Skip 
Navigation Link

1215 South Walnut Ave.
Demopolis, AL 36732 map map 

Access to Care: 1-800-239-2901

Health Policy & Advocacy
Resources
Basic InformationMore InformationLatest News
Many Young Adults Misusing Medical Marijuana, Study SuggestsAnother Possible Effect of Climate Change: More Preemie Babies1 in 18 U.S. Teens Carries a Gun to School: StudyU.S. Poison Centers Field More Calls About Psychoactive Substances: StudyDoctors' Group Calls for Ban on Most Vaping ProductsAs Disease Outbreaks Tied to 'Anti-Vaxxers' Rise, States Take ActionAHA News: Millions Who Never Smoked Cigarettes Are Using Other Tobacco ProductsMost Docs Don't Know Hair Care Is a Barrier to Exercise for Black WomenHealth Tip: Do's and Don'ts for Calling 911Climate Change Will Hurt Kids Most, Report WarnsYou Won't Get Sued If You Do CPR, Review SuggestsRacial Bias Seen in Heart TransplantsTrump Administration Wants to Raise Age to Buy E-Cigs to 21Juul Stops Sales of Mint-Flavored E-CigarettesDo You Take Biotin Supplements? They Could Affect Your Medical TestsClimate Change a 'Threat to Human Well-Being,' Scientists SayAnti-Vaxxers Find Ways Around States' 'Personal Exemption' BansMedia Reports on Celeb Suicides Could Trigger CopycatsStill Way Too Much Smoking in Movies Aimed at KidsConsumers' Orders Changed Slightly After Calorie Counts Added to MenusReport Finds Americans' Health Is FlaggingAfter Mass Shootings, Docs Even Less Likely to Mention Gun SafetyBan on Sale of Sugary Drinks Trimmed Employees' WaistlinesAre You Accessing All Your Medical Records Online?Independent Pharmacies Are Closing Down Across the U.S.Language Barriers May Mean Repeat Visits to the HospitalInterest in CBD Products Keeps Soaring, but Health Experts WaryJuul Halts Sale of Fruit, Dessert Flavors of E-CigarettesShrinking Youth Group Aids Global Decline in HomicidesWhen Meds Are Free, Patients Take Them More OftenSpurred by Mass Shootings, More Americans View Mentally Ill as ViolentPacemakers, Insulin Pumps Could Be Hacking Targets: FDAAHA News: Make Neighborhoods Green for Heart Health? The Idea Is Taking RootPoll Finds Many Young Americans Think Vaping is SafeWhat Do Hospital Cyber Attackers Want to Know About You?U.S. Minorities' Recent Health Gains May Be SlowingPaid Family Leave Helps Keep Babies' Vaccines on Track: StudyDon't Let Fear of Cancer Keep You From Doctor VisitsMaker Halts Distribution of Generic Zantac Due to Possible CarcinogenCould Profit Be a Factor in Kidney Transplant Decisions?Get Up-to-the-Minute Safety Alerts Sent Straight to Your InboxPurdue Pharma to Settle Opioid Crisis Lawsuits, May Pay Up to $12 BillionDocs Prescribe More Opioids at Certain Time of DayFDA Warns Juul About Illegal Marketing Claims and Pitch to YouthComing Soon: A 'Pot Breathalyzer'?More CT, MRI Scans Being Used, Despite Calls to Cut BackCancer Overtakes Heart Disease as #1 Killer of Middle-Aged in Wealthy NationsOxyContin Maker Purdue Offering Up to $12 Billion to Settle Opioid ClaimsThousands of Kidneys Thrown Away by U.S. Transplant CentersJudge Orders Johnson & Johnson to Pay $572 Million Over Opioid Drug Crisis
Questions and AnswersVideosLinksBook Reviews
Related Topics

Health Insurance
Healthcare

FDA to Tighten Oversight of Supplements

HealthDay News
by -- Robert Preidt
Updated: Feb 11th 2019

new article illustration

MONDAY, Feb. 11, 2019 (HealthDay News) -- The U.S. Food and Drug Administration plans to strengthen regulation of dietary supplements, such as vitamins, minerals and herbs, the agency announced Monday.

The changes would be "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years," FDA Commissioner Dr. Scott Gottlieb said in an agency news release.

Three out of every four Americans take a dietary supplement on a regular basis, including one in three children. The rate is highest -- four in five -- among older Americans.

"What was once a $4 billion industry, comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 -- and possibly as many as 80,000 or even more -- different products available to consumers," Gottlieb said.

"As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products, or making unproven or misleading claims about the health benefits they may deliver," he noted.

The Council for Responsible Nutrition, a trade association that represents the nutritional supplement industry, took no issue with the FDA's action.

The group said it supports "Dr. Gottlieb's enthusiasm for rooting out bad actors who put consumers at risk by spiking products with unapproved ingredients or drugs," said Steve Mister, president and CEO of the council. "We welcome additional enforcement actions to bring to justice those who would cynically trade on the halo effect of responsible industry to make a quick buck while ignoring the safety and health of consumers."

Gottlieb added that he's concerned that "changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks."

The new measures include "communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders," Gottlieb said.

The agency took a first step toward that end Monday, when it sent 12 warning letters and five online advisory letters to companies illegally selling or marketing unapproved products that claim to prevent, treat or cure Alzheimer's disease, and a number of other serious conditions.

"Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer's," Gottlieb said.

But enforcement actions are just one part of the FDA's efforts to update its policies on dietary supplements.

"I recently directed the establishment of a Dietary Supplement Working Group at the FDA, led out of my office and comprised of representatives from multiple centers and offices across the agency," Gottlieb said.

He said the FDA's priorities for dietary supplements are to ensure they're safe, contain the ingredients listed on the label and are made according to quality standards.

Gottlieb also said the FDA is "developing a new rapid-response tool to alert the public so consumers can avoid buying or using products with [dangerous ingredients], and to notify responsible industry participants to avoid making or selling them."

The FDA is improving the efficiency of enforcement actions when dietary supplements contain illegal ingredients, including drug ingredients.

The agency will also update its compliance policy regarding dietary ingredient notifications, to better evaluate the safety of a new ingredient before it becomes available to consumers. In addition, the agency will hold a public meeting on the responsible development of new products in the dietary supplement industry.

Another measure announced Monday is the creation of the Botanical Safety Consortium, a public-private partnership that will include leading industry, academia and government scientists "to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements," Gottlieb said.

The FDA will also seek public input on whether further measures are needed to modernize the Dietary Supplement Health and Education Act (DSHEA), which gives the FDA the authority to regulate dietary supplements, Gottlieb said.

More information

The U.S. Office of Dietary Supplements has more on dietary supplements.