Safety of EMPowerplus™ in Pregnancy and Breastfeeding

EMPowerplus Advanced is very safe to take during pregnancy and breastfeeding. In fact, there have been over 500 women who have taken the EMPowerplus during pregnancy, post-pregnancy and while breastfeeding.

Mothers report that their children who were born while they were taking EMPowerplus Advanced during pregnancy and breastfeeding are much healthier, stronger, sleep for longer periods, are superior in school and have better cognitive function than their children born pre-EMPowerplus.

The EMPowerplus Advanced formula has also helped many women who experienced postpartum issues such as anxiety and depression. Pregnant women require more nutrients as they are supporting the growth of the baby. Taking EMPowerplus while pregnant is preventative for a variety of health concerns as well as post-partum issues for both mom and baby.

Due to some concerns below is a more in-depth study of certain ingredients that can be of concern.

Study of Vitamin A, D, E, Germanium, and Phenylalanine

In light of recurring questions regarding the safety of consuming vitamin A, D, E, Germanium, and Phenylalanine (ingredients in EMPowerplus™) during preconception, pregnancy, and lactation we have compiled a brief review of regulatory and academic literature.

Vitamin A

The Food and Nutrition Board, Institute of Medicine has set the recommended daily allowance (RDA) for vitamin A intake for women aged 19-70 years at 700µg (2333 IU). Recommendations for pregnancy (aged 19-50 years) only increase by ten percent to 770µg (2566 IU). The Institute of Medicine, however, also makes a provision for a tolerable upper limit for pregnancy in the same age range. This amount is a 428.6% increase from the RDA to 3000µg (10 000 IU).

“The tolerable upper intake level (UL) is the highest level of daily vitamin A intake that is likely to pose no risk of adverse health effects in almost all individuals.” This tolerable upper limit was established at one fifth (20 percent) of the lowest observed adverse event level (LOAEL) of 14 000µg (46 000 IU). (source 1)

In a press release dated July 22, 1997, the National Institute of Child Health and Human Development, a division of the NATIONAL INSTITUTES OF HEALTH, reported on a vitamin A study conducted by the Institute. The study found that taking daily doses of between 8,000 and 10,000 IU of vitamin A during pregnancy does not appear to cause birth defects contrary to what many researchers had feared. Fears of teratogenicity (causing birth defects) began after rates of birth defect began rising in groups of women taking Isotretinoin (Accutane) a vitamin A analog. Because 13-cis-retinoic acid or its metabolites, is teratogenic at high concentrations (those present during therapy with Isotretinoin), the authors still recommend caution for high doses of all forms of vitamin A.

Even so, the authors concluded “This study found no association between periconceptional vitamin A exposure at doses >8000 IU or >10,000 IU per day and malformations in general, cranial neural crest defects, or neural tube defects. If vitamin A is a teratogen, the minimum teratogenic dose appears to be well above the level consumed by most women during organogenesis.” (source 2)

The quantity of vitamin A contained in the loading dose (15 capsules) of EMPowerplus™ would be 5760 IU.

Vitamin D

The Food and Nutrition Board, Institute of Medicine has set the recommended daily allowance (RDA) for vitamin D intake for women aged 19-50 years at 5.0µg (200 IU). Recommendations for pregnancy (aged 19-50 years) remain the same. The Institute of Medicine, however, makes a provision for a tolerable upper limit for pregnancy in the same age range. This amount is a 1000% increase from the RDA to 50µg (2000 IU). “The tolerable upper intake level (UL) is the highest level of daily vitamin D intake that is likely to pose no risk of adverse health effects in almost all individuals.”

This tolerable upper limit was established at 83.3 % of the no observed adverse event level (NOAEL) of 60µg (2400 IU). (source 3)

The quantity of vitamin D contained in the loading dose (15 capsules) of EMPowerplus™ would be 1440 IU.

Vitamin E

The Food and Nutrition Board, Institute of Medicine has set the recommended daily allowance (RDA) for vitamin E intake for women aged 19-50 years at 15 mg. Recommendations for pregnancy remain the same while those for lactation increase to 19 mg. The Institute of Medicine, however, makes a provision for a tolerable upper limit for pregnancy in the same age range. This amount is a 6666.7% increase from the RDA to 1000 mg. “The tolerable upper intake level (UL) is the highest level of daily vitamin E intake that is likely to pose no risk of adverse health effects in almost all individuals.”

