Tag: Labeling and Labels (Product)

Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug

Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.

How an Unproven Alzheimer’s Drug Got Approved

Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.

Many Alzheimer’s Experts Say Use of Aduhelm Should Be Sharply Limited

Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.

A new drug for the treatment of Alzheimer’s disease should be given to a much narrower group of patients than the federal approval permits, Alzheimer’s experts — including those who strongly supported approval of the medication — said on Monday.

Since the Food and Drug Administration approved the controversial and expensive drug, Aduhelm, made by Biogen, this month, much discussion has focused on the fact that many scientists, and the F.D.A.’s own independent advisory committee, say the evidence does not convincingly show that the drug works.

But another major issue has received less attention: which patients should receive the drug and what doctors should do to prescribe it responsibly and safely.

The F.D.A. has so far imposed strikingly few limitations on Aduhelm, a monthly intravenous infusion that requires patients to have regular M.R.I. scans because the drug can cause swelling or hemorrhaging in the brain.

While the only patients who received the drug during clinical trials were those with very mild Alzheimer’s or an even milder pre-Alzheimer’s impairment, the F.D.A.’s label for Aduhelm says simply that the drug is “for the treatment of Alzheimer’s disease.” Under “contraindications,” the term for health conditions or other characteristics that should prevent patients from taking a drug, the label says “None.”

The broadness of the label has surprised and concerned even the biggest champions of the drug.

“Oy,” said one enthusiastic supporter of Aduhelm’s approval, Dr. Stephen Salloway, describing his reaction “when I saw from the label that there are no contraindications.”

Dr. Salloway, director of neurology and the Memory and Aging Program at Butler Hospital in Providence, R.I., spoke on Monday in a forum sponsored by the Alzheimer’s Association, a large patient advocacy group that pushed for approval of the drug. He and the five other experts answering questions about the use of the drug emphasized that the use of Aduhelm should be limited to certain patients: those in early stages of the disease whose brains contain high levels of amyloid, a protein that clumps into plaques in people with Alzheimer’s disease.

The panelists, who had varying opinions about whether Aduhelm should have been approved, agreed that the drug’s potential brain side effects must be monitored carefully and that doctors should disclose to interested patients that there are many unknowns about Aduhelm, including whether it can provide any benefit.

Aduhelm was designed to slow the progression of memory and thinking problems in people with mild cognitive symptoms, but its approval has been contentious. A number of scientists objected because only one of two clinical trials showed any hint of benefit, and in that trial the high dose of the medication slowed cognitive decline only slightly — by about four months in an 18-month period.

Dr. Salloway, a site principal investigator for trials of the drug, wasn’t paid for that work but has received research and consulting fees from Biogen. He said doctors should use the drug only for patients whose statuses match those in the clinical trials.

“There’s no evidence that it could be beneficial for any other stage of Alzheimer’s,” he said.

Mary Sano, director of the Mount Sinai Alzheimer’s Disease Research Center in New York City, said the criteria that she and other panelists outlined were “very important” and meant that “it’s going to be very restrictive and the ability to share this drug with a wide range of people will be significantly limited, at least at this time.”

Treating people only with mild symptoms would mean that for dementia clinicians, “most of your people in your current practice are probably not eligible,” Dr. Sano said.

In its decision, the F.D.A. acknowledged that there was not the level of evidence of benefit that the agency usually requires. As a result, it is making Aduhelm available under a program called accelerated approval, citing the drug’s ability to reduce levels of amyloid in the brain. But reducing amyloid is not the same thing as slowing symptoms of dementia. Many amyloid-reducing drugs have failed to slow decline in clinical trials, a history that makes some experts especially wary of placing confidence in Aduhelm based on the evidence produced so far.

Given the agency’s emphasis on amyloid in its approval decision, and the fact that all of the clinical trial participants had to have high amyloid levels, experts have also been surprised that the F.D.A. label does not require patients to be screened for the protein. Doctors at the Alzheimer’s Association forum all said that high levels of amyloid, typically measured by PET scan or spinal tap, should be a condition of treatment.

