Medicine vs. supplements

About InVita D3 - Medicine vs. supplement

Despite the ability to get vitamin D from food and the sun, an estimated 40-75% of people are vitamin D deficient.1
With budget restrictions being placed upon the NHS, a number of healthcare professionals have chosen to advise patients to purchase their own vitamin D supplements or adapt their lifestyle to increase intake but this is rarely adhered to, for various reasons. Some patients believe they will receive a prescription if it is important, some patients are not able to afford to purchase themselves.2

But what are the differences between lifestyle inclusion, medicines and supplements?

Sunshine, not food, is where most of our vitamin D comes from3 but many factors affect the skin’s ability to produce vitamin D including1 cloud cover, age, clothing, sunscreen and the time of day.

Food does provide some of our vitamin D intake however, to reach the recommended levels a large volume of certain foods must be consumed on a frequent basis and is found to be generally unachievable. Examples of food consumption4 that are equal to 800 IU of vitamin D include:

(800 IU is a recommended daily dose for the average adult)

What is a medicine?

A medicinal product is: any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or any substance or combination of substances that may be used by or administered to human5 beings with a view to:

  • Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
  • Making a medical diagnosis

Medicines are manufactured to Good Manufacturing Practice
(GMP) standards at premises inspected by local regulatory authorities. GMP is that part of quality assurance that ensures medicines are consistently produced and controlled to the quality standards appropriate to their intended use and as required by their marketing authorisation.6 Without GMP it is impossible to be sure that every unit of a medicine is of the same quality medicines are manufactured within tightly-defined product specification requirements.

Supplements are:4

“foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form”7

  • Food supplements are not intended to prevent or treat any disease7 and are not required to be registered or authorised for sale in the UK8
  • Medicines can be distinguished from food supplements by their marketing authorisation5

Examples of food supplements prescribed in England include Pro D3, Hux D3 and Valupak

Food supplements may not meet the standards of assured quality required by medicines:

Vitamin D-containing food supplements have shown large variation in their colecalciferol content (between 8% and 201% of the labelled amount).9 The colecalciferol content of food supplements and compounded vitamin D preparations may be extremely variable (between 9% and 146% of stated dose).7 Not only can there be variation between different food supplements, but there may also be variation among different pills from the same bottle.10

For InVita D3 (colecalciferol) 25,000 IU oral solution, the colecalciferol content must be between 95-105% of the stated value.11

References:
  1. https://www.webmd.com/diet/features/are-you-getting-enough-vitamin-d#1
  2. BDA The Association of UK Dietitians Food Fact Sheet – Vitamin D. 2013.
  3. Data on file. Consilient Health Ltd.
  4. https://www.health.com/health/gallery/0,,20504538,00.html#getting-more-vitamin-d-0
  5. Human Medicines Regulations 2012 (SI 2012/1916).
  6. http://www.mhra.gov.uk/Howweregulate Accessed August 2018.
  7. MHRA Guidance Note No. 8. A Guide To What Is A Medicinal Product. Revised November 2012.
  8. Department of Health. Food supplements Guidance notes on legislation implementing Directive 2002/46/EC on food supplements. Updated January 2012.
  9. Garg S et al. Evaluation of vitamin D medicines and dietary supplements and the physicochemical analysis of selected formulations. Journal of nutrition,health & aging. 2013; 17(2): 158-161.
  10. LeBlanc ES et al. Over-the-Counter and Compounded Vitamin D: Is Potency What We Expect? JAMA Intern Med. 2013; 173(7): 585-586.
  11. Consilient Health Ltd. Data on File DOF001. July 2014.