RAPS Annual Conference & Exhibition, October 24-27, San Jose, CA

I will be at the RAPS annual conference next week, and look forward to hearing more about the latest developments in the regulatory world and establishing professional contacts.  I will try to post interesting topics and discussions at the conference. 

Caffeine and Alcohol, conventional mix or beverage from hell?

Last November, the FDA notified nearly 30 manufacturers of alcoholic beverages containing added caffeine that it intends to look into the safety and legality of their products.  The FDA requested that each manufacturer provide its rationale, and supporting data and information, for concluding that its use of caffeine in an alcoholic beverage is GRAS (generally recognized as safe) or prior sanctioned, within 30 days of the notice.

The Pittsburgh Post-Gazette published a follow-up report on the FDA's inquiry today.  Nearly a year later, 19 of the 27 companies have responded, including some who asked for more time.  Apparently, the FDA is still evaluating this issue "as quickly as possible" but "a decision regarding the use of caffeine in alcoholic beverages could take some time."

An ingredient added to food (other than dietary supplements) is a food additive, which requires pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition.  However, a substance is exempt from the definition of a food additive (and exempt from pre-market approval) if it is GRAS. 

For a particular use of a substance to be GRAS, there must be both (1) evidence of safety, and (2) a basis to conclude that this evidence is generally known and accepted by qualified experts. 

Doctors and state attorney generals have presented their "anti-GRAS" studies showing that those who use caffeinated alcohol beverages drink more often, binge drink more often and are more likely to engage in risky behavior such as driving with a drunk driver.

It would be interesting to see the outcome of this case as well as the basis of these manufactures' GRAS determination, if any.  Rum and Coke, anyone?

The Fed took action against unapproved "drug" manufacturer

The federal government has barred a Montana company from the manufacture and sale of unapproved new drugs and dietary supplements, the FDA announced this week.  The order came in the form of a consent decree, filed in U.S. District Court for the District of Montana Wednesday and subject to court approval.

According to the FDA, the company manufactured and distributed a variety of unapproved new drugs that "were ineffective in treating the diseases they claim to treat."

The products - sold under such names as Black Salve, Cancema and Can-Support -- included topical salves purported to treat skin cancer, and oils and capsules to combat "serious diseases such as breast cancer, asthma, anemia and epilepsy," according to the FDA.

The FDA characterized many of these products as dietary supplements.
"The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers," Autor said. "The FDA is committed to ensuring that consumers do not become victims of false cures."

In signing the consent decree, the company agreed to stop making and selling unapproved new drugs and products with unauthorized health claims and to hire an independent expert to review claims made for any future products, according to the statement.

Had the company hired an independent expert to review claims made for their products before they put them on the market, I suspect they would not have ended up in such deep trouble.

Knee device should not have been cleared, says FDA

In a press release released by the FDA today, the agency announced that an orthopedic device used in the knee should not have been cleared for marketing in the United States.

According to the FDA, a scientific re-evaluation of the device was conducted because records from the original review was not adequate to "dispel questions about the role of outside pressures on the review process."

The timing of this press release is interesting because the FDA is currently re-evaluating its medical device clearance process to see if it needs to be improved to ensure the safety and effectiveness of medical devices marketed in the U.S.  Proponents of the change have argued that the current review process is not transparent enough and is susceptible to outside influences.  The finding by the FDA about the orthopedic device appears to support that assertion.

First clinical trial with human embryonic stem cell began

Geron announced yesterday that it has began the first clinical trial of human embryonic stem cells.  The primary objective of this Phase I study is to assess the safety and tolerability of the stem cells.  However, instead of using healthy objects like in a typical Phase I trial, this study is conducted with patients who have suffered from what's called a complete thoracic spinal cord injury.

According to CNN, the FDA first approved the trial in January 2009, but later required further research before the study could proceed.  The FDA gave final approval in July of this year.

Stem cells are cells that have the ability to divide and develop into many different cell types in the body during early life and growth.  When a stem cell divides, each new cell has the potential either to remain a stem cell or to become another type of cell with a more specialized function, such as a nerve cell, a skin cell, or a red blood cell.

