Pharmaceutical Grade Fish Oil
Benefits Heart & Arthritis --
How to Find the Best
Not all pharmaceutical grade fish oil is the same quality. To optimize the health benefits from omega 3 fatty acids, it’s important to find the best fish oil supplement available.
Whether for heart or inflammatory arthritis improvement, the following five tips will help you make an informed choice (our recommendation is covered after Tip #5):
- Pharmaceutical grade
- EPA/DHA amount per serving size
- Triple molecular distillation
- Guarantee of purity in writing
- Record of clinical studies by the manufacturer
Tip #1. The product should be “pharmaceutical grade”
Look for pharmaceutical grade fish oil on the label.
Generally, pharmaceutical grade omega 3 is higher in quality and purity than non pharmaceutical grade fish oil supplements. The dictionary defines pharmaceutical grade as “of a standard suitable for use as a medicine.”
As a dietary supplement, “pharmaceutical grade fish oil” is the newest marketing generation for fish oil products. There are no governmental regulations in place for the dietary supplement industry to define the term’s use by the U.S. Food and Drug Administration (FDA).
Dietary supplements are considered as foods, not as drugs and have no rigid enforcement [the FDA’s current Good Manufacturing Practices (cGMP) for the industry do not require standardized purity testing nor proof of product efficacy].
A definition by the Medical College of Georgia describes “pharmaceutical grade” as a term referring to a standard or level of purity suitable for the production of medicine within the pharmaceutical community. The product must be in excess of 99% purity with no binders, filters, dyes, or unknown substances. To achieve this level, a product must:
- be produced in a fully compliant, government approved facility,
- offer full document traceability detailing every step of the supply chain process for each batch of product produced,
- exceed product purity levels, and
- meet consistent, tight specifications for each batch of product produced. To be fully considered “pharmaceutical grade”, a product should also have an active “Drug Master File” recognized by multiple governmental health or drug agencies.
So how can you determine if a fish oil is really pharmaceutical grade? Some manufacturers claim their product is pharmaceutical grade because it is manufactured in an FDA certified facility. Others base the claim on the purity of the oil. Because there’s no industry standard, in most cases you have to take their word for it.
Tip #2. Determine the EPA/DHA amount per serving size
Look for the EPA/DHA amount on the pharmaceutical grade fish oil label.
There are two main long-chain dietary omega-3 fatty acids – EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) found in fish and fish oil supplements.
Pharmaceutical grade fish oil supplements should contain approximately 1 gram (900 to 1100 mg) total EPA/DHA per serving size daily. Most fish oil supplements contain 2 or 3 or 4 capsules or softgels to comprise a daily serving size.
A minimum recommended concentration of omega 3 fatty acids in a 1 gram daily serving size is as follows:
- EPA 545 mg
- DHA 360 mg
- Five other naturally found fatty acids including ALA 95 mg
The concentrations of EPA and DHA in fish oil supplements currently sold vary by as much as ten fold—from just 8% to 79% per capsule according to industry watchdog, ConsumerLab. Concentration depends on the source of the omega 3s, how the oil is processed, and the amounts of other ingredients included in the supplement.
The health benefits of EPA and DHA are the best known of the seven omega-3 fatty acids. The best source of EPA and DHA is fish oil. Over 4,500 research studies on omega 3s effects on overall health have been conducted in the last 25 years.
A daily serving of most fish oil supplements contain 1 gram or less of omega 3s, according to ConsumerLab.
The U.S. Food and Drug Administration classifies intake of up to 3 grams per day of omega-3 fatty acids from fish as GRAS (Generally Regarded as Safe).
The best fish oil supplements will contain a full spectrum of seven naturally occurring omega 3 fatty acids, including EPA. DHA, alpha-linolenic (ALA), docosapentaenoic, stearidonic, eicosatetraenoic and heneicosapentaenoic acids.
Tip #3. Triple molecular distillation
Look for triple molecular distillation on the pharmaceutical grade fish oil label.
Processing of the pharmaceutical grade fish oil supplement is perhaps its ultimate test. The best fish oil brands are pharmaceutical grade (stated on the label) and have been purified to remove contaminants.
Molecularly distilled fish oils are considered to be the purest and safest, because this process removes nearly all of the unhealthy contaminants and toxins from the fish oil.
One manufacturer advertised that it produces the world’s finest pharmaceutical grade fish oil because their processing method features a proprietary, triple molecular distillation process that concentrates natural beneficial omega 3 fatty acids. The process helps remove impurities and contaminants such as lead, mercury, arsenic, cadmium, dioxins, and PCBs.
Tip #4. Guarantee of purity in writing
Make sure the pharmaceutical grade fish oil supplement manufacturer provides a written guarantee of purity.
