Nutritional Supplement Quality – The Facts

At the time of this writing, Consumerlab.com does not test products for the presence of solvent residues, however CNCA does conduct such testing. CNCA has rejected raw materials that contained unacceptable levels of toxic solvents. The FDA has identified a small number of solvents as being Class I solvents. Essentially, the Class I solvent means, “This solvent is extremely toxic. Use only if you remove most of it out of your manufactured product before it reaches consumers”. ⁶ Strict limits are defined fro Class 1 solvents.

One of these Class I solvents is 1, 2 DCA (1,2 dichloro-ethane). Because CNCA tests for DCA, one raw material containing five times the FDA limit for this toxic solvent was found. The material was rejected from the manufacturer. The material CNCA rejected to protect its customers from exposure to could have been sold to another company. Do other companies test their ingredients for DCA? Possibly, but it is estimated that very few incur the cost of testing.

Microbiological contaminants are yet another issue. Food contamination with E. Coli⁷ was responsible for the spinach and tomato problems of 2007 and 2008. Samonella contamination of peanut-based products sickened hundreds and killed many people in 2009. These same bacteria can grow in other products, such as herbal medicines. That’s why CNCA, and most other companies, test ingredients and finished products for the presence of these microorganisms before they are distributed to consumers. Tests are reliable and fairly inexpensive to perform.

A more expensive test that few companies regularly perform on herbal ingredients is a test for aflatoxins. Aflatoxins are fungal by-products that are very toxic to the human liver. So toxic, in fact, that FDA has upper allowable limits for aflatoxins in certain food products, such as corn⁸. Aflatoxins have been detected in peanuts, cottonseed, nuts, almonds, figs, spices, and a variety of other foods and feeds.

CNCA found levels of aflatoxins above the FDA allowable limit in Milk Thistle. Milk Thistle is very helpful for supporting healthy liver function. One of its active ingredients is being used experimentally in Europe as an IV drug to treat certain types of liver disease, with very good results⁹. When high levels of aflatoxins were found in this batch of Milk Thistle, we rejected the material and the supplier apologized. They do not test every lot for aflatoxin; they only test a certain percentage of lots (this is known as “skip-lot” testing).

CNCA has every lot tested for these impurities. That’s why CNCA found it, and they didn’t. This lot of material was returned to the supplier. Who else bought this lot of Milk Thistle? Is it still on store shelves today?

The good news is that CNCA proves its commitment by only using proven, ultra-pure ingredients each and every day. CNCA tests for things that other companies, including Consumerlab.com, simply do not.

Contamination of Food and Drugs: It’s important to note that these sorts of problems happen with foods and prescription drugs too. A well-known cereal maker destroyed about 50 million boxes of its popular cereals because an illegal pesticide, chlorpyrifos-ethyl, was found on the oats used to make those products. That cost the company about $140 million ¹⁰. Fortunately, they found it! In the world of nutritional products and prescription drugs, similar situations have been described with the melamine and di-ethyl glycerol (DEG) issues.

But these problems still persist. An Indian-owned, US generic drug company is under FDA scrutiny for repeated violations which include contamination and subpotency of prescription drugs¹¹. The scrutiny has continued for years, with no meaningful actions taken to stop the company until late 2008, when FDA suspended the review of all new drug applications submitted by this firm.

To learn more, the U.S. Government issues a weekly report on product recalls that includes foods, drugs, dietary supplements, medical devices and biologicals. This recall report includes information like how many insect parts are found in cookies, which seafoods were contaminated with drugs and heavy metals, and which over-the-counter cold medications contained metal fragments. Subscribe to product recall notices at www.fda.gov.

Quality Certifications – Do They Go Far Enough?

In an effort to help consumers identify “higher quality dietary supplements”, three “quality certification programs” have appeared in the marketplace.

• Company Programs (most common)
• Product Programs (less common)
• Ingredient Programs (comparatively rare)

While all of the programs are helpful, none covers “all the bases”.

Company Programs: Phrases such as “GMP-Certified” indicate that the manufacturer has voluntarily submitted to a facility inspection by representatives from the Natural Products Association (NPA), United States Pharmacopeia (USP) and/or National Sanitation Foundation (NSF). Company programs look for compliance with elements of “good manufacturing practices” and first began with the NPA (formerly known as the NNFA) about 10 years before the FDA published their final rules on dietary supplement good manufacturing practices. These inspections looked for evidence of GMP compliance in several areas:

• Facility cleanliness, lighting, pest control, etc
• Staff competency and training
• Documentation of Standard Operating Procedures (SOPs) and compliance with SOPs.
• Manufacturing controls
• Labeling controls

Product Programs: Both the United States Pharmacopeia (USP) and the National Sanitation Foundation (NSF) offer programs in which finished products are tested for authenticity, potency and, to some extent, purity. Products that pass this scrutiny have labels that bear the trademarks (“DSVP USP-Verified” and “NSF-Certified”). Participation in these programs are voluntary – and very costly (amounting to tens of thousands of dollars).

