Updates

Deadline for Supplement Comments

March 13, 1996, is the last day FDA will accept comments on its proposals to standardize the labeling of dietary supplements. The proposals appear in the Dec. 28, 1995, Federal Register.

The address for submitting comments is: FDA Dockets Management Branch (HFA-305), Rockville, MD 20857-0001.

Under one proposal, labeling for dietary supplements would follow the same format as that used in the labeling of packaged foods. It, too, would give nutrition information about certain vitamins and minerals, as well as other dietary ingredients. Instead of "Nutrition Facts," the information would be presented under the heading "Supplement Facts."

Another proposal would set definitions for the terms "antioxidant" and "high potency" as used in the labeling of dietary supplements.

The term "dietary supplements" refers to products containing vitamins, minerals, herbs, amino acids, and other nutrients and ingredients intended to supplement the diet.

The proposals would implement major provisions of the Dietary Supplement Health and Education Act of 1994. Under that law, labeling rules for dietary supplements must be final and in effect by Jan. 1, 1997.

New Regulations for Seafood

A revolutionary way of protecting the U.S. food supply from contaminants could begin this year under new regulations for seafood safety that take effect Dec. 18, 1997.

The regulations, announced by FDA last December, call for seafood processors to adopt food safety practices based on the Hazard Analysis Critical Control Point (HACCP) system. This system uses preventive controls to keep unsafe foods off the market, instead of addressing safety problems after the fact, which has been the approach since the early 1900s.

FDA estimates its HACCP seafood safety regulations will prevent 20,000 to 60,000 seafood poisonings a year, which cost consumers as much as $116 million annually.

Next year, the U.S. Department of Agriculture will issue HACCP rules for meat and poultry, and in future years, FDA plans to issue regulations covering other foods.

Under the seafood regulations, processors must identify hazards that, without preventive controls, are reasonably likely to affect product safety. Examples of food hazards are chemicals, toxins, bacteria, parasites, and physical objects.

If a hazard is identified, the firm must implement an appropriate HACCP plan. For example, a highly mechanized processing line would be checked regularly for metal fragments in the food and records kept of those checks. With the HACCP recordkeeping, FDA inspectors can monitor product safety more closely and on a more continuous basis than with the older "spot-checking" method.

The HACCP seafood regulations have special provisions for certain fish. For example, processors of raw molluscan shellfish, such as oysters, clams and mussels, must specify in their HACCP plans that they will accept only molluscan shellfish harvested from approved waters. For smoked fish, processors must implement procedures to ensure that the product remains safe from Clostridium botulinum toxin through the shelf life of the product.

The HACCP rules do not apply to fishing vessels and transporters. However, processors must take responsibility for their seafood materials, whether imported or domestic. The rules also do not apply to retail seafood operations, which are regulated by state and local authorities who have received training and other technical assistance from FDA.

FDA published the rules in the Dec. 18, 1995, Federal Register.

(For more information, see "HACCP: Patrolling for Food Hazards" in the January-February 1995 FDA Consumer.)

Device Reporting Rule Final

Beginning April 11, hospitals, nursing homes, and other health-care facilities must report medical device-related deaths and serious injuries or illnesses, according to an FDA final rule that also spells out manufacturers' reporting requirements.

The rule requires that medical facilities:

within 10 days, report deaths to FDA and to the manufacturer
within 10 days, report serious injuries or illnesses to the manufacturer, or to FDA if the firm's identity is not known
every six months, send FDA a summary of these reports.

The new criteria, published in the Dec. 11, 1995, Federal Register, are part of a universal "alert system," required by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.

The rule requires that manufacturers:

within five days, report to FDA any device-related incident requiring immediate action to protect the public health, as well as any incident for which the agency requests a report
within 30 days, report other device-related deaths, serious injuries, or illnesses, as well as device malfunctions likely to cause or contribute to death, serious injury, or illness
annually, submit a statement certifying the number of reports filed, or that no reports were filed during the previous 12 months
report incidents related even to products no longer marketed.

The rule helps lower costs by reducing paperwork. Reports can be submitted on the same FDA Medwatch form used for reporting drug- and biologics-related adverse events. Procedures are under way at FDA to allow electronic filing of reports.

Doublechecking Pap Smears

Two new computer-based Pap smear screening systems will help increase the detection of cervical cancer.

Laboratories can use the Autopap 300 QC System or the Papnet system to doublecheck all or a selected portion of Pap smears initially found to be normal.

