The problem of quality assurance in the natural product industry is huge. The industry is inundated with poor quality products and outright fraud. As a physician, this creates a tremendous challenge to assess which products and which companies are safe and effective for our patients.
There are estimated 1,200-1,500 natural product manufacturers in the U.S. now constituting at least a $25 billion dollar industry. The majority do very little quality assurance testing. Many raw materials for dietary supplements come from China and India where quality problems are notorious. It is not uncommon in this industry to have contaminants such as heavy metals and drug contamination. Not all raw materials from these countries are contaminated and the quality problem is certainly not limited to those countries. These same problems have occurred in Germany, Spain, Mexico and here in the U.S.
So one would think in this industry the FDA or some organization would be monitoring our safety. Unfortunately this is not true.
The FDA was required in 1994 to establish Good Manufacturing Practices (GMP) for supplements. It took until 2007 before they finally issued complete regulations on GMP’s. The GMP’s are milestones for the industry but unfortunately it is very unlikely that the FDA will be able to enforce them or that the manufacturers will voluntarily follow the regulations. Some companies will try to mislead the public about being certified by writing on the product GMP compliant. This does not mean the company has met the certification.
However, certification from the Therapeutic Goods Administration of Australia assures that medicinal products meet the same standards required by the Australian Pharmaceutical industry. Very few U.S. supplement manufacturers that I know of have achieved this TGA certification. Metagenics and some other physician Lines are compliant and hence it is only these types of companies I choose to use in my pharmacy.
As you can see this lack of quality control makes it very critical as a physician that I know what companies are meeting the highest of standards so that when I prescribe a supplement or botanical product, I know I will get the effect I need to treat the disease. Equally as important, I must know I will not harm the patient with contaminants. A classic example is when I need to use fish oils to assist against depression or heart disease. For these diagnoses I may have to prescribe higher doses of fish oils. If they are not quality controlled then the patient may get exposed to a large mercury level that was in the fish.
So for my practice it was critical to create a holistic pharmacy where I know, the nutrients and botanical remedies are of the purest quality, and they are created at the researched dose. This ensures that the therapeutic affect is achieved for the patient. It is not uncommon that a patient might tell me they got a product on line or at the health food store such as niacin or red rice yeast to lower their cholesterol. Then on recheck of their labs they did not improve. Unfortunately then they conclude the natural alternative did not work. Many times it is because the dose or quality of the product was too low or too poor.
I want patients to realize that dis-ease is 90% of the time due to deficiencies, toxicities and poor lifestyle choices. Food is always your first best medicine. I have found by using food extracts, botanicals and high grade supplements I can commonly assist the body that is in a disease state back to health. My last choice as a physician is to use pharmaceutical options because these usually will not correct the disease state but mainly help manage it.
So I hope to extend this service of a holistic pharmacy to the Fort Collins community and to continue to educate them. As you can see, due to the lack of regulations in this industry not all supplements, medicinal and neutraceuticals are of the same quality or effectiveness. The Healing Gardens Store is open to the public. This holistic pharmacy ensures that the data being published in the integrative medicine journals is then translated to the right formula and at the correct therapeutic doses. We also guarantee high quality physician researched products with companies we can trust. Come Visit us on our website at www.thehealinggardens.org or come and see us at 315 Canyon Ave. Fort Collins, or contact us at 940-472-6802.
By Jacqueline Fields, MD
I currently run a nutritional, medicinal store called The Healing Gardens Medicinal Store in Fort Collins. This was created to provide my patients and the community with high quality supplements using companies that assure product safety. Unlike Europe, our supplemental industry is not regulated. Unfortunately, this means that quality assurance is not always provided to customers. It is disturbing that many supplemental companies claim that their products are safe and made with quality ingredients while independent lab studies have proved these claims to be false.
Currently, even contaminants such as metals are in some over the counter supplements. A good way to protect yourself is to learn about professional companies that do provide outside lab quality assurance. You can check out how your products rate at consumerlab.com, an independent police force for product quality.