This tolerable upper limit was established at one thirty-sixth (1/36) of the lowest observed adverse event level (LOAEL) of 500 mg/kg/day (based on an average male and female body mass of 68.5 kg or 151 lbs). (source 4)

The quantity of vitamin E contained in the loading dose (15 capsules) of EMPowerplus™ would be 80.4 mg.

Germanium Sesquioxide

The questions about germanium revolve around its chemical form. The literature shows that the inorganic (no carbon-germanium bond) forms of germanium can be toxic, especially at high doses (such as germanium dioxide, and germanium lactate citrate). The literature also shows quite unmistakably that organic carboxyethyl germanium sesquioxide (Ge-132) is quite safe, even at high doses.

This understanding of the role of Organic Germanium (Ge-132) originates from Dr. Asai’s primary finding that Organic Germanium (Ge-132) occurs in high concentrations in medicinal plants (source 5) (such as ginseng, garlic, aloe, and comfrey) (source 6). It appears that organic germanium, as Dr. Asai has identified, is one of the key active components responsible for the therapeutic action of many natural remedies.

While the literature on Germanium indicates that the organic forms are not toxic, Okuda and colleagues (1987) (source 7) cast doubt on that conclusion. They reported on the toxicity of germanium compounds in four patients. In two cases the patients were believed to be taking Ge-132, although the supplements were not analyzed. One year later, Matsusaka and colleagues (1988) (source 8) published two additional cases of germanium-induced nephropathy. In this paper they provided the renal biopsy data for their own patients as well as the data for the four patients published the previous year by Okuda.

The tissue biopsy revealed that Okuda’s patients were, in fact, taking contaminated Ge-132; in particular, the two patients believed to have taken Ge-132 were definitely found to have taken GeO2. However, the Okuda paper has been mistakenly cited numerous times in the literature as evidence of the nephrotoxicity of Ge-132. Two years later Sanai and colleagues (1990) (source 9) (the second author on the Sanai paper is the same Dr. Okuda whose 1987 paper did not differentiate the chemical forms of Ge) presented both human data and animal data demonstrating, 1) the toxicity of high doses of GeO2 (150 mg/kg/day for 10 weeks) and 2) the lack of toxicity of high chronic doses of Ge-132 (240 mg/kg/day for 10 weeks). Okuda (1987) published in all probability not knowing, at the time, that the Ge-132 was contaminated with GeO2. This comparatively small error has had an amazingly large impact on later publications. For example, the following authors read and accepted the conclusion of Okuda et al., and did not read the article by Matsusaka (Matsusaka et al., 1988), or Okuda’s own followup article in 1990 (Sanai et al., 1990):

  1. (Krapf et al., 1992. (source 10)
  2. Schauss, 1991a. (source 11)
  3. Schauss, 1991b. (source 12)
  4. Takeuchi et al., 1992. (source 13)
  5. Tao & Bolger, 1997. (source 14)

The articles by Schauss and by Tao and Bolger, because they purport to be summary and review articles, and are so often cited by other sources signify the most striking perpetuation. The Tao and Bolger article, an FDA review, is specifically disappointing in that they reference both the Okuda (1987) and the Sanai papers but continued to cite Okuda (1987) as having confirmed the toxicity of Ge-132.

The quantity of Germanium Sesquioxide contained in the loading dose (15 capsules) of EMPowerplus™ would be 20.7 mg.

Phenylalanine

The Food and Nutrition Board, Institute of Medicine has set no recommended daily allowance (RDA) for phenylalanine, and there is insufficient adverse effect data to establish a tolerable upper limit. Based on distribution data it was determined that the average daily intake for all life stages and gender groups from food and supplements is 3.4 g/day. Most of the literature on the consumption of high doses of phenylalanine comes from studies on the effects of large doses of the artificial sweetener aspartame, which is 50 percent phenylalanine by weight. Adults given oral doses from 4 to 200 mg/kg body weight (2 to 100 mg/kg body weight phenylalanine) showed only dose-related increases in plasma phenylalanine (source 15) (upper oral doses around 7 g).

Phenylalanine, considered indispensable, is very important to the function of the Central Nervous System. It is the most direct precursor to the amino acid tyrosine, which is, in turn, a precursor to the neurotransmitters norepinephrine and dopamine. Without tyrosine, the production of these very important transmitters would cease. In humans, about 16 percent of ingested phenylalanine is converted to tyrosine.

