to verify ingredient authenticity by using a low-cost method known as the "melting point." The problem with using the melting point test is that counterfeiters can find substances that melt at the same temperature as the real ingredient, thus enabling them to pass on an inactive agent as the legitimate ingredient. The quantitative analysis (HPLC/mass spec) mandated by the Buyers Club verifies not only the potency, but also the purity. If impurities are detected, the quantitative analysis can often identify them.

A Company that Refused to Do Business with Life Extension

A deceptive practice that occurs in the ingredient industry is to submit samples that meet pharmaceutical standards, but not deliver the same high quality material for use in the finished dietary supplement. That is why Life Extension has active ingredients assayed before they go into the bottle.

One company that desperately wanted Life Extension's business guaranteed their quality would meet pharmaceutical standards. This company provided all kinds of impressive documentation and ingredient samples showing they were capable of meeting the Buyers Club's exacting requirements. When Life Extension told the company that acceptance of any shipments would be contingent on the ingredients passing a quantitative analysis (mass spectrophotometry / HPLC) test, the company said they would prefer not to enter into a business relationship.

The Importance of Purity

The Chinese have done the American vitamin consumer a tremendous favor. For decades, European and Japanese companies maintained a virtual monopoly that forced supplement users in the United States to pay inflated prices. The Federal Trade Commission (FTC) even brought an antitrust case against these companies that resulted in them disgorging huge amounts of their profits.

Free markets, however, do not need a government watchdog to protect against price fixing. The outrageous profits generated by the European-Japanese monopoly motivated the Chinese to copy just about every dietary supplement and sell them at sharply reduced prices.

While the quality of these Chinese knockoffs was considered inferior, it forced the Europeans and Japanese to slash their prices in order to remain competitive. The net effect is that the inflation-adjusted prices for dietary supplements have plummeted.

By selling raw materials at sharply lower prices, the Chinese were far more effective than the FTC in reigning in the spiraling cost of dietary supplements.

The Chinese are now inundating supplement makers in the United States with very low-cost materials. The purity of these ingredients often fails to meet Life Extension's standards. For instance, Life Extension was offered a low-cost alpha-lipoic acid ingredient made in China that assayed out at 95% purity. The European pharmaceutical standard, however, is 99.99%. Since alpha-lipoic acid is a popular prescription drug in Europe, Life Extension restricts its purchases of alpha-lipoic acid to European manufacturers. Pharmaceutical-grade ingredients are more expensive, but provide more of the active ingredient and are safer for the consumer to use because they do not contain impurities.

Why the FDA Cannot Fully Protect Consumers

The FDA currently employs less than 10,000 people, yet they are charged with regulating products that account for 25% of the gross national product of the United States. It would be absurd to think that the FDA has the resources to verify that every dietary supplement sold in the United States meets label potency.

Life Extension magazine has reported on serious quality-control problems the FDA has uncovered at certain drug companies. For instance, the FDA found that pharmaceutical giant Schering-Plough was making asthma inhalers that did not have any medication inside. Acute asthma attacks suffocate 5438 Americans every year (National Vital Statistics Reports Vol. 48, No. 11). With no medication in an inhaler, any asthma attack can be lethal. The FDA repeatedly found the same problem with these asthma inhalers (no medicine inside), but it took Schering years to correct the problem. The FDA is making Schering pay a $500 million dollar fine to settle the matter (Wall Street Journal Dec. 24, 2001, A3, "Schering fines could total $500 million"). In 2001, American Home Products paid $30 million as part of a consent decree involving manufacturing defects practices, while Abbott Laboratories paid fines of $100 million in 1999 concerning manufacturing defects in scores of its products.

Since drug company quality-control deficiencies can result in death, the FDA is justifiably spending a lot of resources inspecting pharmaceutical manufacturers. After more than 12 years of neglect, the FDA is also more effectively policing the blood banking industry. The Life Extension Foundation long ago exposed the fact that blood banks were knowingly selling blood contaminated with HIV and hepatitis C, and the FDA was not taking proper enforcement actions.

The FDA's Inspection of Life Extension

In 2000, an FDA inspector showed up at the Life Extension Buyers Club and demanded samples of Life Extension's products for the FDA to assay. The FDA agent was initially extremely belligerent, perhaps expecting a legal challenge to his demand for product samples. Instead, Life Extension's quality-control supervisor provided the FDA with all requested samples but let him know that the identical lot numbers would be sent out to two independent assay laboratories to verify any findings the FDA came back with.

During this initial inspection, the FDA agent repeatedly threatened to imprison Life Extension personnel if any problems were found. Life Extension responded that the products had already been assayed and therefore had no concern about what the FDA would find.

Within 10 days, the assays from the two independent labs came back on all products. Upon showing these, along with file cabinets full of quantitative analysis results, to the FDA inspector, the FDA agent stated he was calling off the inspection because the quality-control procedures employed are analogous to those of drug companies. The FDA inspector indicated that he did not expect that a supplement maker would operate under pharmaceutical quality-control standards. When the FDA agent was asked if the samples taken 10 days earlier met the FDA's standards, he indicated that they were not yet submitted for assay and would not be because the two independent labs had already documented that they met label potency.

Assaying Other Companies' Products

Based on Life Extension's exacting quality control standards, the news media has asked The Buyers Club to assay commercial dietary supplements to verify that the products meet label potency. In April 1999, Life Extension was asked to analyze seven different brands of SAMe by a national news magazine. The results of the assays showed that two of the seven had no SAMe present whatsoever. One brand used the wrong form of SAMe, while two other brands had less than 100% potency. Only Life Extension's and Nature's Made products had 100% of the right form of SAMe. Many consumers who trusted the reputations of some very well-known companies were clearly not getting that for which they paid. (SAMe is not the only product Life Extension has assayed and found that the potency did not meet label claim).

Life Extension's Commitment

When members buy products from the Life Extension Buyers Club, they have assurance that the quality of the product is backed by the organization's commitment to achieving an indefinitely extended lifespan. Members receive large discounts that enable them to purchase premium-grade nutrient supplements at prices below those charged by commercial companies. Many commercial companies are now using lower-grade materials, but Life Extension continues to mandate pharmaceutical-quality ingredients. This enables members to obtain products they can trust and still obtain discounted prices.