Most companies honor a money back guarantee, but purity is the underlying concern with all fish oil supplements, even those who claim to be “pharmaceutical grade”.
In addition to a money-back guarantee, does the manufacturer put into writing a 100% guarantee that the ingredients listed on the label are in the product; a 100% guarantee of quality-controlled product formulations that ensure product safety, purity, reliability, and product performance; and a 100% guarantee that they use the finest quality ingredients available?
Click here for an example of the guarantee of purity by the triple molecular distillation company referenced above.
Loose regulation by the FDA of the dietary supplement industry contributes to the possibility of substandard products on the market.
On March 2, 2010, the world’s largest producer of fish oil products was sued under California Proposition 65 for not revealing to consumers that their supplements contained toxic levels of PCBs.
The defendants in this lawsuit were the world-leading Omega Protein, a Houston-based company, and the many companies that they produced fish oil for – companies like Rite Aid, CVS, GNC, Now Health Group, Pharmavite, Solgar and Twinlab.
The plaintiffs (The Mateel Environmental Group) alleged it only tested 10 omega-3 supplements manufactured by Omega Protein to date and found PCBs in all of them, ranging from 12 nanograms a day to more than 852 nanograms a day, based on the daily recommended dose written on the labels. Mateel plans to continue testing and to add other companies to the lawsuit if their products are also contaminated. The allegations in the lawsuit have not yet been proven in court.
Consumer Reports conducted its own study of a 15 fish oil brands, published in its January 2012 issue.
Entitled, Fish Oil Pills versus Claims, their testing revealed discrepancies in quality of 5 (33%) of those tested.
According to the article, "Americans are buying more fish-oil supplements than ever, but in industry-standard tests of 15 top-selling brands conducted by an outside lab for Consumer Reports, five fell a bit short."
Tip #5. Clinical studies by the manufacturer
This is the clincher--clinical studies. What evidence does the pharmaceutical grade fish oil manufacturer provide that it participates in clinical studies on its product(s)? Ask them. Call or email the manufacturer and ask them.
Clinical studies are not required by dietary supplement manufacturers. Few companies go to the expense to do so because they aren’t required to.
One manufacturer, Shaklee Corporation, has repeatedly done so voluntarily with over 100 scientific papers authored and 90 published in peer-reviewed journals. They walk the walk to prove the effectiveness of their own products. They’ve invested over $250 million in exhaustive product research and development, and clinical trials, according to their website.
Founded in 1956, this omega 3 fatty acids fish oil manufacturer is a recognized leader in the natural nutrition industry.
Recommended pharmaceutical grade fish oil
One pharmaceutical grade fish oil supplement, Omega Guard, scored at the top on each of the five tips.
As mentioned, this supplement features a proprietary, triple molecular distillation process that:
- Temperature and duration controlled processing protects integrity of the finest quality fish oils.
- Minimizes thermal heat degradation.
- Low temperature distillation process helps remove saturated fats, yielding pure, highly concentrated essential omega-3. Contaminants often found in fish and fish oils are removed, including lead, mercury, arsenic, cadmium, dioxins and PCBs.
This process produces a healthier fish oil by suppressing formation of dangerous trans fats. It’s ultra pure and free of saturated fat and cholesterol.
The product also provides a full spectrum of all seven naturally found omega-3 fatty acids.
Derived from whole, fresh fish this fish oil meets the utmost standards for quality and purity, according to the manufacturer. It is certified by Friend of the Sea, an international conservation organization, under strict criteria for sustainability, including full traceability in every phase of the process.
One daily serving size of 4 softgels provides over 2400 mg of natural fish oil, including 726 mg of EPA, 480 mg DHA plus 130 mg of five other naturally found fatty acids (docosapentaenoic, stearidonic, eicosatetraenoic, heneicosapentaenoic, and alpha-linolenic acids).
It is bioavailable, that is, fully absorbed and available at the desired site in the body after consumption. It also boasts low odor, has no aftertaste, is easy to digest and is gluten free.
Based on the evidence presented on this page, we sincerely believe it is the very best fish oil supplement. We consider it the finest fish oil supplement found on the market anywhere. Note: Label directions read: "Take 2 softgels one or two times daily with meals." We use the 180-count size, which is a 90-day supply using two a day, or 45-days at four daily. For our arthritis, we prefer four or more daily. It's also available in a 60-count size.
A side note: my husband and I have personal testimonies on the use of fish oil supplements and other natural products for the control of pain, inflammation, swelling and stiffness for our arthritis conditions. We endorse Omega Guard from personal use.
*Pharmaceutical Grade Fish Oil disclaimer: Health statements on this pharmaceutical grade fish oil page have not been evaluated by the Food and Drug Administration. These products p>.
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