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Description
BioCeuticals is an Australian provider of nutritional and therapeutic dietary supplements range produced for practitioner use only.

Dietary supplementation has proven to be a popular consumer development, as well as a beneficial business venture. In today’s Australian market, vitamin and dietary supplementation generated an estimated revenue level of up to $2.33 billion dollars in 2015. Dietary supplementation and vitamins aid micronutrient deficiencies for the average person.

History
BioCeuticals is owned by Blackmores Limited and was acquired on July 2nd 2012 for $40 million. Despite company relations, BioCeuticals has committed to continue to be a practitioner-only range due to higher dose formula developments, not legal for direct public access without a medical prescription.

BioCeuticals operates as a stand-alone business, separate to Blackmores Limited. The range has remained an independent business venture, delivering accredited health practitioners with higher dosage, integrative medicines and supplements. In order to stock or deliver products to patients, you must be considered a qualified healthcare professional under Section 42AA of the Therapeuticics Good Regulations 1990 and/or a member of a recognised association as per schedule one of the regulations listed.

Research Participation
BioCeuticals takes part in the following research studies and clinical trials:

1.UltraClean EPA/DHA Plus & CardioNutrients undertaken in the Alfred Hospital’s MPM orthopaedic recovery trial, and Integrative Cardiac Wellness Program.

This is an interactive Cardiac Wellness Program run by clinical professionals.The aim of this project is delivery of alternate complementary medicines, therapies and supplements to aid cardiac health. It is for patients diagnosed and suffering from heart disease. BioCeuticals supplies fish oil UltraClean EPA/DHA Plus, CoEnzyme Q10, Magnesium Orotate and Vitamin D supplements to this project.

2.Patent-pending D3 liquid emulsion in paediatric vitamin D supplementation trial and Perthes disease trial at The Children’s Hospital at Westmead, NSW

This is professionally run medical research conducted by Dr Craig Munn's, a paediatric endocrinologist at the Westmead Children's hospital. The Paediatrics Medicines Advisory Group have highlighted vitamin D deficiencies in children, resulting in bone and growth development problems. The aim of these clinical trials is to determine if periodic, supra-physiologic doses of vitamin D (STOSS Therapy; 100,000IU/week for 4 weeks) is necessarily better than long-term, lower doses of vitamin D (e.g. 5000IU daily for 80 days) to treat vitamin D deficiency in children and adolescents. BioCeuticals provides vitamin D supplements these clinical trials.

3.Fish oil, obesity, cardiovascular disease risk study conducted by Princess Alexandra Hospital & The University of Queensland used UltraClean EPA/DHA Plus

This is a clinical trial conducted by Princess Alexandra Hospital with the aid of The University of Queensland to investigate the impact of the fish-derived omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on cardiovascular disease (CVD) and type 2 diabetes incidence. The study also aims to derive strategies to provide better affordable food sources high in omega-3 fatty acids in order to reduce the need for supplementation. BioCeuticals provides fish oil supplements for comparison purposes in this study.

Alliances
BioCeuticals have the following partnerships:

Medicines Australia

Medicines Australia represents The Australian Medicines Industry and recently has engaged up to a billion dollars of scientific research.

International Probiotics Association

International Probiotics Association is a global representative association for Australian probiotic manufacturing and supplementation.

Global Organisation of EPA and DHA Omega-s

BioCeuticals supplies fish oil products according to the international guidelines set by the Global Organisation of EPA and DHA Omega-s. This is an independent third Government body issued to monitor contamination levels from heavy metals, oxidation residues and other contaminants.

Australian Register of Naturopaths and Herbalists

BioCeuticals are in accordance with the goals of the Australian Register of Naturopaths and Herbalists (ARONAH).

Australian Integrative Medicine Association (AIMA)

The Australasian Integrative Medicine Association (AIMA) is the peak body representing integrative medicine (IM) doctors and practitioners in Australasia.

Australasian College of Nutritional and Environmental Medicine (ACNEM)

The Australasian College of Nutritional and Environmental Medicine (ACNEM) is a non-profit medical college established in 1982, offering postgraduate training and education for doctors and other graduate healthcare professionals.

