October 23, 2013

Drug vs Cosmetic: Does the FDA Regulate all the products you think they do?

Do you ever wonder if your skin cream or make-up is safe? Most of us assume that if we are buying a cosmetic product at our local drugstore or mall, that the ingredients have been approved and tested by the FDA.
According to Dr. Stanley Tocker, an expert in chemicals used in cosmetics for The CECON Group, with the exception of color additives, only products that are labeled as food or drugs are regulated by the FDA.  If a product is NOT an approved drug, its ingredients have not been tested, reviewed, or approved by a government agency.

So, your cosmetics can contain any ingredient the manufacturer selects as active or inert components. It is certainly in the legal interest of the manufacturer and marketer of a product to do sufficient product safety testing.

What steps should consumers take to research the products they use? Obviously read labels and reviews of products (one summary of possible toxins can be found here). Check the FDA’s page for product recalls (click here to see a warning about mercury poisoning linked to certain skin products).

Dr. Tocker recommends checking the safety of suspicious ingredients online. Some chemicals to avoid include parabens, glycolic acid, some sunscreen agents (see EWG website), and strong detergents/exfoliants. Consumers should also test a small amount of any new cosmetic on an obscure body part (such as an arm) prior to applying to the more sensitive skin on the face.

Generalized safety guidelines are difficult because each person reacts differently. Judging safety in some ingredients is a matter of quantity used, individual sensitivities, care taken in use, and frequency of use. Some chemicals react with other products used by the consumer to cause a reaction not anticipated by reading label ingredients.

For more information, see the FDA’s Cosmetics Page.

October 7, 2013

Adult Stem Cell Therapy Status: Summary and FDA Issues

Embryonic stem cells are often discussed in the media, but adult stem cell technology gets less coverage.  The article below is a primer on adult stem cell technology and therapy, with comments on a recent FDA ruling. Attorneys, pharma consultants and investors may be interested in the potential impact of adult stem cell technology and applications for future cases and opportunities.
Adult stem cells exist in all people and are naturally used by our bodies to repair and regenerate injured issue.  The generation and use of naturally occurring stem cells generally diminishes with age.   Adult stem cells differ from embryonic stem cells in that they are based on embryo or placenta materials, which have a much larger ability to adapt to specific body tissue and organs. There are many types of adult stem cells, but mesenchymal stem cells are considered the most useful.  Mesenchymal stem cells (MSC) can be harvested from tissue in the body rich in MSC, such as bone marrow or adipose tissue.

Typically in adult stem cell therapy, stem cells are harvested from the bone marrow, often from a patient’s hip, by aspiration.  They are then concentrated by centrifugation and mixed with blood platelets extracted from the patient’s blood; blood platelets are rich in natural growth factors and aid in the stem cell’s effectiveness.  The concentrated stem cells and blood platelets are combined and then precisely injected back into the damaged part of the body in need of regeneration.  Such procedures are usually done the in one day at an outpatient clinic with little discomfort to the patient.

The claims of positive results from adult stem cell therapy are huge, in areas such as:  Repairing meniscus tears in the knee; repairing shoulder joint injuries; healing diabetic wounds; regenerating back tissue; regenerating heart tissue and valves; and reducing back pain.  There are also experimental reports of in vitro organ growth using adult stem cells, where a “constructed” organ is placed in the body to carry on normal functions.  The literature is replete with examples of marvelous outcomes with adult stem cells therapies that, while not nearly effective as embryonic stem cells therapies, sidestep the ethical and supply issues associated with embryonic cells. 

Adult stem cell therapy has FDA problems, however. For extensive coverage, click here.  In July of 2012, litigation involving Regenerative Sciences, LLC  as the defendant and the FDA, the United States District Court for the District of Columbia ruled in favor of the FDA.  The ruling essentially said the “Regenexx” procedure is a drug under the Federal Food, Drug, and Cosmetic Act and must comply with New Drug Application (NDA) regulations for current Good Manufacturing Practices (cGMP).  This issue has not been resolved, but Regenerative Science continues to practice the procedure on the “surgery exemptions “ of  CFR 21 Part 1271.15(b).  One basis of Regenerative’ s position is that “…patient’s cells are harvested in the morning, isolated and processed, then re-injected into the patient’s injured area – all within a period of a few hours.”  More elaborate adult stem cell procedures are practiced outside the United States to avoid FDA issues.  Many doctors believe the FDA is inhibiting successful client therapies and the science and medical breakthroughs of adult cell technology.  Some medical specialists imagine that medical device manufactures, such as those supplying spine, knee and hip replacement parts, lobby against adult stem therapy, seeing it as a disruptive technology.

 It is important to note that Dr. Shinya Yamanaka, a Japanese physician and researcher, won the Nobel Prize in Physiology (Medicine) in 2012 (along with Dr. John Gurdon) for the discovery that certain cells can be converted to cells closely resembling embryonic stem cells.  Recently, the Spanish National Cancer Research Centre (CNIO) reported that it has successfully treated adult stem cells in such a way as “…to recover the characteristics of embryonic stem cells.”  The research in stem cell medicine and science that circumvents the embryonic approach is intense. 

Finally, there is the equipment side of adult stem technology, whose growth is important to consider. One equipment leader is Harvest Technology Corp. located in Massachusetts but operating globally and owned the Japanese company Terumo  that specializes in blood management system and cardiac and vascular therapeutics.  Harvest provides point-of-care equipment for marrow aspiration, centrifuges to separate adult stem cells, and growth factors and disposables that are used in clinics.

Medical researchers and scientists, medical device specialists, and investors should keep a close eye on the progress, successes and acceptance, particularly by the FDA, of future adult stem cell technology and applications.

Additional information on this topic can be found in the videos below:
http://www.youtube.com/watch?v=OkS8ShmW7GQ or http://www.youtube.com/watch?v=L_8tmSw3UU8 ) 

What do you think the next innovation will be using stem cell technology?

The author, Boyd Sorenson, is a Vice President with The CECON Group, Inc. He holds a B.S. in Chemistry, and an  MBA, from Brigham Young University. Boyd is a technical marketing and business expert and executive with over 40 years' experience in defining, launching and operating high-technology new business. Boyd worked 25 years for the Du Pont Company, followed by 5 years at W. L. Gore, 4 years importing titanium dioxide from China for North America markets, and 9 years as the President of The CECON Group, Inc.