Posted by: Audrey Erbes | February 22, 2015

Are Supplement Regulations Strong Enough? Plus Events and Jobs

Do Dietary Supplements Utilize Appropriate Standards of Manufacture and Purity?

Regulations for medical products are necessary to ensure we are receiving the product for which we paid while also providing the level of   effectiveness and the dose on the label. With the new dietary recommendations recently published, I hope that supplement standards will keep up. I’ve beginning to worry about whether the supplements I’m taking her worth it.

After the accusation by New York State Attorney General Eric Schneiderman that major retailers were selling fraudulent herbal supplements, consumers nationwide are questioning whether they can continue to accept claims of these major retailers without question. There is rightfully concern whether or not these supplements are pure or meet the labelling promise of contents and the associated question of under what manufacturing conditions they were packaged. It has always surprised me that supplements, so similar to other over-the-counter products don’t have similar good manufacturing requirements with inspections. They can’t complain that they don’t have enough income to pay for meeting higher standards with over $16 billion in sales in the U.S. each year.

When I learned that 90% of vitamin C sold in the U.S. is supplied by Chinese companies a few years ago, I began to ask the outlets where I purchased my vitamins the source of their products. Only Trader Joes would insure me that their products’ contents were not sourced from China. I worried about the potential for heavy metals being included in those products or melamine as experienced in consumer products like toothpaste and dog food manufactured with ingredients from China. I was pleased that in the past couple of years the FDA began to require that manufacturing of these supplements not be adulterated but there is actually no apparent testing or inspections to ensure that.

Now that these supplements are known to possibly interfere with prescription meds or medical observation of a patient, it’s even more important that their purity be assured.

Author Frank L. Jaksch Jr.’s article “Dietary Supplement s Need Higher Standards” published in the San Jose Mercury News, Feb. 19, 2015 suggests that  “Consumers should demand higher standards and the industry should deliver. To ensure high quality products and to ensure that the FDA’s current Good Manufacturing Practices (cGMP) are met, audits and inspections should be performed. Laboratory testing of ingredients and finished products should be implemented to confirm that they meet minimum testing requirements. The reality is that if a finished consumer product, even a well-tested one, was manufactured in a facility that is not FDA cGMP compliant, the product is adulterated.”

Highlights of Coming Week’s Bay Area Meetings

  • Bio2Device Group, Tuesday Morning, Feb. 24, 2015, Topic: “The Forth Modality,” Speaker: Dr. Roger Vertrees, CEO, Verthermia
  • BayBio Lunch and Learn, Tuesday Midday, Feb. 24, 2015, Event: Lunch and Learn: Review of the Sunshine Act | Lessons Learned
  • FDA, Tuesday Morning, Feb. 24, 2015, Webinar: “Overview of Medical Device Data Systems, General Wellness Devices, and Medical Device Accessories”
  • Rosenman Institute D-Series, Tuesday Evening, Feb. 24, 2015, Topic: “Loma Vista Medical: Lessons About Pivoting And The Hidden Dangers Of Product Launches”
  • Clinovo, Wednesday Evening, Feb. 25, 2015, Topic: “Paper Trials vs. EDC Solutions: Benefits, Challenges, and Best Practices,” Panelists: Esmeralda Sanjust Elixir Medical Sr. Director of Clinical Affairs; Ana Pulido Ferrer Digitaliza TXT, Chief Executive Officer and Victor Chen Align, Technology Director Clinical Affairs; Moderated by: Marc Desgrousilliers, Clinovo Chief Technology Officer
  • BioScience Forum, Wednesday Evening, Feb. 25, 2015, Topic: “Manipulation of the Immune Response to Cancer with Biologics,” Speaker: Gary Starling, Ph.D., Associate Vice President, Biologics Discovery Operations, Merck Research Laboratories, Palo Alto
  • BayBio, Wednesday Mid Day, Feb. 25, 2015, Event: “Lunch & Learn | Clinical Trial Transparency: How New Trends And Regulatory Changes Will Impact Your Company,” Speaker: Scott Cunningham, Partner at Covington & Burling LLP
  • WIB San Francisco Bay Area, Thursday Evening, Feb. 26,2015, Event: “Finding – and Getting – Your Worth: Negotiating Compensation,” Panelists: Dorian Hirth (Senior VP of Human Resources at Nektar), Mary Haak-Frendscho (Chairman of the Board at Compugen), plus others

Important Conference Coming to the San Francisco Bay Area Next Week

CalBio 2015, March 2-3, 2015 is a statewide business and development conference jointly sponsored by BayBio and Biocom held in Bay Area every two years. Theme: “CalBio 2015: Turning Challenges into Opportunities,” Location: San Francisco Marriott Marquis, 780 Mission Street (at 4th Street). San Francisco, California 94103. Life Science companies and their management from around the state will congregate in San Francisco. Learn more at www.CalBio2015.org

To discuss how CEOs and entrepreneurs perceive and manage risk within the turbulent life science industry, CALBIO2015 offers a platform for industry leaders in California to share ideas ranging from science to business to global issues.

The CALBIO2015 Conference provides an opportunity for a frank and thoughtful discussion on how to turn today’s challenges into tomorrow’s opportunities. The two-day statewide industry event attracts the world’s leading life science and pharmaceutical companies, investment funds, patient foundations and university technology transfer offices.

Registered attendees will receive access to a partnering/meeting online tool that will allow them to perform quick and advanced searches of registered companies and individual conference attendees to best identify potential business partners. This provides invaluable face-to-face meeting opportunities. See details at https://www.calbio2015.org/business-partnering/

See the detailed agenda at https://www.calbio2015.org/agenda/

You can download Audreys Picks Feb. 22, 2015 with complete details on the above and other meetings and conferences through May 2015 by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough Feb. 22, 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

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