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Dietary supplement makers push the FDA to allow peptides and other new ingredients

WASHINGTON (AP) — Makers of dietary supplements are pushing the Food and Drug Administration to expand the types of ingredients they can put in their products, a change that could open the door to more marketing of peptides, probiotics and other trendy wellness offerings.

The FDA was holding a public meeting Friday to discuss its longstanding criteria for dietary supplements and whether they could be broadened to include substances that don’t come from food, vitamins, herbs or other traditional ingredients. FDA officials will hear from industry executives, consumer advocates and academics.

It’s the first such meeting since Robert F. Kennedy Jr. became the nation’s top health official last year. Kennedy has vowed to “end the war at FDA” on dietary supplements, peptides and other products that are popular within his Make America Healthy Again movement.

Friday’s meeting came at the request of the Natural Products Association, an industry group that has clashed with the FDA over certain new supplement ingredients. The group asked for the meeting in a January letter, citing “the cost and uncertainty that arise when regulatory expectations are unclear.”

The FDA’s top food official, Kyle Diamantas, opened the meeting by underscoring the administration’s commitment to “cutting red tape” to lower the industry’s costs.

“The industry has grown tremendously over the last 30 years yet the regulatory framework has largely stayed the same,” Diamantas told attendees.

Here’s what to know about the issue:

Many wellness products don’t qualify as supplements

Under FDA regulations, supplements are deemed to be a category of food, with most of their ingredients coming from plants, herbs and other substances found in the American diet.

That requirement has become a challenge for the industry in recent years as newer wellness products often feature substances that have never been used in food.

Peptides, for instance, are druglike chains of amino acids that have been widely promoted by celebrities and influencers as a way to build muscle and look younger, although there’s little science supporting their use.

Many specialty pharmacies and clinics sell them as injections or IV infusions, but some supplement makers have also begun adding them to capsules, gummies and powders.

Technically, those products violate FDA rules, according to FDA lawyers. The same goes for certain types of probiotics, bacteria-containing products that are pitched to aid digestion and promote gut health.

Companies argue that FDA law, as written, doesn’t specify that all ingredients must come from food.

“The hope of the meeting is that FDA is willing to open up its interpretation of what constitutes a dietary ingredient to allow dietary substances that aren’t already in food,” said Robert Durkin, a former official in the FDA’s supplements program who now consults for companies.

But consumer advocates warn that allowing new ingredients would vastly expand the market for supplements, which the FDA has long struggled to oversee.

“FDA should focus on making the current market safer instead of allowing more chemicals and substances in supplements,” said Jensen Jose, senior regulatory counsel of the nonprofit Center for Science in the Public Interest, in a presentation at Friday’s meeting.

Supplement makers view Kennedy as an ally

Kennedy recently declared himself “a big fan” of peptides, telling podcast host Joe Rogan that he’s personally used them to treat injuries. He also vowed to loosen FDA limits on producing injectable peptides, which have been subject to federal safety restrictions.

Some of Kennedy’s allies and supporters are proponents of the chemicals, including Gary Brecka, a self-described “longevity expert,” who sells peptide injectables, patches and nasal sprays through his website.

Dr. Mark Hyman, another Kennedy friend, sells dozens of dietary supplements, including some claiming to contain peptides, through his website.

Two former health advisers from Kennedy’s presidential campaign also have ties to the industry.

Calley Means, now serving as a senior adviser in the Department of Health and Human Services, co-founded an online platform that helps people spend tax-free health dollars on supplements and other wellness goods.

Dr. Casey Means — his sister and President Donald Trump’s surgeon general nominee — made hundreds of thousands of dollars promoting supplements, probiotics and related products, according to financial disclosure forms.

Supplements have never been subject to strict FDA oversight

The FDA does not review dietary supplements the way it approves drugs and other medical products after confirming their safety and effectiveness. The agency does not even have a list of all the products in circulation.

With some 100,000 or more supplements on the market, manufacturers are legally responsible for making sure their products are safe and truthfully advertised, according to the FDA. Supplements can’t claim to treat specific diseases or medical conditions.

