Health and Health Care in Schools
Vol 6, No 11 - February 2006


Survey Finds Increase in Drug Use Before Age 13

Of the approximately 1.8 million persons who were admitted to substance abuse treatment facilities in the year 2003, 14 percent said they began using their substances before they were 13 years old, according to an analysis of admissions released January 26 by the federal Substance Abuse and Mental Health Services Administration (SAMHSA).

That represents an increase in early drug use since 1993, when 12 percent of those applying for treatment reported they had begun using their substances before age 13. The increase in early use was especially noticeable in the case of marijuana and opiates such as prescription pain medications and heroin. The only good news, SAMHSA said, is a slight decline over the 10-year period in the number of early users of cocaine and stimulants such as methamphetamine.

SAMHSA finds the rise in numbers of very young persons who are using drugs alarming. "Age at first use is an important predictor of the potential for serious substance abuse problems later in life," said SAMHSA Administrator Charles Curie. "The increase in the proportion of admissions for drug use before age 13 should be a wake-up call to parents to speak to their children early and often about the dangers of drug use."

The SAMHSA figures include only persons who entered treatment for addiction to drugs other than alcohol, and it does not include adults who may be addicted but do not seek treatment.

A 2005 questionnaire completed by 8th, 10th, and 12th graders as part of the annual Monitoring the Future survey confirmed that many young people, by the time they reach 12th grade, are regular or occasional users of prescription medications such as Vicodin and OxyContin and also of sedatives/barbiturates.

The survey found some decline in overall drug use by teens and adolescents in 2005, but the director of the National Institute of Health’s National Institute on Drug Abuse (NIDA), Dr. Nora Volkow, noted that "the upward trend in prescription drug abuse is disturbing. Prescription drugs are very powerful medicines that are effective when used properly and under a doctor’s supervision. Using these drugs without a prescription is dangerous. It’s important that teens get this message."

The full text of the SAMHSA report, "Age of First Use Among Admissions for Drugs, 1993 and 2003," is available online at www.oas.samhsa.gov. The website of the Monitoring the Future survey is http://monitoringthefuture.org.

For charts prepared by the National Institute on Drug Abuse describing commonly abused drugs and prescription drugs with potential for abuse, see pages 6 and 7 of this issue.

See also: CHHS Parents Resource Center: Substance Use, Other at
http://www.healthinschools.org/parents/substance.htm and
How Good Are the Best Adolescent Substance Abuse Treatments? at
http://www.healthinschools.org/ejournal/2004/oct4.htm

Screening High School Students for Suicide Risk: A Report on the Suicide Risk Screen

A screening instrument that found 29 percent of the students who took it at risk of committing suicide overwhelmed school staffs and led to discontinuance of the survey after two semesters, according to a report in the February 2006 issue of the American Journal of Public Health. That indicates a need for a "simpler, more specific" instrument than the current Suicide Risk Screen, researchers concluded.

That suicides among youths are a source of significant and preventable loss of life is unquestioned, the report points out. Suicide is the third leading cause of death among youths aged 15 to 19 years, accounting for approximately 12 percent of the deaths in this age group. A biennial Youth Risk Behavior Surveillance Survey conducted by the Center for Disease Control and Prevention (CDC) found that in 2003, 17 percent of high school students had seriously considered attempting suicide and nearly 9 percent had attempted suicide in the preceding 12 months.

The researchers also agreed that identifying and helping teenagers who have contemplated or may consider suicide is an important school function. "An effective population-based strategy to prevent adolescent suicide should include a school-based approach, given that such an approach is the most efficient way to reach large numbers of young people."

The researchers note that suicide screenings in schools may face "significant resistance" from both high school principals and high school psychologists. Other potential "real world" barriers including insufficient staffing and budgets, scheduling issues, legal concerns, and potential negative responses from parents and students.

Specifically, the researchers examined the Suicide Risk Screen (SRS), a screening instrument embedded in the High School Questionnaire (HSQ), which includes items that assess school deviance and connectedness; peer bonding; family support; emotional issues such as self-esteem, stress, anxiety, hopelessness, and personal control; high-risk behaviors; substance use; suicide; and demographic variables such as age, gender, grade, ethnicity; and family structure. The SRS focuses on sets of rank-ordered criteria based on confirmed suicide risk factors.

