News Watch: GMP Inspections Finding Lack of ID Testing

December 1, 2010

GMP Inspections Finding Lack of ID Testing

GMP Inspections Finding Lack of ID Testing

One-third of FDA’s Good Manufacturing Practices (GMP) dietary supplement facility inspections have so far found “serious problems” in large part related to lack of ingredient or material identity testing, said FDA principal deputy commissioner Joshua Sharfstein, MD. Sharfstein was the guest speaker on October 1 at the Council for Responsible Nutrition’s (Washington, DC) annual conference in Austin, TX.

Other violations he noted include failing to establish adequate recordkeeping and quality-control plans, and a lack of end-product testing. He confirmed that FDA planned to conduct 250 inspections by the end of this year and that the agency hopes to double that number in 2011.

Sharfstein also answered audience questions about new dietary ingredient (NDI) draft guidance, which many industry members believe FDA may release in the near future. However, he declined to disclose FDA’s progress or deadline in releasing a draft guidance.

Sharfstein did indicate that FDA would be open to industry feedback once a guidance is released. “Anything we do is going to be a draft…we will very much be listening to what people are saying,” he said, reassuring attendees that the agency would not be seeking to alter the greater scope of the Dietary Supplement Health and Education Act. “I think we’re looking for a nice, narrowly crafted solution,” he stated.

NPA Eyes New Faces in Washington

Following November’s elections, dietary supplement industry members should make efforts to get to know new Congress members, advises Natural Products Association (NPA; Washington, DC) executive director and CEO John Gay.

“NPA will be reaching out to the newly-elected members of Congress and their staffs to begin educating them, but we need the industry’s help,” said Gay. “The more these new Representatives and Senators hear from their constituents about the value of the industry, the better.”

“The natural products sector has champions and threats coming from both sides of the aisle, so the fact that one party or the other is in control does not make or break us-the champions and a number of threats remain,” he added.

Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), both advocates of the dietary supplement industry, were victorious in retaining their Congressional seats for another term. Senator John McCain (R-AZ), who made industry news in February in announcing his Dietary Supplement Safety Act (later withdrawn), also won his race.

Industry Sees Sharp Uptick in Prop 65 Notices

Proposition 65 notices served to supplement companies have skyrocketed this year, said presenters at an October American Herbal Products Association (AHPA; Silver Spring, MD) webcast.

Most notices have been filed by a single private plaintiff, an organization called the Environmental Research Center. More than 100 supplement companies had received 60-day notices in the four months preceding October 18, alleging that products may contain lead, and in some cases arsenic, while failing to provide warnings to consumers, said AHPA.

AHPA president Michael McGuffin added that the number of notices filed in the last four months nearly equals the number of notices filed over the entire past decade.

“We expect that this plaintiff will continue to be very active going forward,” said presenter Melissa Jones of Greenberg Traurig LLP.

California’s Prop 65 is intended to protect consumers from chemicals known to cause cancer, birth defects, or other reproductive harm. It requires products that may contain such chemicals to carry warnings on their labels. More than 850 chemicals are currently on the Prop 65 list.

McGuffin said that most filings have addressed large-format products, such as diet shakes, protein powders, and nutrition bars, for which there is a greater likelihood of finding higher levels of trace contaminants. However, he warned that notices have also been served to smaller-format products, such as capsules and tablets.
    
Supplements Usage Remains Steady

Sixty-six percent of U.S. adults say they use supplements, while 74% call themselves regular users, according to CRN’s 2010 Consumer Survey on Dietary Supplements. These percentages reflect a slight increase over 2009, when 65% of consumers said they took supplements and 73% classified themselves as regular users.

“It’s encouraging that during these tough economic times, consumers are maintaining their supplement regimens; it’s clear that year over year they still place value on these products,” said Judy Blatman, CRN’s senior vice president of communications.

The survey was funded by CRN and conducted by Ipsos Public Affairs between August 17 and September 22, 2010. It surveyed 1989 U.S. adults.

FTC to Alter Green Guides

In October, the FTC released proposed revisions to its Green Guides, first issued in 1992 and last revised in 1998. The guidelines aim to prevent marketers from making misleading environmental claims to consumers.

Understanding that the landscape of environmental marketing has changed substantially since 1998, the agency’s updates address claims common in today’s marketplace. Changes cover the use of product certifications and seals of approval, renewable energy and materials claims, and carbon-offset claims, as well as general usage of terms such as eco-friendly.

The public comments period was scheduled to close on December 10.

SupplySide West Awards Ingredient Science

Pycnogenol, EpiCor, and DeltaGold were the three ingredients singled out this year by SupplySide West’s Scientific Excellence Awards, presented at the trade show in October.

Geneva-based Horphag Research was recognized for the 40 years of research, including more than 85 clinical studies, it has devoted to Pycnogenol, its French maritime pine bark ingredient.

Embria Health Sciences’ (Ankeny, IA) EpiCor immune-health ingredient was also honored for its significant scientific substantiation, including a clinical trial published this year in the Journal of Alternative and Complementary Medicine that demonstrated that Epicor significantly reduced cold- and flu-like symptoms in non-vaccinated subjects.

DeltaGold, a tocotrienol ingredient derived from annatto by American River Nutrition (Hadley, MA), also won an award. This July, the company presented the results of a study of DeltaGold on pancreatic and melanoma cancer cells.

Zeaxanthin Association Calls for Standardization

Members of the Zeaxanthin Trade Association have adopted an analytical method to measure the specific zeaxanthin isomers present in any dietary supplement or food containing the ingredient.

Only three zeaxanthin steroisomers-3R, 3’R; 3R, 3’S; and 3S, 3’S-should be present in dietary supplements and foods with zeaxanthin, according to the association. Furthermore, 3R, 3’R is the only isomer approved for zeaxanthin dietary supplements.

The association’s initiative is an attempt to make positive that all zeaxanthin ingredients comply with current GMP standards and FDA and EU regulations. The method was developed in a six-month study by chemists from association members DSM Nutritional Products, Kalsec Inc., and Chrysantis Inc.

Canada Adds BPA to List of Toxic Substances

Just weeks after the European Food Safety Authority (EFSA; Parma, Italy) in October reaffirmed the safety of consuming tolerable amounts of bisphenol-A (BPA), the Canadian government ordered that the substance be added to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA, 1999).

BPA is a chemical compound derived from polycarbonate plastics and epoxy resins and is found in a variety of food and beverage products, including water bottles and food cans.

Health Canada (Ottawa) affirmed that its scientific assessment “…indicates that there is reasonable and increasing evidence from animal studies to suggest cause for concern and justification for the application of precaution.”

Placing BPA on the List of Toxic Substances allows the Minister of the Environment to initiate regulations and/or instruments for prevention and control of BPA pollution. The Minister has initiated a 60-day commenting period after which any prevention procedures may be implemented.

Meanwhile, EFSA stated in October that there is no reason to fear BPA if it is consumed according to EFSA’s established tolerable dietary intake, which is currently listed at 0.05 mg/kg of body weight.