However, the programs do not, in CNCA's view, go far enough to assure dietary supplement purity. For example, neither the USP, nor the NSF, requires that all botanicals be tested for the presence of solvent residues. Consequently, a “certified/verified” product could possibly contain illegal levels of the toxic solvent, DCA. CNCA found and rejected a DCA-contaminated botanical ingredient. But under the scrutiny of product programs, the contaminated ingredient rejected by CNCA, could still end up in a “certified” product from another manufacturer.

Worse still is an unfortunate situation in which a “certified” company continued to manufacture and sell dietary supplements after it was found to be in violation of FDA manufacturing regulations regarding product potency and purity. Read more here. This example demonstrates that certification is just one snapshot in a moving picture. What happened yesterday may not consistently happen tomorrow.

CNCA Product Certification: To demonstrate to CNCA customers the differences in testing protocols associated with these various programs, CNCA voluntarily subjected its Milk Thistle PRO product to Consumerlab.com for testing. CNCA’s Milk Thistle PRO did more than pass Consumerlab.com testing; it was also reported as the most potent formula tested. Compare the testing performed by Consumerlab.com against the testing performed by CNCA below.

Ingredient Programs: USP and NSF offer “ingredient certification” programs. In 2008, Consumerlab.com had announced plans to do the same. This could be a step in the right direction if the testing profile is sufficiently comprehensive to consistently assure authenticity, potency and purity of the dietary ingredient. To achieve this, each ingredient program needs to be evaluated individually. Evaluating such programs is complex and requires expertise, time and inclination.

Other Programs: In various websites, and on various dietary supplement labels, several variations on this “certification” theme can be found (phrases such as “Laboratory Tested”, “GMP-Compliant”, “Independently Tested”, “USP Compliant”, etc.). But without mention of the specific tests performed, how much value do these certifications hold? In CNCA's view, not much.

On every CNCA product label, there is QUALITY PLEDGE. This quality pledge lists the tests performed consistently on that particular product and its ingredients. It is standard CNCA practice to provide doctors and consumers with factual, relevant information which support CNCA's superior quality claims.

Understanding Types of Regulatory Enforcement

At the federal level, dietary supplements are primarily regulated by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

Types of FDA Regulations: The regulation of dietary supplements began when the FDA defined “dietary supplements” at the request of Congress in passing the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). From that, FDA has created numerous laws that apply to the manufacture, packaging, storage and distribution of dietary supplements (Dietary Supplement Current Good Manufacturing Practices, or “cGMPs”).

As a result of DSHEA, there are also have extensive laws regarding product “labels” (which appear on the primary container of the dietary supplement), and product “labeling” (which accompany the sale of a dietary supplement in the form of an outer box, or accompanying literature).

FDA also has laws regarding “New Dietary Ingredients” which require FDA notification of intent to market before a “new dietary ingredient” can be introduced into the US market. If FDA is concerned about dietary ingredient safety, they can prohibit the introduction of that ingredient into the food supply.

Types of FTC Regulations: The FTC regulates advertising. For advertising to be lawful, FTC laws require that it must be “truthful and not misleading”. Infomercials – the 15 to 60 minute programs that sell products are subject to FTC regulation. Some of the most serious violations regarding the marketing of dietary supplements include infomercials for dietary supplements claimed to cure cancer. FTC judgments have been made and people have gone to prison for violating these important FTC regulations.

Enforcement Trends: Since it is illegal for a company to claim that a dietary supplement can treat, diagnose, cure or mitigate any disease (this is called “making a health claim”), the majority of FDA enforcement activity involves products that make unlawful health claims. To increase enforcement, the FDA has collaborated with the FTC¹². This collaboration is long-standing and on-going. It has been particularly effective in acting against internet marketers who sell dietary supplements as treatments for serious diseases.

The diseases of particular interest to FDA include cancer, diabetes, heart disease, and weight loss. For example, in August of 2006, FDA reports that a federal judge sentenced one John E. Curran to 12.5 years in prison for fraud and money laundering¹³. He was found guilty of posing as a “medical doctor” and selling false products that claimed to cure cancer.

The second area of enforcement involves adulterated and/or contaminated supplements. Examples include the 2006 recall of “men’s sexual health” dietary supplements because they contained the undeclared drugs sildenafil and vardenifil (more commonly known as Viagra and Levitra, which are respective trademarks of Pfizer and Schering Plough/GSK). One example of contaminated dietary supplement recalled from the market involves American ginseng (mentioned above) which contained the illegal pesticide, PCNB.

More about Label Claims: Label claims language is a controversial topic. The laws regarding dietary supplements label claims that are intended to protect consumers, also severly limit truthful statements that can be said about products. Consequently, consumers see labels that often say very little about what the product does or what it may be good for. For dietary supplements, “health claims” (i.e., claims that the product may diagnose, treat, prevent, or cure diseases) are illegal, while “structure/function” claims (i.e., claims that describe the effect of the product on the structure or function of the human body) are legal.

