FAQ: How important is your baby? The value of PM Procare to you and your baby.

PM Procare is a comprehensive formula with all the nutritional supplements required to prepare a woman’s body for a healthy conception, as well as support her during her pregnancy and breastfeeding period. Ideally, it should be taken at least one year prior to conception through until one year after delivery.

The ingredients in PM Procare have been carefully researched and meticulously formulated at the amounts most suitable for this special period. The formula is designed to benefit not only mothers’ wellbeing, but also to cater for infants’ physical and intellectual development. We hope the rest of the family will also benefit from a healthy mother and baby.

The PM Procare formula includes all the essential vitamins and minerals such as folic acid, B-group vitamins and vitamin C. But one particularly key ingredient that accounts for the majority of each capsule is tuna oil (natural), with a high level of the omega-3 polyunsaturated fatty acid, docosahexaenoic acid (DHA), and with eicosapentaenoic acid (EPA).

The reasons for the additional cost of tuna oil will be answered while we are addressing other issues in this question, then recapped once all other questions have been answered.

Let’s go on to other issues now.

That can be answered by looking at the technical side, say, the human’s physiology and Tuna Oil’s pharmacology

That is mainly due to economic dynamics at play and how businesses do things in general.

It is true that fish oil is much cheaper than tuna oil in general. Specifically, the Tuna Oil we use in PM Procare is 6.5 times more expensive than the high quality fish oil material we normally use in other formulas that do not require tuna oil exclusively. It is much more expensive than fish oil comes from other sources with less quality control.

Because our Technical Department (R &D), after thorough research, has decided that tuna oil (natural) is the better ingredient for this particular formula (for mothers to be, breastfeeding mothers, and for foetal and infantile development). The underlying rationale for their decision is primarily due to the higher amount of DHA in tuna oil compared to fish oil, and the DHA to EPA ratio.  Most of us would be familiar with some or all of the benefits that may be derived from fish oils – particularly,  its Long-Chain Polyunsaturated Fatty Acids (LC-PUFAs) omega 3, DHA and EPA – as to cardiovascular health, digestive systems, eyes, the immune system, arthritis, mental health, the nervous system and skin health.

That is one of the reasons why fish oil in general has become very popular during recent years and in particular has led to a raw material price surge in late 2007. Demand has surpassed supply too much, leading to over-fishing and forcing governments to cut down fishing quotas, which in turn keeps the price rocketing. However, many people remain unaware of the scientific studies conducted on fish oils in recent years.

Physiologically, DHA is a critical component of cell membranes, especially in the brain and retina. Brain accumulation of DHA starts in utero (during pregnancy), with the majority in the second half of gestation. DHA accumulation in the brain continues after birth, reaching a total brain DHA deposition of about 4g between two and four years of age. In the retina, DHA comprises as much as 50% of total fatty acids of rod and cone outer segments. Unlike DHA, other omega-3 Long chain Polyunsaturated Fatty Acids (LC-PUFAs) do not accumulate to any appreciable extent in the growing brain and eye. DHA is converted from ALA (Alpha-linolenic acid) and EPA, but humans cannot synthesize these omega-3 families of the PUFA. As such, their parent fatty acids are termed as essential fatty acids, in that they are required by our bodies, but must be obtained from dietary sources. 

Again, we may all know that exceptionally rapid growth and development of the foetus occurs during pregnancy and for the young child during the first several years. In particular, brain growth accelerates during the second half of pregnancy and remains high during the first year of life. Relatively rapid growth continues for the next several years, and if supported will lead to developmental milestones in cognitive, visual, and motor development. 

It is therefore critical that both foetus’ and infants have the right food in adequate amounts to support their development.

During the earliest periods of development the foetus accumulates the essential DHA it needs through placental transfer and, following delivery, through breast milk. Both preterm and term infants can synthesize DHA and AA, however the conversion rates are influenced by genetics, gender, and the amount of precursor fatty acids available in the diet, with the best being mother’s breast milk.   Mothers therefore must ensure they have an adequate intake of LC-PUFAs to pass on to their infants, as well as a healthy level in their own bodies to satisfy their personal nutritional requirements.

The above is not just a theoretical deduction. Studies have shown a positive association between maternal dietary intakes of fatty fish and fish oils providing long-chain omega-3 fatty acids in pregnancy and/or lactation and visual and cognitive development along with other functional outcomes in infants.  The majority of studies showing beneficial health effects from the consumption of fish or fish oils during pregnancy and lactation have been conducted on DHA alone, while some have investigated both DHA and EPA.

Additional studies have also indicated that a high intake of DHA in mothers’ diets can be expected to cause a rise in DHA levels in their breast milk composition. Current average intakes of DHA during pregnancy and lactation in North America and many other countries are reported to be approximately 80 mg/day . Consequently, the mean level of DHA on North American breast milk is generally below 0.30-0.35% of total milk fat. In contrast, the breast milk of Japanese women approaches 1.0% of total milk fat and reflects daily intakes of DHA averaging 500-850 mg. Another 2006 study published with results obtained from breastfeeding women from 9 countries across the world again proves the relationship between elevated levels of breast milk DHA in countries with high dietary consumptions of fish .