The developers of the SRS concede that the instrument may deliver a large number of false positives, but they argue that tolerance of false positives is necessary because of the seriousness of missing a single suicidal individual.

But the very large numbers of students flagged as at risk by the SRS, and the possibility that many of those might in fact be false positives, was the chief difficulty encountered by the two school districts in the research study. School staff were overwhelmed by the need to follow up and counsel more than one-quarter of their students, and they were reluctant to alarm parents by giving them the SRS results, if the findings were incorrect. At the end of the two semesters of the study, both school districts decided they no longer wanted to participate in the suicide screening, and it was dropped from the HSQ and the study.

During the period in which the study was conducted, one young person in each of the two school districts committed suicide. Neither had been participants in the screening program, but researchers noted that the deaths "underscored the seriousness of the problem."

They concluded that: "We believe that the SRS’s low specificity results in too many false positives." Instead, what is needed, they said, is a simplified instrument that identifies only students who have attempted suicide in the past year, who are at high current levels of suicide ideation, or who are at high current levels of depression and exhibit any degree of suicidal ideation.

The report, "Feasibility of Screening Adolescents for Suicide Risk in ‘Real World’ High School Settings," by researchers primarily from the Pacific Institute for Research and Evaluation, Chapel Hill, NC, and the University of North Carolina, appeared in the February 2006 issue of the American Journal of Public Health. Requests for reprints should be sent to hallfors@pire.org.

See also: CHHCS Parents Resource Center: Suicide and Suicide Prevention at http://www.healthinschools.org/parents/suicide.htm and Examining the Tragedy of Youth Suicide at
http://www.healthinschools.org/ejournal/2004/july2.htm

Marketing to the Young: The Tobacco Industry and Flavored Cigarettes

It’s one of the most innovative industries, and big tobacco hasn’t given up on efforts to recruit young smokers, despite controls imposed in recent years on advertising and promotion to the under-18 age group. A recent development—the introduction of flavored cigarettes as line extensions of three popular brands (Camel, Salem, and Cool)—has raised concern in the public health community that this marketing strategy is targeted at youths.

That’s not hard to imagine. Studies conducted in 2004 showed that the three flavored products are smoked by 20 percent of 17- to 19-year-olds but by only 6 percent of smokers over age 25, with Camel Exotic Blends used more commonly than the other two. Researchers at the Department of Health Education and Behavioral Science at the University of Medicine and Dentistry in New Jersey looked into the history of flavored cigarettes and their effects on young people and reported their findings in the February 2006 issue of the American Journal of Public Health.

For one thing, the best-selling Camels have been available since 1999 in fruit flavors including berry, lime, coconut, and citrus; sweet flavors such as vanilla, cinnamon, chocolate, mint, and toffee; and alcohol flavors such as bourbon. And innovation doesn’t stop with the cigarettes themselves; the tobacco companies have given attention to the packages in which the cigarettes are sold, aiming at a distinctive and graphically appealing image that will come to mind every time the package is opened. "Camel’s Exotic Blends come in embossed foil-wrapped lining paper within elegant and sleek colored tins, following the traditional style of luxury cigarette packaging."

To spread the word about these products, tobacco companies advertise them in a variety of ways, including in-store promotions, magazine ads, direct mail, themed parties at bars and clubs, and interactive Web pages. In light of recent restrictions on marketing to under-age young people, there is considerable reliance on point-of-sale promotions—posters, signs, and other displays.

The researchers speculated about the effects of all this carefully targeted imagery on the possibility that young people will start and continue smoking. They note that tobacco companies maintain that flavored cigarettes are being marketed to adults 18 to 24 years old, the youngest legal targets and a group not protected by the recent tobacco settlements that forbid advertising to children. Whether as the result of so much advertising, or not, the 18-to-24s are the one age group for which smoking prevalence has not fallen in recent years. And there are other benefits to the industry: "Tobacco companies recognize the importance of the youth and young adult market because brand preferences are established early in life, often with the first cigarette."

Also important, the researchers note, is the probability that tobacco companies see targeting young adults as "doubly beneficial" in that it both captures 18- to 24-year-olds and influences teens who may seek to emulate their older peers. It is that possibility that most alarms public health and tobacco control advocates, who say that these "candy-flavored" products target very young people, masking the taste of tobacco for new users, 90 percent of whom are teenagers or younger, and persuading them to take up the habit. "Review of previously secret tobacco documents has shown that the tobacco industry sees the process of becoming a smoker as something that begins in the teen years and extends into adulthood. In other words, getting someone to initiate smoking is just the first step: producing a pack-a-day addicted smoker requires nurturing."

