2012 Aloe Summit
Inside Aloe: Turning Science into Sales
The 2012 Aloe Summit, produced by the International Aloe Science Council (IASC) in conjunction with Virgo Publishing, will provide aloe executives and businesses with the tools needed to turn the latest regulatory, research, and scientific findings into marketable claims and tangible sales and branding opportunities for products containing aloe vera in the food, beverage, dietary supplement, and cosmetic categories across all channels of distribution in the United States and abroad.
Hear from experts who will discuss aloe-related topics, including new methods of analysis, regulatory affairs, and compliance issues that will provide invaluable knowledge about distributing aloe products in a global market. Plus, network with key thought leaders in the aloe industry!
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8:30-9:30am - Continental Breakfast
8:40-8:45am - Introduction by Devon Powell, executive director, IASC
8:45-9:30am - Aloe Vera Leaf and Inner Leaf Juice: Quality and Compliance Standards
Presenter: Roy Upton, executive director, American Herbal Pharmacopoeia
Compendial standards for quality and compliance can go a long way toward assisting with assuring regulators of standardized components and ingredients. Hear from Roy Upton, executive director of the American Herbal Pharmacopeia (AHP) on the development process for producing a monograph, and the details included in the recently completed AHP monograph on aloe vera leaf juice and aloe vera inner leaf juice.
Aloe Vera: Identity Testing and Methods of Analysis
Presenters: Paula Brown, Ph.D., British Columbia Insitute of Technology; John Edwards, Process-NMR; Judy Nichols, CAMAG Scientific
An integral part of regulatory compliance, developing and using appropriate methods of analysis, is crucial. Hear from experts working in the field of analytical chemistry about the most up-to-date methods for the analysis of aloe vera, including the development process, validation work, and much more.
11:00am-12:00pm - Select Research on Aloe Vera
Presenters: Joseph Betz, Ph.D., Office of Dietary Supplements; Charlie Metcalfe, Custom Analytics
Hear from experts on the most current scientific efforts regarding aloe vera, including how to determine a method's suitability for verification of identity, and polysaccharide measurement of aloe vera via Gelpermeationchromatography (GPC).
12:00pm-1:00pm - Lunch
1:00-2:00pm - IASC Tonnage Survey and Related Market Data
Presenter: Devon Powell, IASC
This presentation will highlight findings from IASC's recent market survey, including data from global sources of raw materials, sales from the multilevel marketing, retail, and other channels in the food, beverage, and personal care categories. The survey includes findings from 2009-2010, and based on the data, projects the anticipated growth of the aloe vera market for 2012 and beyond.
2:00-2:30pm - Afternoon Break
2:30-3:45pm - Turning Science Into Sales
Presenters: Marc Ullman, Ullman Shapiro & Ullman LLP; Chris Noonan, Health Guidance; Steven Dentali, Ph.D., AHPA
This session provides an in-depth look at how to substantiate and turn scientific evidence into marketable claims to increase sales and build brands. It will include discussions about the regulatory framework for the sale of aloe vera products in several countries and regions, including the United States, Canada, Latin America, and the EU, and how they would be applied to claims and the marketing of aloe vera products as cosmetics/food/dietary supplements.
3:50-4:00pm - Closing Remarks by Devon Powell, IASC
Download printable version of the agenda: Click Here.
Click Here to Register!
Developed with: Virgo Publishing
FDA Issues Warning Letter to Vienna Beauty Products
On May 17, 2012, the Food and Drug Administration (FDA) issued a Warning Letter to Vienna Beauty Products of Dayton, Ohio, citing unsanitary conditions ("so dirty or ridden with germs as to be a danger to health") at the facility where the company produces its Triple Lanolin Aloe Vera Foot Scrub. Because the product is marketed "to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance," it is regulated as a drug under the Federal Food Drug and Cosmetic Act (FFDCA).
While cosmetics are arguably the most lightly regulated product category under the FFDCA, they are still regulated. Any product covered by the FFDCA is considered "adulterated" if it contains any ingredient that renders it unsafe, is produced under insanitary conditions, does not contain exactly what it purports to contain, or its labeling is false or misleading. In this case, FDA found that the company was manufacturing its products in a way that allowed for the growth of the microbial pathogens Pseudomonas aeruginosa and the Burkholderia multivorans/B. cepacia group in the Triple Lanolin Aloe Vera Foot Scrub, causing it to be adulterated and in violation of the FFDCA.
A review of the warning letter reveals several issues that any aloe company manufacturing cosmetics would be well advised to consider. These include:
Failure to check for microbial organisms in raw materials or finished product;
Construction within the facility that allows condensation to drip off of pipes and other fixtures onto equipment used to manufacture cosmetics;
Lack of any plan for testing the quality of water used in the manufacturing process;
Samples not taken, as appropriate, during and/or after processing, transfer, or filling to determine adherence to internal quality standards and absence of hazardous microorganisms or chemical contaminants;
Failure to adequately clean and sanitize production equipment and utensils; and
Failure to maintain control records for raw materials, finished product, product packaging, or quality control.
Each of these issues represents a fundamental failure of compliance with current good manufacturing practice (cGMP or GMP) that not only constitutes a violation of the FFDCA but also has the potential to create a threat to the public health. International Aloe Science Council (IASC) members producing cosmetic products would be well served to review their own practices to ensure that they are covering these and other GMP requirements. IASC members producing food or dietary supplement products should also take note, as the GMPs for their classes of goods are far more stringent than for cosmetics.
If you have questions about whether your company is complying with cGMPs or any other part of the law applicable to the class of goods you are selling, you would be well advised to consult with your counsel and a consultant with expertise in your area of production. It's far more cost effective to deal with GMP issues proactively and avoid FDA involvement.
If you have any questions please contact Devon Powell, IASC executive director, 301.588.2420 x102.