Information about the trial is thin on the FDA's website, as expected.  However, the FDA did publish this PowerPoint presentation, which shed some light on the safety issues the agency was focusing on.  Among them is the ability to predict inappropriate differentiation / tumorigenicity of the injected cells. 

As discussed stem cells can differentiate into different type of cells, including cancer cells.  Because we still don't know how the body regulates this differentiation process, it is not surprising that the FDA is particularly interested in how Geron would track the injected cells and monitor the differentiation process.

FDA stepped up enforcement, issued more warnings to the industry and consumers

If you've been following the FDA's enforcement actions lately, you may notice that the agency has been very busy dealing with recalls, warning letters, and new rules that would require tighter regulatory oversight of products.

For example, according to LA Times, warning letters for misleading labeling and other violations issued by the FDA's Center for Drug Evaluation and Research jumped from 24 in 2005 and 21 in 2006, to 103 in 2009.  Additional warning letters also come from FDA regional offices and from other agency offices responsible for the safety and effectiveness of food, biologics, medical devices, cosmetics and other products.

That new activity hasn't gone unnoticed in political circles.  David Acheson, the FDA's top food safety official during the George W. Bush administration, contends that the agency is overzealous in pursuing allegedly bogus health claims made by food producers.  However, he had to admit that "on balance, it's been mainly science."

I have advised many of my clients (especially small and medium sized businesses) that, no matter how "right" you think you are to do or say something (or how "wrong" you think the FDA is), you would have to stop doing or saying it once the FDA asked you to stop, unless you have the resources to fight it.  In light of the FDA's stepped-up regulatory activities, it is especially important to seek experienced FDA counsel in the early stage of product development to minimize your risks.

FDA revised selenium health claims, but would you want to use them?

Alliance for Natural Health US, a trade group who sued the FDA after the agency denied their health claim petition, announced last week that it has reached a partial settlement with the FDA regarding the case.

According to Natural Products Insider, the following claims may now be used on labels and in labeling of selenium-containing dietary supplements in the U.S. effective immediately:

• "Selenium may reduce the risk of prostate cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of prostate cancer."
• "Selenium may reduce the risk of colon cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of colon cancer."
• "Selenium may reduce the risk of bladder, colon, prostate, and thyroid cancers. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers."

Previously, one the claims read: "Two weak studies suggest that selenium intake may reduce the risk of prostate cancer.  However, four stronger studies and three weak studies showed no reduction in risk.  Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer."

The trade group asserted that the FDA's previous claim is at odds with the Supreme Court's mandate that there be a "reasonable fit" between the government's goal (of protecting public health and preventing consumer fraud) and the restrictions it imposes on commercial speech.  Specifically, the agency re-wrote the trade group's proposed claim, instead of inserting an appropriate disclaimer after it.  The new claims appeared to remedy that issue.

Although the new claims are shorter and can get the point across more directly, one has to wonder who would put the statement "FDA concludes that it is highly unlikely that" the claim is true on their products.

FTC has no business regulating speech from the heart, says POM Wonderful

Last week, the Federal Trade Commission (FTC) charged POM Wonderful, the maker of a brand of pomegranate juice, with making unsubstantiated health claims about its products.

The federal agency said the juice and supplements firm made "false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction."  The complaint says the company "violated federal law by making deceptive disease prevention and treatment claims" with ads in the New York Times and other publications and on the Internet.

In an editorial published by the LA Times, Michael Hiltzik takes a closer look at POM's reactions to the charge, as well as the scientific research, which was funded by the company, behind the health claims.

It is not surprising that the people at POM are outraged by the charge and content that the federal government is infringing on their right of free speech.

The most interesting part of the editorial is perhaps POM's assertion that the company owner's (Lynda Resnick) statements about the product should not be taken as an "advertisement" and that since they were made in an interview, they are none of the FTC's business.

According to POM, Resnick is "talking about what she personally believes with respect to the science that she's seen. ... Lynda's not a doctor, she's not offering scientific opinion; she's speaking ... as an individual from the heart about what she believes."

A company generally cannot have someone say something for the company that it cannot say under FTC or FDA regulations.   Like Mr. Hiltzik, I am interested in seeing whether POM Wonderful can make that argument stick with the FTC.