The quantity of phenylalanine contained in the loading dose (15 capsules) of EMPowerplus™ would be less than 400 mg.

Special Considerations

Phenylalanine should be avoided by the small number of people–about 1 in 16,000–who have the hereditary disease phenylketonuria (PKU). This is a genetic disorder, from birth, that impairs phenylalanine hydroxylase (PAH) activity which results in higher than normal levels of the amino acid or its catabolic byproducts to accumulate in the plasma during critical periods of brain development. If dietary phenylalanine is not restricted within one month of birth and continued at least through childhood and adolescence irreversible brain damage can result. PKU is now screened for at birth and with dietary restrictions infants can live a normal lifespan. Pregnant women with PKU should maintain strict dietary control before conception and throughout pregnancy (See footnote 15 previous page).

Conclusion

The human organism, not to mention all life on earth, has had interaction with these kinds of elements since the beginning of its existence. We have hundreds of years of experience with these compounds as compared to manmade compounds. The dangers from excess have been well documented and the levels of these particular nutrients in EMPowerplus are safe to consume especially during preconception, pregnancy, and lactation when the requirement for certain nutrients can increase significantly. (source 16 & 17)

 

Sources:

  1. Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes: Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. National Academy Press, Washington, D.C., 2001.
  2. http://www.nih.gov/news/pr/jul97/nichd-22.htm
  3. Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. National Academy Press, Washington, D.C., 1997.
  4. Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. National Academy Press, Washington, D.C., 2001.
  5. Asai, R., 1980. Miracle Cure: Organic Germanium, New York: Japan Publications/Kodansha International via Harper and Row.
  6. Jao, S.-W., Lee, W., & Ho, Y.-S. (1990). Effect of germanium on 1, 2-dimethylhydrazine-induced intestinal cancer in rats. Diseases of the Colon and Rectum, 33, 99-104.
  7. Okuda, S., Kiyama, S., Oh, Y., Shimamatsu, K., Oochi, N., Kobayashi, K., Nanishi, F., Fujimi, S., Onoyama, K., & Fujishima, M. (1987). Persistent renal dysfunction induced by chronic intake of germanium-containing compounds. Current Therapeutic Research, 41, 265-275.
  8. Matsusaka, T., Fujii, M., Nakano, T., Terai, T., Kurata, A., Imaizumi, M., & Abe, H. (1988). Germanium-induced nephropathy: report of two cases and review of the literature. Clinical Nephrology, 30(6 – 1988), 341-345.
  9. Sanai, T., Okuda, S., Onoyama, K., Oochi, N., Oh, Y., Kobayashi, K., Shimamatsu, K., Fujimi, S., & Fujishima, M. (1990). Germanium dioxide-induced nephropathy: A new type of renal disease. Nephron, 54, 53-60.
  10. Krapf, R., Schaffner, T., & Iten, P. X. (1992). Abuse of germanium associated with fatal lactic acidosis. Nephron, 62, 351-356.
  11. Schauss, A., G. (1991a). Nephrotoxicity and neurotoxicity in humans from organogermanium compounds and germanium dioxide. Biological Trace Element Research, 29(3), 267-280.
  12. Schauss, A. G. (1991b). Nephrotoxicity in humans by the ultratrace element germanium. Renal Failure, 13(1), 1-4.
  13. Takeuchi, A., Yoshizawa, N., Oshima, S., Kubota, T., Oshikawa, Y., Akashi, Y., Oda, T., Niwa, H., Imazeki, N., Seno, A., & Fuse, Y. (1992). Nephrotoxicity of germanium compounds: Report of a case and review of the literature. Nephron, 60, 436-442.
  14. Tao, S. H., & Bolger, P. M. (1997). Hazard assessment of germanium supplements. Regulatory Toxicology and Pharmacology, 25(3), 211-219.
  15. Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Part 2). National Academy Press, Washington, D.C., 2002.
  16. Favier M, Faure P. (1994). Supplements during pregnancy: fad or necessity? Rev Fr Gynecol Obstet. Apr;89(4):210-5.
  17. Black RE. (2001). Micronutrients in pregnancy.Br J Nutr. May;85 Suppl 2:S193-7.