Policies
BioCeuticals adhere to the following Government policies:

Cash Back Promotion – Entitles customers to full refunds if they do not receive or are not satisfied with their purchased product.

Retail Policy – This is a signed, government recognized policy ensuring appropriate pricing and sale structures are in place. This includes for independent third-party health practitioners and allied health professionals who deem themselves legible to sell BioCeutical supplements.

Online Selling Policy - This incorporates online sales from varying companies and businesses, as well as larger pharmaceutical branches and operations. This independent body also monitors advertising and consumer breaches during the marketing process of these supplements and medicines.

Formal Notification of Policy Breach –This is an independent third party organization monitoring consumer complaints and inappropriate product handling or manufacture procedures

Clinical Supply and Sales Policy – This independent third party ensures quality assurance and promotion for product misuse by health practitioners and third party distributors.

Code of Conduct Breaches
July-August 2013 – No. 1099, FIT BioCeuticals, Website Breach of Sections 13.3 and 13.8, Monitoring Committee, Pay a $25 000 fine.

The BioCeuticals website contained promotional claims that could be accessed by the general public. A third party independent monitoring committee also noted that FIT-BioCeuticals product D50K had not been registered in Australia as a dietary, therapeutic supplement or alternative medicine. Furthermore, the advisory body derived that claims made on the website were inappropriate, emphasising that claims were made suggesting the product was made available to the general public when it was not registered and supposed to only be available via healthcare professionals. The conclusion was derived that FIT-BioCeuticals were in breach of section 13.3 – Promotion to the general public, and Section 13.8 – Use of the internet

Evidence to back this claim showed that FIT-BioCeuticals promoted an injectable Vitamin D supplement not yet approved by the TGA. Therefore due to the higher dose of Vitamin D contained in the D50K product, this meant the product was not a listable product, but a registrable product, concluding a breach of conduct.

Medicines Australia Code of Conduct governed that the product requires a prescription from a healthcare professional. A response was subsequently submitted by review and resolution by another independent third party, the Paediatric Medicines Advisory Group.

The TGA submitted for a fine of $150 000 to be delegated to BioCeuticals as well as direction to immediately correct the website

BioCeuticals appealed that the committee had not proved sufficient evidence, nor an explanation, indicating weaknesses in the committee’s decision making process. Consequently, Bioceuticals sanctioned an appeal by another independent body, Committee Chairman and the Code of Conduct Medicines Australia Appeals Committee. This came to the conclusion of a $20 000 fine, as well as agreement to a compliance audit to be appropriately documented with evidence regarding general promotional practices made by BioCeuticals, which is to be regulated monthly.

Quality Assurance
BioCeuticals have the following in place:

BioCeuticals have a scientific advisory committee, as well as a product development department team in place in order to work and develop formulates.

The company also has compliance procedures established to promote product safety and consumer confidence. For example, FIT-BioCeuticals have anonymous consumer taste testing.

BioCeuticals also have running, present, current and planned clinical trials. This ensures for consistent evidence and scientific research being closely monitored and compared to contemporary scientific formulae and medical research.

Employment
Employs 114 people

Supplies 2118 pharmacies

Full year sales approx. $40mil (2018)

Product Complaints
Consumer Complaints

1.Products mislabelled, dishonesty

A consumer complaint regarding the product, Bioceuticals Intestamine 2018 Review. The product was misleadingly labelled as vegan however it was proven to contain glucosamine from sea crustaceans.

2.Pill sizes

A consumer complaint regarding the product, Bioceuticals InNatal 2018 Review. The size of the pill was determined to be 8mm diameter by 20mm long and perceived by many consumers to be a choking hazard.

Consumer Promotion

3.Convenient and easy to use

A consumer reviewed the product Vitamin B12 Spray 2016 Review. The product was reviewed to be an easy spray under the tongue, highly effective and a non-intrusive method of intake. In addition, this product was reviewed by consumers to be especially beneficial for vegans.