Many questions remain about flavored cigarettes, including what young people really think about the advertising aimed their way and whether flavored cigarettes are being smoked in addition to or in place of regular brands. But it’s pretty much agreed that tobacco companies will continue to research and promote strategies to protect their bottom line, including recruiting new smokers, and "For this reason, public health practitioners need to be aware of tobacco industry product development and marketing tactics in order to address and counter their potential impact."

The research report "Dealing With an Innovative Industry: A Look at Flavored Cigarettes Promoted by Mainstream Brands" appeared in the February 2006 issue of the American Journal of Public Health. Requests for reprints can be sent to lewismj@umdnj.edu.

See also: Tobacco Companies Urged to Continue Youth Anti-Smoking Campaign at http://www.healthinschools.org/ejournal/2005/march3.htm and
Kids & Teens: Alcohol, Tobacco, & Drugs at
http://www.healthinschools.org/students/drugsteens.htm

Drug Companies Caution on Pandemic Vaccines

In a congressional hearing January 31, pharmaceutical companies described the current state of influenza vaccine production and warned that unless more is done to increase production, they will not be able to provide a vaccine against avian influenza in time to prevent a worldwide pandemic of that disease.

The hearing, called by the Senate Appropriations Committee’s subcommittee on Health and Human Services, was the latest look at avian flu, which at present is believed to be spread only by infected wild or domestic birds. Health authorities fear, however, that the virus may mutate to become transmissible between human beings, making a pandemic inevitable and devastating.

That may already have happened, said Dr. John Barry of the Center for Environmental Research at Tulane University in New Orleans. "The pandemic may have started two weeks ago and we just don’t know it yet." Or, Barry pointed out, a pandemic may not occur for 20 years, though such events have been cyclical in the past and one seems due within the next four years.

Barry, a resident of New Orleans, puts little confidence in the planning that’s currently going on for such an event. "Few disasters have been as well described in advance and as often warned about as Katrina, and yet Katrina happened." In particular, he said, there seems to be inadequate preparation for the possibility of a pandemic’s coming in waves, possibly starting out as a mild illness but evolving rapidly into one much more lethal.

"If the virus starts out as virulent as it will ever get, that’s one thing and calls for one containment and communication strategy. But if it starts out as a virus so mild that it is clinically indistinguishable from endemic influenza and it takes six to eight months to become virulent, that may call for a different containment strategy. It will certainly call for a different media strategy."

Executive officers of four pharmaceutical companies—Chiron, Hoffmann-La Roche Inc., GlaxoSmithKline, and sanofi pasteur—gave the subcommittee extensive testimony about the fragile state of vaccine production, pointing out that only three companies worldwide make influenza vaccines, and only one of those is located in the United States. All the companies are looking for ways to create vaccine from cells, to avoid the lengthy and problematic methods now used in which influenza viruses are cultured in chicken eggs, but none is close to a breakthrough.

Dan Soland, president of Chiron Vaccines, called the situation "precarious" and pointed out that vaccine production involves significant business risks for companies such as his. He noted that Congress has already taken steps to limit the liability of companies that may be called on to make large amounts of a relatively untested vaccine, saying "any plan to prevent or treat pandemic influenza has the potential to present major liability risks to manufacturers and health care professionals." He said Chiron looks forward to working with Congress to also create a compensation program for individuals who receive the vaccine.

George Abercrombie, president and CEO of Hoffmann-LaRoche, touted the virtues of the company’s Tamiflu, which he called "an effective antiviral medication for use in the prevention and treatment of influenza" that has been shown to have activity against the H5NI influenza strain. He called for stockpiling of antiviral drugs in advance of a pandemic "as the only way to ensure that they are available when and where we need them."

