Differences between Dietary Supplement and Prescription Drug Omega-3 Fatty Acid Formulations: A Legislative and Regulatory Perspective

Collins, Nancy; Tighe, Ann P.; Brunton, Stephen; Kris‐Etherton, Penny M.

doi:10.1080/07315724.2008.10719743

Cited by 34 publications

(21 citation statements)

References 37 publications

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“…However, the contents of dietary supplements are not regulated by any agency at this time, and they can vary widely depending on the manufacturer and its standards. 23 Consequently, if the fish oil manufacturer, which was new to the field of dietary supplements, had been held to standards used in the pharmaceutical industry and had been rigorously overseen by a governmental regulatory agency, this minor outbreak of vitamin D toxicity might have been prevented. Nevertheless, a much greater outbreak was prevented because the manufacturer immediately recalled the products in the market upon our alert within a relatively short time.…”

Section: Discussionmentioning

confidence: 99%

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Vitamin D Intoxication Due to an Erroneously Manufactured Dietary Supplement in Seven Children

et al. 2014

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Pediatric cases of vitamin D intoxication (VDI) with dietary supplements have not been previously reported. We report on 7 children with VDI caused by consumption of a fish oil supplement containing an excessively high dose of vitamin D due to a manufacturing error. Seven children aged between 0.7 and 4.2 years were admitted with symptoms of hypercalcemia. Initial median (range) serum concentrations of calcium and 25-hydroxyvitamin D were 16.5 (13.4-18.8) mg/dL and 620 (340-962) ng/mL, respectively. Repeated questioning of the parents revealed use of a fish oil that was produced recently by a local manufacturer. Analysis of the fish oil by gas chromatography/mass spectrometry revealed that the vitamin D 3 content was ∼4000 times the labeled concentration. Estimated daily amounts of vitamin D 3 intake varied between 266 000 and 800 000 IU. Patients were successfully treated with intravenous hydration, furosemide, and pamidronate infusions. With treatment, serum calcium returned to the normal range within 3 days (range: 2-7 days). Serum 25-hydroxyvitamin D levels normalized within 2 to 3 months. Complications, including nephrocalcinosis, were not observed throughout the 1-year followup. In conclusion, errors in manufacturing of dietary supplements may be a cause of VDI in children. Physicians should be aware of this possibility in unexplained VDI cases and repeatedly question the families about dietary supplement use. To prevent the occurrence of such unintentional incidents, manufacturers must always monitor the levels of ingredients of their products and should be rigorously overseen by governmental regulatory agencies, as is done in the pharmaceutical industry. Pediatrics 2014;133:e240-e244 Vitamin D intoxication (VDI) is a rare condition today. Over the past 40 years, it has been usually described as a result of unintentional conditions, such as contamination of cooking oil, 1-3 overfortification of milk, 4,5 or adulteration of table sugar. 6 VDI associated with overthe-counter dietary supplements has been reported in adult patients. [7][8][9][10][11][12] However, to our knowledge, pediatric cases of VDI caused by dietary supplements have not been previously reported. We report here on 7 young children with VDI caused by the consumption of a fish oil supplement that contained an excessively high dose of vitamin D due to a manufacturing error. CASE HISTORIESA 2.5-year-old boy was admitted on September 24, 2011, with a history of fever, weakness, constipation, loss of appetite, nausea, and vomiting for 2 weeks. He was clinically dehydrated. His serum calcium and 25-hydroxyvitamin D (25[OH]D) levels were 13.4 mg/dL (normal range: 8.8-10.8 mg/dL) and 962 ng/mL (normal range: 30-80 ng/mL), respectively. His parents denied taking any drug or dietary supplement containing vitamin D.The second male infant, aged 13 months, was admitted 2 weeks later with a history of weakness, poor appetite, vomiting, weight loss, and constipation for 12 days. His physical examination was normal. His serum calcium and 25(OH)D l...