Several of the panelists said that, at least at the outset, relatively few doctors and clinics would have the ability to adequately diagnose, screen and treat patients.

“This is not a simple medication to use,” said Dr. Paul Aisen, director of the Alzheimer’s Therapeutic Research Institute at the University of Southern California and a co-author of an article that urged the F.D.A. to approve the drug. “I think that establishing the appropriate individuals for treatment, and monitoring treatment, requires knowledge and benefits from experience, and there are very few clinicians who have this experience.”

The panelists devoted considerable discussion to the possibility of brain swelling and hemorrhages, which occurred in about 40 percent of participants who received the high dose in the two large clinical trials. Many cases were mild or asymptomatic, but Dr. Alireza Atri, director of the Banner Sun Health Research Institute in Phoenix and another co-author of the article supporting approval of the drug, said that it was possible that “one out of 200 or 300 individuals can have a serious side effect and need to be in a hospital.”

Dr. Salloway said that it would be “more challenging” for doctors to safely monitor for brain side effects than it was within the strict standards of the clinical trials. He said that people should not be given the drug if they have had a macro-hemorrhage in the brain; more than five micro-hemorrhages; a significant stroke; or “unstable medical conditions that could interfere with treatment.”

Dr. David S. Knopman, a clinical neurologist at the Mayo Clinic and a site principal investigator for one of the trials, who did not support approval, said people who were taking blood thinners should also be excluded.

“We know that this treatment carries considerable risks,” said Suzanne Craft, co-director of the Roena B. Kulynych Center for Memory and Cognition Research at the Wake Forest University School of Medicine. And assessing how and whether it helps patients could be tricky, Dr. Craft and others said.

It will be important to have comprehensive discussions with patients and families about “how to weigh the inconvenience and cost and risk against the possible benefit,” Dr. Aisen said.

“Managing expectations is a huge challenge here,” he said, adding that “our expectation is a modest slowing of the rate of decline. It is impossible to determine on an individual patient level whether someone is benefiting or not.”

Are Natural Deodorants Better for You?

Much of the marketing suggests that they’re safer than more traditional underarm products, but that hype is not based on science.

Google “natural deodorant” and you’ll find countless articles detailing all the reasons you should buy them. Some claim that the aluminum in most conventional antiperspirants can lead to Alzheimer’s disease or cancer. Others assert that certain ingredients in traditional deodorants and antiperspirants are “toxic,” or that they can kill off the “good” bacteria in your armpits.

Many natural deodorant companies have seized on these perceptions, implying in their marketing that the ingredients in conventional deodorants are the “stuff you don’t want,” and that what you do want is their “natural” product that is made from “plant- and mineral-based odor fighters” and “clean ingredients.”

But experts, including an oncologist, an epidemiologist, a skin microbiome expert and several dermatologists, said that there is no definitive evidence that regular deodorants or antiperspirants are worse for your health than natural deodorants. In fact, they said, they’re perfectly safe.

And while natural deodorants might contain seemingly healthier ingredients than your conventional drugstore antiperspirant, they can still have substances that might irritate your skin. In the end, the experts said, the way a deodorant makes you feel (and smell) should guide your decision to use it.

Are natural deodorants better for you?

No. One of the biggest and most alarming false claims made about conventional antiperspirants is that they cause breast cancer — a rumor that began with an email chain letter from the 1990s. It said that antiperspirants, which minimize perspiration by blocking sweat ducts, prevent the armpit area from “purging toxins,” which could build up in “the lymph nodes below the arms” and cause cell mutations and ultimately breast cancer. The letter also claimed that razor nicks from shaving could further increase breast cancer risk by allowing chemicals from antiperspirants to enter the body.

This, say experts — including those from the American Cancer Society — is false. “To date, there’s absolutely no evidence that breast cancer is caused by exposure to anything in antiperspirants or deodorants, full stop,” said Dr. Harold Burstein, a breast oncologist at the Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School.