The information on the above studies, and the fact that DHA accounts for such a high proportion and play such an important role in the brain and retina, has led to a search for food and supplement sources with high levels of DHA in recent years.

Of particular interest recently “Recommendations and Guidelines for Perinatal Practice” was issued in July 2008, a consensus recommendation for health-care providers supported by the World Association of Perinatal Medicine, the Early Nutrition Academy, and the Child Health Foundation. Dr Berthold Koletzko (M.D.) and 18 colleagues from 11 developed countries with expertise in the area of polyunsaturated fatty acids for human health and particularly infant and maternal nutrition and development, have co-authored a review on the Roles of Long-Chain Polyunsaturated Fatty Acids (LC- PUFA) in Pregnancy, Lactation and Infancy.

The recommendations are:

• The foetus and neonate should receive LC-PUFA in amounts sufficient to support optimal visual and cognitive development.
• The consumption of oils rich in n-3 LC-PUFA during pregnancy reduces the risk for early premature birth.
• In particular, pregnant and lactating women should aim to achieve an average daily intake of at least 200 mg DHA.
• For healthy term infants, breastfeeding is endorsed and supported, as this would supply preformed LC-PUFA.

Currently there are two  natural types of fish oil that are available commercially: Tuna oil and Fish oil. Tuna oil is processed from tuna species whereas fish oil is made from a combination of any other type of fish, depending on the manufacturers’ practice.

Tuna has the highest DHA to EPA ratio (4.33 : 1 or 26 DHA : 6 EPA) of any commercially fished species. Interestingly, the study on breastfeeding women’s milk composition in 9 countries  shows that tuna oil’s ratio of DHA : EPA resembles the ratio in human breast milk more closely than any of the other natural fatty acids available. The ratio in commercial fish oil, however, is 12 DHA :    18 EPA or (0.67 : 1). As such, in 1000mg of tuna oil, there is 260mg of DHA as compared to only 120mg in the same amount of normal fish oil.

Please note that this does not mean that EPA is not important, it is very important and we do use a combination of both EPA and DHA in our various formulas. However for this particular period, tuna oil is the best fit as it provides the highest level of DHA and a DHA : EPA ratio close to that of human milk.

Therefore, tuna oil is preferred over general fish oil for pregnancy and breastfeeding formulas.

Due to its benefit profile, its high level of DHA, and its DHA : EPA ratio, there is a high demand for tuna oil. On the other hand, as mentioned earlier, tuna oil is made from just the tuna species, whereas fish oil raw material is normally made from ANY combination of other fish species, depending on the particular grade of the fish oil. For eg, in our case, we only use fish oils that are derived from fish of the Clupeidae and the Eugraulide family (anchovies).  Even though this is a limited group of fish species, the additional number of fish varieties utilised makes it easier to harvest a set amount of fish oil as compared to harvesting exclusively from tuna. You can see that even in our case where we compare between high quality fish oil and Tuna oil, fish supply for Tuna oil is already much smaller than for fish oil, hence Tuna oil is relatively more expensive. Let alone other sources of fish oil that may utilize other types of fish in addition to/ beside Clupeidae and the Eugraulide family, in which the manufacturers have a lot more fish to catch or buy, leading to a higher supply and lower production costs. However, it is not possible to comment on other products without having their technical information or submitting their fish oil for analysis.

This, together with over-fishing and Governmental control of fishing quotas have driven the Tuna oil price upward to the point where it is significantly more expensive than fish oil. Further price differences between brands of fish and tuna oil may stem from variations in business practices, such as where manufacturers source their fish, purification, testing processes, quality and regulatory controls.

There are always differences between products in the market, even if they have similar formulas. The quality of tuna oil/fish oil products is at least partially determined by the countries in which they are manufactured, the facilities in which they are made and the regulations governing their synthesis.

There are undoubtedly some very cheap fish oil supplements available, and there are people who love hunting for a bargain. Yet unfortunately, for the most part, the old adage that “you get what you pay for” rings true. It is essential to understand what is contained within the products that you buy, where and how the raw materials are obtained and what types of quality control processes are in place for both raw materials and finished products.

Let’s talk first about the composition of fish oil/tuna oil on products’ labels as well as how this information is looked at in different markets.

In some cases, products are cheap because they don’t contain the same amounts of total omega-3, DHA or EPA as in PM Procare. In some such cases, this is simply because other products don’t use tuna oil (natural). In other cases, the price difference exists because testing is not done to ensure that the product contains the correct ingredients and the correct ingredient amounts listed on its label. In the latter, that may happen because countries have no regulations that require manufacturers to conduct thorough testing procedures as we are in Australia with PM Procare. 