Pap smears, samples of cervical cells quickly pressed on a glass slide and "fixed" to prevent them from drying and changing appearance, can detect cancer and precancerous cell changes in the cervix. About 50 million Pap smears are done annually in the United States.

Cytotechnologists, specially trained in identifying defective cells, examine the slides under a microscope to look for signs of abnormalities. Although cytotechnologists routinely rescreen 10 percent of all negative (normal) smears, some abnormal smears may go undetected. The error rate for Pap smears varies from lab to lab but is estimated to be from 5 to 25 percent.

The Autopap system makes it possible to rescreen all normal Pap smears. Using image processing and pattern recognition techniques, the device picks out 10 to 20 percent of the most suspicious smears for a second examination.

In the clinical studies conducted at seven laboratories in the United States, the device screened 11,751 Pap smears initially thought to be normal and found 297 that were actually abnormal.

The Papnet system also rescreens normal Pap smears. It selects the 128 most abnormal looking cells or cell clusters from each Pap smear. The cells are recorded on a high-resolution color video monitor for a cytotechnologist to evaluate.

In a clinical trial using Pap smears from 10 different labs, rescreening with Papnet detected 464 abnormal smears out of 9,666 originally diagnosed as normal.

Even with the Autopap and Papnet, however, false negatives may still occur, due to reading errors, sampling and technical errors in handling the smears, or rapidly progressing cancer that cannot be identified during routine screening.

FDA approved the Autopap, manufactured by Neopath Inc. of Redmond, Wash., on Sept. 29, 1995, and Papnet, manufactured by Neuromedical Systems of Suffern, N.Y., on Nov. 8, 1995.

(For more about Pap smears, see "The Controversial Pap Test," in the September 1989 FDA Consumer.)

Faster TB Test

A sputum test for tuberculosis recently approved by FDA gives results in only four to five hours, instead of the one to eight weeks required by conventional sputum culture tests. All tests must be done by qualified laboratories.

The Amplified Mycobacterium TB Direct Test was approved last Dec. 18 for use only on specimens of sputum that an acid fast stain has already shown are likely to be positive for the TB bacteria. Because the new test gives results more quickly, patients can receive antibiotic treatment earlier, and isolation facilities can be used more efficiently. In addition, others who have been in contact with the patients can be tested earlier and given appropriate treatment if necessary. However, a follow-up culture test must also be done to confirm the presence of TB.

The manufacturer, Gen-Probe Inc., of San Diego, studied 6,079 specimens, finding 198 likely to be positive by the acid fast stain and confirmed with culture. The new test detected TB bacteria in 95.5 percent of specimens that had the bacteria.

Recent Drug Approvals

Drugs to treat AIDS, a form of leukemia, Lou Gehrig's disease, and skin damage were among those approved as 1995 drew to a close and this issue of FDA Consumer was being prepared.

Invirase (saquinavir) and Epivir (lamivudine, or 3TC) were both approved to treat HIV infection, including AIDS, under FDA's accelerated approval process, which allows the agency to grant early marketing to products while clinical studies continue.

Invirase is the first approved protease inhibitor, one of a new class of drugs for the treatment of advanced HIV infection. Invirase is approved for use in combination with drugs from the class known as nucleoside analogs, to which five other drugs approved to treat AIDS, including Retrovir (zidovudine, or AZT) and Epivir, belong. The agency approved Invirase only three months after receiving its marketing application. Clinical trials compared three drug combinations in more than 900 HIV-infected patients. Over 16 weeks of treatment, CD4 counts increased an average of 30 to 40 cells in patients taking Invirase in combination with Retrovir or Hivid (zalcitibine, or ddC), or with a combination of Retrovir and Hivid. Invirase is manufactured by Roche Laboratories.

Epivir (lamivudine, or 3TC) is approved for use in combination with Retrovir in treating AIDS and HIV infection. Trials show that patients treated with the combination sustained higher increases of CD4 cells than patients receiving Epivir or Retrovir alone, or Retrovir with Hivid. Epivir and Retrovir are manufactured by Glaxo-Wellcome Inc.

Vesanoid (all trans retinoic acid, or ATRA) is approved to reverse the progression of promyelocytic leukemia in patients who are resistant to or cannot use standard cancer treatment. About 2,500 people in the United States have promyelocytic leukemia, a life-threatening disease associated with a genetic abnormality that causes excessive production of white blood cells. In clinical studies sponsored by the National Cancer Institute, 50 percent of patients who had relapsed following standard chemotherapy had complete remission of the disease when treated with the drug. Vesanoid is distributed by Hoffmann-La Roche.