The 1994 law that gave the FDA oversight of the industry also exempted supplement makers from nutrition labeling requirements, under which companies must scientifically support health claims.

Instead, supplement makers can make more general claims, such as that their products maintain or support health and well-being.

Some former regulators think that approach was a mistake.

“It sanctioned unauthorized, implied health claims” said Mitch Zeller, who worked on supplement issues at the FDA during the 1990s. “There are all manner of claims being made on supplement labeling or in advertising that are carefully worded to avoid making a drug or treatment claim.”

Companies can also say their products improve the structure or function of certain body parts, such as strengthening bones. Products making general or specific claims must carry a disclaimer: “This statement has not been evaluated by the FDA.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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Follow the AP’s coverage of the Food and Drug Administration at https://apnews.com/hub/us-food-and-drug-administration.

Don’t Settle for Student Loans to Pay for Online Education

Online college programs are becoming a more popular choice for prospective students, with one study finding that more than 6 million students enrolled in at least one online course in fall 2015. The popularity of these courses can be attributed in part to their flexibility with working adults' schedules, students' ability to progress more quickly through online programs and, oftentimes, cheaper tuition. [See 10 low-cost online bachelor's programs for out-of-state students.]Online degrees can be beneficial to many college students, but some studies have shown online learners complete their programs at lower rates than students at traditional brick-and-mortar campuses. Individuals with student loans but no degree comprise two-thirds of defaulted borrowers. Though these numbers are not encouraging, just like for traditional programs, there are ways to reduce how much you'll need to borrow for an online program to ensure you won't become one of these statistics. 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But don't forget to take advantage of local organizations and your school's financial aid office. Both may offer scholarships that you can't find with a national scholarship search. [Review these 10 sites to kick off your scholarship search.]For instance, organizations like the Elks Club, Knights of Columbus or the Rotary Club typically offer scholarships annually to local students. Just because you're going to school online doesn't mean you're ineligible. Visit your local library for scholarship listings, and ask around town. You might be surprised how many local organizations offer scholarships. While these scholarships typically aren't large, every little bit counts. Each dollar you receive in a scholarship is a dollar you don't have to borrow and pay interest on. -- Work-study: Another option for online students may be work-study awards. Not all students enrolled in online programs are eligible, but students at some schools -- including, for example, SUNY Empire State College and Liberty University -- are. Work-study awards are not given upfront like scholarships and grants. In most cases, they are an offer to earn up to the awarded amount if you secure an eligible work-study job. While there is a misconception that all work-study jobs must be on campus, students can work for off-campus, nonprofit or public employers as long as the work is in the public's interest. You may be able to work for a for-profit employer if the job is relevant to your course of study. No matter who the outside employer is, it will need to have an established agreement with your college for you to receive work-study funds. Remember, to be eligible for federal financial aid, you must be enrolled and pursuing a degree or certificate. If you're not working toward a credential, Pell Grants and work-study won't be option, but you may still be able to take advantage of private scholarships -- just be sure to read the eligibility criteria carefully. [Explore what to know about financial aid in online programs.]-- Pay as you go: One of the great benefits to enrolling online is the flexible schedule, which can allow you to complete your college coursework around your responsibilities. But prospective students often overlook using their part- or full-time job earnings as an option for paying for college. Almost 80 percent of college students in 2015 worked at least part time while attending classes, according to the National Center for Education Statistics. By budgeting and thinking strategically about your college costs, you can likely reduce your dependence on student loans by paying a portion out of pocket. Many -- but not all -- online programs are less expensive than traditional programs and often have shorter payment periods. Six, eight or 10 weeks are common course durations. Because of the frequency of payments in an online setting, you may be well-placed to pay as you go and possibly avoid borrowing altogether. Attending college online and avoiding student loans may be challenging, but if you are willing to put in the effort, you can limit the amount you need to borrow. More from U.S. News Q&A: Understanding Student Loan Discharge Eligibility Student Loan Refinancing Isn't Right for All Borrowers
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