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Section: Discussionmentioning

confidence: 99%

“…23 Before a prescription drug is approved for a disease or condition, it undergoes rigorous review by the regulatory agencies. However, the contents of dietary supplements are not regulated by any agency at this time, and they can vary widely depending on the manufacturer and its standards.…”

Section: Discussionmentioning

confidence: 99%

Vitamin D Intoxication Due to an Erroneously Manufactured Dietary Supplement in Seven Children

et al. 2014

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“…In this respect it should be taken into account that only ω-3-acid ethyl esters 90 is manufactured with FDA and EMA regulatory approval and has an indication for the treatment of patients after myocardial infarction or patients with high triglycerides. Dietary supplements are available to consumers under the provisions of the Dietary Supplement Health and Education Act, for which the FDA has the burden of proving a dietary supplement is harmful rather than requiring the manufacturers prove that the supplement is safe [50]. One should be aware of the important qualitative and quantitative differences between an FDA- and EMA-approved formulations and dietary supplements [50].…”

Section: Discussionmentioning

confidence: 99%

“…Dietary supplements are available to consumers under the provisions of the Dietary Supplement Health and Education Act, for which the FDA has the burden of proving a dietary supplement is harmful rather than requiring the manufacturers prove that the supplement is safe [50]. One should be aware of the important qualitative and quantitative differences between an FDA- and EMA-approved formulations and dietary supplements [50]. In addition to oxidation products, one should also consider the number of capsules required, which affects the compliance particularly in patients who are already on multiple tablets.…”

Section: Discussionmentioning

confidence: 99%

Replacement of Reduced Highly Unsaturated Fatty Acids (HUFA Deficiency) in Dilative Heart Failure: Dosage of EPA/DHA and Variability of Adverse Peroxides and Aldehydes in Dietary Supplement Fish Oils

Rupp

Rupp²,

Alter³

et al. 2013

Cardiology

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Objectives: To explore the rationale for ω-3 fatty acids in heart failure treatment, the dosage of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) for replacing low levels of highly unsaturated fatty acids (HUFA deficiency) was examined. To judge the usefulness of various EPA/DHA preparations, their content of peroxides and aldehydes was determined. Methods: In 298 patients with dilative heart failure, the serum HUFA level was assessed by gas chromatography. In ω-3-acid ethyl esters 90 (Omacor/Lovaza, approved by the Food and Drug Administration and the European Medicines Agency) and 63 dietary supplement fish oils, oxidation products were determined by photometry. Results: Increasing serum HUFA from the lower (4.3 ± 1.0%) to the upper (9.5 ± 1.5%) tertile would be associated with an increased left ventricular (LV) ejection fraction (34.1 ± 9.9 vs. 28.3 ± 9.5%, p < 0.01) and reduced LV enddiastolic diameter (63.5 ± 7.1 vs. 66.9 ± 7.4 mm) requiring at least 2 g EPA/DHA daily. In fish oils, the peroxide and alkenal level varied greatly, i.e. peroxide value ≤5 mEq/kg in only 7 and ≤10 mEq/kg in 38 fish oils. Compared with equivalent doses of ω-3-acid ethyl esters 90, the mean peroxide intake would be 8.6 ± 6.1 and the alkenal intake 10.9 ± 4.4 times higher in fish oils. Conclusions: Levels of adverse oxidation products should be considered when targeting HUFA deficiency or treating patients with myocardial infarction or high triglycerides.

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“…In sector A on molecular nutrition, there are two special comments to be made. First, omega-3 fatty acids represent yet another example of a bioactive food that is both a nutrient and a drug (other examples being folate, niacin and vitamin A), and underscore the need to bring greater resolution to the 'nutrient-drug' debate [11,12]. In this regard, nutrigenetics/nutrigenomics has an important role to play in providing a molecular foundation for this dialogue.…”

Section: Anatomy Of a Partnership Model In Molecular Nutritionmentioning

confidence: 99%

Opportunities and Challenges in Nutrigenetics/Nutrigenomics: Building Industry-Academia Partnerships

Gillies

Kris-Etherton

2010

J Nutrigenet Nutrigenomics

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Differences between Dietary Supplement and Prescription Drug Omega-3 Fatty Acid Formulations: A Legislative and Regulatory Perspective

Cited by 34 publications

References 37 publications

Vitamin D Intoxication Due to an Erroneously Manufactured Dietary Supplement in Seven Children

Vitamin D Intoxication Due to an Erroneously Manufactured Dietary Supplement in Seven Children

Replacement of Reduced Highly Unsaturated Fatty Acids (HUFA Deficiency) in Dilative Heart Failure: Dosage of EPA/DHA and Variability of Adverse Peroxides and Aldehydes in Dietary Supplement Fish Oils

Opportunities and Challenges in Nutrigenetics/Nutrigenomics: Building Industry-Academia Partnerships

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