The international nature of influenza vaccine was noted by the president of GlaxoSmithKline, who said his company spent $2 billion in 2005 to expand its flu vaccine manufacturing capacity in Germany and Canada.. The company makes an inactivated trivalent vaccine for seasonal influenza, Fluarix, which was approved for use in adults by the federal Food and Drug Administration (FDA) in 2005 and is marketed in 79 other countries, and it plans to seek FDA approval for another seasonal vaccine, Fluviral, for the 2006-2007 flu season. GlaxoSmithKline also makes an antiviral called Relenza, which is inhaled through a device called a Diskhaler ® to surface cells of the upper respiratory tract. It hasn’t been studied in patients who have H5N1 avian flu, but the company believes Relenza would be effective in treating pandemic illness.

Sanofi Pasteur, the largest of the influenza manufacturers, is headquartered in Lyon, France, but has been producing influenza vaccine for the past 30 years at a facility in the Poconos Mountains, in Swiftwater, Pennsylvania. Vice president Philip Hosbach pointed out that during the flu vaccine shortage of 2004-2005, the company was able to ship seasonal vaccine to virtually any location in the United States within 24 to 48 hours. The company currently has five major pandemic agreements with the U.S. government, including to produce a vaccine based on the currently circulating H5N1 avian virus strain; the company has delivered more than 8,000 "investigational doses" that are being used in trials being conducted by the National Institutes of Health (NIH).

All of the drug company executives complimented the Centers for Disease Control and Prevention (CDC) and Congress for allocating some funding to pandemic preparations, but they said much more public education—and much more money—will be needed to make the nation better prepared than it is today.

In response to the company’s presentations, CDC Director Julie Gerberding agreed, saying CDC is concerned that the avian flu virus now circulating is "as lethal" as the virus that caused the 1918 pandemic and that many people may die before a vaccine against it becomes available.

See also: Avian Flu Fact Sheet
http://www.healthinschools.org/sh/avianflu.asp

Pandemic Flu Planning Checklist
http://www.healthinschools.org/sh/fluchecklist.asp

Children and Influenza
http://www.healthinschools.org/ejournal/2005/dec1.htm

WORTH NOTING

FDA Approves Inhaled Insulin for Treating Diabetes

It comes with many caveats—it isn’t approved for use by children, its effects over long-term use are unknown, it shouldn’t be used by smokers or people with underlying lung conditions such as bronchitis or asthma, and it will probably be very expensive--but an inhaled powder form of recombinant human insulin will soon be available to the more than 5 million Americans who now rely on injected insulin to control their type 1 or type 2 diabetes. The federal Food and Drug Administration announced January 27 that it has approved a product called Exubera, a powdered form of insulin to be inhaled into the lungs through the mouth using a specially designed inhaler. The new drug has been studied in approximately 2,500 adult patients and been found to be safe and effective, the FDA says. It is also more rapid-acting than injected insulin, achieving peak insulin concentrations in a range of 30 to 90 minutes, compared with 60 to 240 minutes for regular insulin. Exubera is manufactured by Pfizer, Inc., which is committed to performing continued long-term studies after the product goes on the market later this year.

See also: Diabetes and Schools
http://www.healthinschools.org/sh/diabetes.asp

Committee on School Nutrition to Hold Final Meeting

A Committee on Nutrition Standards for Foods in Schools will hold its third and final meeting February 13 and 14, with a report expected later in the spring. The committee, which was convened a year ago by the Food and Nutrition Board of the Institute of Medicine, at the request of Congress, is expected to make wide-ranging recommendations concerning all foods available in schools, including ala carte items and snacks in vending machines, as well as the federal school lunch and breakfast programs. Testimony was heard in the committee’s first two meetings from concerned members of the public and representatives of major food companies. Persons wishing to testify at the February sessions in Irvine, CA, should contact the study director at Jokita@nas.edu.

See also: School Lunch & Nutrition: Are your kids eating healthily at school?http://www.healthinschools.org/parents/lunch.htm and

Deadline Looms for School Wellness Policies
http://www.healthinschools.org/ejournal/2005/june3.htm

Study Will Look at Re-Using Surgical Masks, Respirators

The federal Department of Health and Human Services has asked the Board on Health Sciences Policy of the Institute of Medicine to study whether disposable surgical face masks and particulate respirators could safely be re-used in health care settings or by the general public, in the event of an influenza pandemic. The Board notes that in a pandemic, "effective vaccines and anti-viral medications many not exist or may not be available in adequate quantities" and non-pharmacological interventions such as the use of masks "will play an even more critical role in pandemic prevention strategies." Noting that masks and respirators couldn’t be produced fast enough to meet the demand in a pandemic, the government wants to find out ahead of time if those devices could safely be used repeatedly, to stretch the supply. The Institute of Medicine expects to make recommendations early this year.