Like supplements, many cosmetic products contain unsafe ingredients. In my research, I was alarmed to learn that the majority of cosmetic products, such as, moisturizers, shampoos, makeup, etc. contain extremely toxic ingredients. An estimated 100,000 synthetic chemicals are currently registered for use in the United States. Fewer than 10% of these chemicals have been tested for their affects on human health. Unfortunately, a significant number of these chemicals have found their way into our personal care products and our environment. Because of this disturbing news, I decided to create a safe and effective cosmetic line. I want the phrase, “Safe Cosmetics” to be part of my community’s general health knowledge.
In order to educate my patients, I provide them with a list of known carcinogens that are commonly found in everyday products. Two classes of synthetic chemicals known as parabens and phthalates are among the worst offenders.
Unfortunately, the FDA does not regulate the use of these chemicals, nor does it require manufactures to disclose them as ingredients. The “Trade Secret” loophole allows manufactures to conceal these potentially deadly chemicals as “fragrance”.
Thankfully, large organizations such as the Breast Cancer Fund and the Endocrine Disruption Exchange, have become aware of the dangers of these chemicals and are beginning to educate the public. Jeanne Rizzo, RN and executive director of the Breast Cancer Fund stated, “It is unacceptable that the cosmetic companies continue to use ingredients that are breast carcinogens as well as other toxic chemicals in their products. We call on the cosmetic industry to phase out their use of these harmful ingredients.”
Theo Colborn, PhD and president of the Endocrine Disruption Exchange in Paonia, Colorado says, “There is no doubt about the need for extreme caution in using products that contain parabens and phthalates. Well over 100 studies since 1992 have demonstrated that these chemicals can disrupt both male and female hormone function, interfering with the roles of estrogen and testosterone in animal and tissue cultures. Other studies have found intact parabens in human breast tumors. Colborn also states that a broad spectrum of birth defects and lifelong reproductive impairments occurred in lab animals exposed to phthalates.
June Hamilton, vice president of research for the Environmental Working Group (EWG) in Washington, DC states that a typical US woman applies about twelve products every day. On average, that is a staggering 168 potentially harmful ingredients. Ms. Hamilton confirms that the risk from multiple exposures increases the detrimental affects.
After learning this staggering data, I rapidly started working with a natural pharmacist to create an all natural line of skin care called, Dr. Fields’ Sacred Skin. With this line, I took the best scientific data and combined it with plant medicine. I made a commitment to eliminate synthetic chemicals, parabens, phthalates, propylene glycol, EDTA, urea, artificial colors, fragrances, and all other known toxic agents. I am also committed to using only herbal infusions, essential oils, and plants. Of course, I have rejected the use of petroleum in my products because petroleum can clog pores and, more importantly, it is a nonrenewable resource.
The body absorbs 60-70% of whatever is applied topically to the skin. Sometimes, this is even more than gut absorption. It is essential for our health and the health of our environment not to bombard our bodies with these chemicals. This is no different than what I teach people about food. These days, there are many chemical preservatives in food, which are extremely unhealthy.
for our bodies. Our bodies also absorb harmful chemicals through our skin. I hold this motto: “If you can’t eat what you put on your skin, it’s probably not safe.” In addition, I registered my skin care line with the Campaign for Safe Cosmetics. This organization asked hundreds of cosmetic companies to sign their Compact for the global production of safe health and beauty products. This includes a pledge that their products will meet all standards and be free of chemicals known or strongly suspected of causing cancer, mutations, or birth defects.
The European Union has taken the international lead in guarding the public against chemicals in personal and household products. In 2001, the EU classified phthalates as substances that are toxic to reproduction. Many US manufactures oppose tighter regulations, but with increased awareness and pressure from advocacy groups, results are slowly beginning to be seen. Fortunately, 175 companies have signed on with Safe Cosmetics, but we have a long way to go in educating the public and changing legislation.
Although changes are starting to happen, do not be fooled by companies who call their products “natural” after adding a few herbs or drops of oil. Many times, these “natural” products are filled with other harmful ingredients. Much still needs to be done before cosmetic labeling becomes meaningful.
For more information:
The Healing Gardens Medicinal Store
The Breast Cancer Fund
Think Before You Pink
The Campaign For Safe Cosmetics
The Environmental Working Group