Rilutek (riluzole) is the first drug shown to prolong the survival of patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. FDA approved the drug 5 1/2 months after receiving the application for approval. ALS is a disease with no known cure that causes progressive muscular weakness and paralysis. It is usually fatal within five years after diagnosis. In clinical tests, Rilutek prolonged the survival of ALS patients by about three months. The drug is manufactured by RhÙne-Poulenc Rorer Inc.

Renova (0.05% tretinoin emollient cream) is approved to assist in treating certain kinds of skin damage, such as fine wrinkles, spotty discoloration, and rough skin. Renova is to be used as part of a comprehensive skin care and sun-avoidance program. In studies, after 24 weeks of treatment, about 30 percent of patients had moderate improvement, 35 percent had slight improvement, and 35 percent had no improvement. Renova does not eliminate wrinkles or repair sun damage that can lead to skin cancer. Nor is there evidence that Renova treats coarse skin, deep wrinkles, skin yellowing, or other skin problems. Renova has not been studied in people 50 or older or in those with moderately or darkly pigmented skin. Renova is related to the topical acne medication Retin-A. Both medications are manufactured by Ortho Pharmaceutical Corp.

Sensor Pad Helps Find Breast Lumps

A plastic pad that women, with proper training, can use to examine their breasts for lumps was recently cleared for marketing by FDA.

The Sensor Pad will be available through health-care providers, clinics, and other institutions where women can receive instructions for its use. To ensure early detection of breast cancer, women should continue doing bare hand self-examination and having exams by a doctor and yearly mammograms.

The manufacturer, Inventive Products Inc., of Decatur, Ill., submitted two clinical studies to FDA last November: a U.S. study of the impact of different educational strategies on the skill and frequency of self-exams, and a Japanese study that was part of a self-exam screening program.

The Japanese study of the 832 women showed that women who had been properly instructed in the pad's use detected their own breast lumps almost as frequently as the lumps were found by trained nurses also using the pad. Nurses were able to detect lumps in each of the 72 women identified with breast cancer. Of the same 72, only one missed her breast lump when self-examining with the pad.

FDA cleared the Sensor Pad for marketing last Dec. 22.

FDA Consumer Wins Four Awards

FDA Consumer won four awards in important publication competitions recently.

The magazine was awarded first place among magazines for general audiences in the 1995 National Association of Government Communicators' "Blue Pencil" Competition. NAGC also awarded the magazine second place for visual design, and a second-place writing award for the feature "Stalking the Wild Mushroom" by Marian Segal in the October 1994 issue.

In addition, FDA Consumer received a Silver Award (second place) in the 1995 International Mercury Awards Competition, sponsored by MerComm Inc., a New York-based organization. Magazines competing for the awards include those from many sources, including industry and nonprofit associations.

Food Label Information Wins Prizes

Several of FDA's efforts to inform the public about the new food label have garnered recent awards.

The video "The Food Label and You" received a gold award (first place) in the 1995 International Mercury Awards Competition sponsored by MerComm, Inc. Contestants in the competition include private, industry, nonprofit, and government groups.

A high school teachers' guide, "The New Nutrition Label: There's Something in It for Everyone," received The American Dietetic Association Foundation's Presidents' Circle Award for Nutrition Education last Oct. 31. The guide was a joint effort of FDA and the International Food Information Council.

Two FDA public service announcements, "Check It Out" and the animated "The Fat that Jack Eats," each received a third place award in the 1995 National Association of Government Communicators' "Gold Screen" Competition. Both announcements give information about the new food label.

Free Publications Available

Three backgrounders and three FDA Consumer reprints are now available free from FDA. They are:

Olestra and Other Fat Substitutes (Revised) (BG 95-18)

HACCP: A State-of-the-Art Approach to Food Safety (BG 95-19)

FDA Food Code (BG 96-1) (This replaces a January 1994 backgrounder.)

Not a Cure-All: Eye Surgery Helps Some See Better (FDA 96-1227)

On the Teen Scene: Food Label Makes Good Eating Easier (FDA 96-2294)

Prostate Cancer: New Tests Create Treatment Dilemmas (FDA 95-1220).

To order, write to FDA, HFI-40, at the same address, or fax your order to (301) 827-5308. Include the publication number.

FDA Consumer magazine (March 1996)