January News Alerts

The following information appeared during the month of January 2006 in the News Alerts section of the website of the Center for Health and Health Care in Schools, at www.healthinschools.org.

January 9, 2006

CDC Cites Changes in Immunization Recommendations

The director of the National Immunization Program at the Centers for Disease Control and Prevention today pointed to the changes in this year’s Childhood and Adolescent Immunization Schedule, which was released last week. Dr. Anne Schuchat noted that the new schedule:

  • Recommends routine vaccination of children 11-12 years old with a meningococcal polysaccharide diphtheria toxoid vaccine that was licensed in January 2005. The new vaccine offers protection against four of the most common serogroups (A, C, Y, W-135) that cause meningococcal disease.
  • Recommends a booster tetanus, diphtheria and pertussis (Tdap) vaccine to be given in place of the tetanus-diphtheria (Td) booster to children 11-12 years of age and adolescents over age 13 who did not receive the Td vaccine when they were 11 or 12. In addition, all adolescents 11 to 18 years old who have already been vaccinated with Td are encouraged to receive a dose of Tdap at intervals shorter than 10 years to add protection against pertussis (whooping cough).
  • Expands recommendations for annual influenza vaccinations to all children and adults who have neurological conditions that can cause breathing or swallowing difficulties, such as seizure disorders.
  • Recommends vaccination for hepatitis A for all children at 1 to 2 years of age, with children who have not been vaccinated at those ages to receive the shots before school entry. (Previously, hep A vaccination had been recommended only for children living in states with the greatest number of reported cases, but the new recommendation is intended to protect children no matter where they live.)

For the full text of the Recommended Childhood and Adolescent Immunization Schedule for 2006, see the January issue of the newsletter of the Center for Health and Health Care in Schools, available in html or PDF at healthinschools.org.

January 9, 2006
Health Care Spending Reaches New High

National health care spending overall grew 7.9 percent in 2004, compared to 8.2 percent in 2003, with a slight easing of recent growth in spending for prescription drugs, the federal government reported today. But despite those encouraging trends, economists at the Centers for Medicare and Medicaid Services (CMS) cautioned that spending neared $2 trillion in 2004, with health care now accounting for a record 16 percent of the gross domestic product. "The implication is that more of every dollar of output by our country is going to health care," said CMS economist Cynthia Smith. Reporting on the federal share of health care spending, CMS noted that Medicare expenditures rose 8.9 percent to $309 billion in 2004, while Medicaid spending grew 7.9 percent to $293 billion, a smaller increase than in the previous year, largely as the result of states’ efforts to contain prescription drug costs by such means as requiring generics and entering purchasing pools. In the private sector, households spent $557 billion on health care in 2004; hospital spending reached a high of $571 billion; payments for physician services rose to roughly $400 billion; and home health care, while a small chunk of the health care pie, continued to grow faster than any other service category. The 2004 report does not reflect any changes in health care spending that may result from the new Medicare prescription law that went into effect January 1 2006. The report is published in the January/February issue of the journal Health Affairs. Selected articles from the issue are available at www.healthaffairs.org.

January 9, 2006
Cleft Palate, Down Syndrome Most Frequent Birth Defects

In a first-ever effort to determine national incidence of 18 specific birth defects, the Centers for Disease Control and Prevention (CDC) said January 5 that 3 percent of all babies born in the United States are affected by a birth defect of some type, with cleft lip and cleft palate the most common conditions, followed by Down syndrome, which affects about 5,500 babies a year. "Birth defects are a leading cause of deaths in the first year of life," said Jose Cordero, director of CDC’s National Center on Birth Defects and Developmental Disabilities. "With more accurate estimates of how often and where birth defects are occurring, we hope to learn more about how we can prevent them. With improved information, we can better plan for and address the health and education needs of children with birth defects." For more information, visit www.cdc.gov/ncbddd/bd/abc.htm.