Our products are regulated as therapeutic (medicinal) goods in Australia and have to comply with all of stringent regulations by the Australian Therapeutic Goods Administration (TGA), one of the strictest health authorities in the world. They have to meet with all the Good Manufacturing Process (GMP) requirements from the start to the finish of their production, before released to the market. Further, post-market surveillance requirements ensure that the products are monitored and controlled after they leave our warehouse by both regulator and us, the product owner.

On the other hand, similar products (for eg also as nutrition supplements) that are made in the USA are regarded as food supplements. While you cannot see what is inside the capsules or tablets for these products, you can see the differences on the labels. The labels of these American products focus heavily on “nutritional values” on a per dose serve, while all of our products declare what active ingredients they contain per capsule or tablet. According to the TGA’s regulations, we have to satisfy the authority that they will find each ingredient in the declared amount in each of our tablets or capsules. The health benefit claims on our products are also listed with the TGA, meaning that we are unable make beneficial health claims that we cannot back up with scientific evidence. Hence, no benefit we claim for any of our products can reasonably be labeled as “outlandish” or “outrageous,” or indeed anything other than “scientifically validated.” Maybe this example goes outside the focus of our discussion today, however we would like to present this as examples of the differences in the regulations in different countries, hence manufacturers and businesses are subject to different operation guidelines, which are partly responsible for the different costing and pricing.

The next issue nowadays with fish is contaminants.
On the one hand, health authorities advise us to eat more fish. On the other hand, they ask us to limit fish consumption due to its level of mercury and other contaminants, and also the environment risk of depleting the fish stock.

Contaminants are of course dangerous to anyone, however more so to pregnant and breastfeeding women as they may be detrimental to the baby’s development. Considerable research in this area has shown that children whose mothers consumed better quality (low level of contaminants) fish oil during pregnancy possessed better attention, learning, cognitive, memory and physical development. These skills were poorer in children whose mothers had relatively high mercury levels in their blood during pregnancy.
We are proud and confident with the raw material of, as well as the quality control in place for Tuna Oil used in PM Procare, from the raw material manufacturer to the finished product.

We maintain a very tight control over the source of materials we use, as well as the various processes they have to go through before going into the final products. In particular, we are absolutely confident with the Tuna oil we use. It is made by the American facility of Nu-mega, a subsidiary of an Australian publicly listed company named Clover Corp., who currently supply 50% of Mead Johnson USA’s needs for tuna oil and microencapsulated HiDHA power form .

Nu-mega does not use just any tuna. Rather, they harvest exclusively from selected species such as Albacore, Skipjack and Big Eye, fished from the pristine South Pacific waters, a clean source. Further quality processing helps to ensure that contaminants are held to strict specification.

Tuna oil is of course not cheap. As discussed earlier, our tuna oil costs 6.5 times more than the fish oil (120 DHA : 180 EPA) from similar quality sources, and is much more expensive compared to those from other origins. We have been approached by other suppliers offering much cheaper sources of fish oil. However after careful consideration and in some instances, inspection of the manufacturing facilities, we have decided it best to stick with what we are comfortable with – the highest quality tuna oil available. We are people with families of our own, and we believe that other people will appreciate our belief that everybody’s foremost task is to create a future generation that are healthy and better than ourselves both physically and mentally.

Even though we use a quality source, we do not just rely upon the information from our suppliers, we also have the raw materials tested independently before they are passed into the production line. Finished products are tested again to ensure that we are 100% happy with what we are releasing into the market.

As mentioned earlier, our PM Procare is not just a source of high grade, clean tuna oil. It includes essential minerals and vitamins including iron, calcium, potassium, magnesium, zinc, iodine, folic acid, betacarotene, and B-group vitamins (B1, B2, B3, B6, B12), vitamin C, witamin D3 and vitamin E. Many of these nutrients are hard to acquire even with a balanced diet. Folic acid is highly important as it reduces the risk of foetal neural tube defects such as spina bifida. The World Health Organisation recommends a minimum of 400mcg of folic acid for women daily, as this is considered sufficient to prevent most neural tube defects.       Also included are iron and iodine, essential for foetal neural and brain development, while calcium, magnesium and vitamin D3 are important for bone development and ongoing cell health. Potassium, zinc, betacarotene and vitamin E are also similarly important for cell patency, while B group and C vitamins are essential for foetal cell production, metabolism, and energy utilisation.

Please note that our vitamins and minerals have been sourced from the quality manufacturers including European based-Roche and Cognis. These manufacturers are GMP-accredited, ensuring quality pharmaceutical grade raw ingredients.

We cannot comment about what is in other people’s products; it is best if consumers check what is inside, or where the various components of the products are made from, how they are made and whether or not they are quality controlled. As for our products, we are happy at any time to provide all the information and for anyone to conduct an independent test on any aspect of the product. Indeed, we relish to opportunity to stand up to any scientific enquiry about PM Procare.

As for the consumers out there, I would like to urge that you check the products you are going to take, balancing the costs against the benefits and risks, for your own sake and for that of the most important person in your life. Your child.