Consider the structure/function claim “Supports a Healthy Cardiovascular System”. In the case of omega-3 fatty acids from fish oil (the most important of which are EPA and DHA for cardiovascular “health”), there is enough compelling clinical data about the effects of EPA and DHA on the cardiovascular system. It is known that it can reduce triglycerides, increase HDL, and can modestly lower blood pressure.

But a dietary supplement company cannot legally claim its fish oil can “reduce triglycerides and increase HDL.” The regulators define that as an "implied health claim" because the consumers are aware that low HDL is a risk factor for a heart attack, and consumers understand that “reducing triglycerides or increasing HDL” helps to “prevent a heart attack”.

For prescription drugs, however, the claim “reduces triglycerides” has been approved by the FDA. There is a prescription drug on the market made from fish oil, which has been proven to be safe and effective in the treatment of certain types of high blood triglyceride levels. In comparing the prescription fish oil product against a dietary supplement, the drug is more than twice the cost of the supplement on a potency-adjusted basis. And this same drug has been approved in two other countries for “the prevention of second heart attacks!”

But for the fish oil dietary supplement, from a marketing and labeling standpoint, all that can be stated are phrases such as “supports a healthy cardiovascular system”. It will have the same effects on triglycerides and HDL levels as the prescription drug at half the cost, but supplement companies are simply prohibited from making those factual statements.

Making Sense of Vitamins and Supplements

This is a very complex issue. And there are no easy solutions. In the meantime, medical experts agree that protecting your long-term health is best served by maintaining proper weight, exercising regularly, getting sufficient rest and eating healthy foods.

But the USDA has been publishing data about the inadequacy of American diets for years¹⁴. And their data proves that the average American diet is deficient in several key nutrients. The USDA says:

Nearly 95 percent of people in the United States are not getting desirable intakes of vitamin E from foods and beverages. More than half aren't getting enough magnesium, about 40 percent aren't getting enough vitamin A, and nearly one-third aren't getting desirable intakes of vitamin C from the foods and beverages in their diets.

USDA, Agricultural Research Service, 9/29/2005

If this information from the USDA is accurate, then one could argue that regularly taking nutritional supplements should also be part of a healthy lifestyle.

CNCA: Expert Nutrition and Quality You Can Trust

A respected quality scientist once remarked, “Paper never refuses ink”. And this certainly applies to the certificate of analysis (COA) which accompanies shipments of dietary ingredients used in dietary supplements. As outlined here, fraud exists in the supplement industry.

Although years have passed since melamine was discovered in pet food and human food supplies, evidence of growing quality problems with dietary supplements, foods and drugs continue. Of 1,000 products tested, one in four dietary supplements were found to be subpotent, contaminated or both¹⁵. Of 230 aryurvedic products sold via the internet, one in five contained detectable amounts of lead, mercury or arsenic¹⁶.

The real challenge, for doctors and consumers alike, is choosing which supplement provider to trust. The doctors at Cancer Treatment Centers of America know that these problems exist. That’s why CNCA was created – to provide dietary supplements that physicians could consistently trust.

CNCA uses its best efforts to provide products that are authentic, potent and have maximum freedom from dangerous contaminants. CNCA consistently relies upon qualified third party analytical labs to validate all ingredients and verify finished products. CNCA orders magnitudes more testing than required by USP monographs because what’s NOT in the product is as important to CNCA as what is IN the product.

Doctors and hospitals trust CNCA dietary supplements. You can too.

References:

1. Pizzorno, J and Levin, M “FDA’s Natural Product cGMPs – A Missed Opportunity” Integrative Medicine, Vol 6, No. 5, Oct/Nov 2007.
2. www.consumerlab.com/news/Potassium_Supplements_Tests
3. www.fda.gov/cder/guidance/7654fnl.htm
4. www.fda.gov/cder/guidance/7654fnl.htm
5. The entangled web of international intrigue was reported in the New York Times: www.nytimes.com/2007/06/17/health/17poison.html?pagewanted=4&_r=2&emc=th&adxnnlx=1182071095-JUG5QkOWa1swk7owtQnDrQ;th;amp
6. www.fda.gov/CDER/GUIDANCE/Q3Cfinal.htm
7. www.fda.gov/fdac/features/2007/207_foodsafety.html
8. www.fsrio.nal.usda.gov/document_fsheet.php?product_id=48
9. Kren V and Walternova D “Silybin and silymarin – new effects and applications” Biomed. Papers 149(I), 29-42 (2005)
10. www.foodproductdesign.com/articles/0295qa.html
11. www.fda.gov/foi/warning_letters/s7030c.htm
12. www.fda.gov/oc/whitepapers/chbn_summary.html
13. www.fda.gov/fdac/features/2006/606_fraud.html
14. www.ars.usda.gov/is/pr/2005/050929.htm
15. /www.nutraingredients-usa.com/Research/Athlete-supplements-fail-to-meet-quality-standards
16. Heavy metal contamination common in Ayurvedic medicines. JAMA 2008; 300:915-23