January 13, 2006
Most Health-Threatening Behaviors Begin in Youth, Study Finds

By the time they reach adulthood, a large proportion of American youth have begun poor life practices—including smoking, overweight, and alcohol abuse--that lead to preventable deaths later in life, according to a study funded by the National Institute of Child Health and Human Development (NICHD). "When they were young teenagers, most of the participants had fairly healthy behaviors," said Christine Bachrach, NICHD’s project officer for the study. "What’s really alarming is how rapidly healthy practices declined by the time the participants reached young adulthood." Calling the trends "quite stunning," investigators noted that diet; physical activity; obesity; access to health care; tobacco, alcohol, and illicit drug use; and the likelihood of acquiring sexually transmitted disease all worsened as youths reached adulthood. "These findings underscore the importance of ongoing preventive efforts early in the life course," they said. The study was reported in the January 2006 issue of Archives of Pediatrics and Adolescent Medicine.

January 16, 2006
Two Antivirals Lose Effectiveness Against Flu

The Centers for Disease Control and Prevention (CDC) confirmed January 14 that two antivirals that have been prescribed in the past to ease the discomfort of seasonal influenza have become resistant to this year’s strain of the flu and should no longer be prescribed. The two drugs—amantadine and rimantadine—were found to be resistant in 91 percent of influenza A virus isolates. That "removes a few tools from our toolbox that we use to combat influenza," said CDC Director Julie Gerberding. The CDC noted, however, that two other antivirals—oseltamivir (Tamiflu) and zanamivir (Relenza)-- remain effective and can be prescribed if antiviral medication is needed for the treatment or prevention of this year’s influenza. The CDC also reported that influenza activity is starting to pick up across the country, with 18 states reporting either widespread or regional activity.

January 18, 2006
Supreme Court Rules on New Hampshire Parent Notification Law

In an opinion handed down today, the United States Supreme Court declined to strike down a New Hampshire parental notification law that requires notification of parents 48 hours before an abortion is performed on a minor, even if the delay puts the health of the minor at risk. The Supreme Court held that lower court rulings that found the entire parent notification law unconstitutional because it lacked a "health exception" were in error and returned the case for the courts and the state legislature to reconsider whether there may be other remedies for the lack of a health exception, such as "carefully crafted injunctive relief." The ruling leaves previous Supreme Court rulings on abortion unchanged; the unanimous opinion written by Justice Sandra Day O’Connor specifically notes that "We do not revisit our abortion precedents today .…" The case was Ayotte v. Planned Parenthood of Northern New England.

January 18, 2006
FDA Says Drug Package Inserts Revised for Clarity, Ease of Use

Announcing the first revision in 25 years of the format drug manufacturers must use for prescription drug information--commonly called the package insert—the federal Food and Drug Administration said today that the new format will make information about medications easier for health care professionals and patients to understand and may help to avoid prescription errors. Some of the most significant changes include a "Highlights" section to be prominently displayed at the top of the page, giving concise information about the benefits and risks of the particular drug, plus dosage and administration information. A new Patient Counseling Information section is designed to help doctors counsel their patients about the uses and limitations of the medication. The new format is needed, said U.S. Surgeon General Richard Carmona, because "Americans are overwhelmed with the complexity of health information. We have hit a point of information overload and the public health message is being diluted." Full information about the new rules is available at www.fda.gov/cder/regulatory/physLabel/default.htm.

January 23, 2006
FDA Warns of ‘Influenza-Preventing’ Products

Warning of public health dangers posed by fraudulent products and practices that claim to treat or prevent seasonal or avian influenza, the federal Food and Drug Administration (FDA) January 20 cited as examples:

  • Drugs have been intercepted at the Canadian border that claimed to be "generic Tamiflu" but actually contained only Vitamin C and other ineffective substances;
  • Individuals have been arrested and/or indicted for administering counterfeit influenza vaccine to employees attending a corporate-sponsored health fair and for attempting to sell to hospitals unlicensed flu vaccine that was smuggled into the country
  • A licensed practical nurse was sentenced to nine months in prison this month for adding saline to increase her supply of flu vaccine administered at a clinic at a college in Minnesota.

"Consumers should be aware that currently there are no approved vaccines for preventing avian flu in people," the FDA pointed out. And although several vaccines and drugs have been approved for prevention or treatment of seasonal influenza, it is often impossible for consumers to differentiate between approved products and those that are not genuine. In general, the FDA advised, influenza-related products that are promoted to consumers without specific endorsement by a registered pharmacy or health care professional and/or without a valid prescription written by a health care professional are not approved by the FDA and have not been determined to be safe and effective.