The same goes for another cancer-related rumor, which is that the aluminum from antiperspirants could be absorbed into the skin and increase breast cancer risk by altering breast cell estrogen receptors. Again, Dr. Burstein said, the evidence just isn’t there to support this idea. “The well-done human studies have really never suggested this,” he said, and the studies that have were often performed on animals or cells (like breast cancer cells in a petri dish) and used “unbelievably toxic levels” of the ingredients they were testing.

Anyway, Dr. Burstein added, only a minuscule fraction of aluminum can be absorbed through the skin, so your exposure to it from an antiperspirant is trivial.

There’s also been concern derived from decades-old research that found that Alzheimer’s patients’ brains had high levels of aluminum. This suggested that the metal — perhaps not only from antiperspirants, but also from other personal care and household products like pots and pans — could be a potential risk factor for this degenerative disease. But scientists now disregard the idea that aluminum can cause Alzheimer’s. “The evidence is of poor quality, generally speaking,” said Amy Borenstein, a professor of epidemiology at the University of California, San Diego, who studies the causes of Alzheimer’s disease. “The whole topic has kind of been abandoned.”

She did note that the link between aluminum and Alzheimer’s is challenging to study because aluminum is the third most common element in the Earth’s crust, which means that everyone is exposed to it in small quantities.

“We believe it’s important for people to have choices to find the everyday products that are right for them,” said Justin Boudrow, a spokesman for Tom’s of Maine, which makes a variety of natural personal care products including toothpastes, mouthwashes, soaps and underarm products. “This is why we offer natural deodorants without aluminum that provide odor protection, as well as antiperspirants that do contain aluminum for wetness protection.”

Are natural deodorants good for your microbiome?

There isn’t enough evidence to show that they are. There have been claims that regular deodorants and antiperspirants can disrupt or kill off the “good” bacteria living in your armpits, leading to skin irritation, redness, bumps and overall poor skin health. Some natural deodorant brands have marketed their products as “microbiome friendly,” claiming that they’re not only good for the health of your skin, but also minimize odor by promoting the growth of “good” bacteria.

But Jack Gilbert, a skin microbiology expert at the University of California, San Diego, said that he wasn’t aware of any rigorous studies that have borne this out. “There’s a lot of associative work, but nothing that definitively links deodorant or antiperspirant disruption of the skin microbiome to skin health.”

Are the ingredients in natural deodorants better than those in traditional ones?

No. Just because a deodorant is labeled “natural” doesn’t mean it won’t contain any problematic ingredients itself. In fact, the term “natural” has no regulatory definition, so its labeling on personal care products is essentially meaningless.

“You can get irritation or allergic rashes, and that’s far and away the more common health issue seen with deodorants — all deodorants, whether traditional or natural,” said Dr. Jennifer Chen, a clinical associate professor of dermatology at Stanford Medicine. The most common issue with deodorant is irritant contact dermatitis, or skin irritation, Dr. Chen said, which “usually can’t be pinned down to a specific ingredient, even though some ingredients are more irritating than others.”

The most troublesome ingredient in any kind of deodorant or antiperspirant, whether it’s “natural” or not, is fragrance, said Dr. Nina Botto, an associate professor of dermatology at the University of California, San Francisco. This includes essential oils, which many natural deodorant brands play up in their marketing. “Botanicals, plant extracts and essential oils are often touted as having health benefits,” Dr. Botto said. “But those natural components actually cause a lot of health problems and trouble for the skin.”

The combination of the underarm’s thin, folding skin, hair follicles and moist environment makes this area of the body more susceptible to irritation or an allergic reaction compared to, say, if you put deodorant on your back. In fact, Dr. Chen noted, one study on fragrance allergies found that among many of the scented personal care products tested — like scented deodorants, lotions, shampoos, shaving creams and hair dyes — the deodorants caused the most cases of allergic contact dermatitis, a skin rash caused by contact with an allergen.

Dr. Botto said that while she still sees allergic reactions to synthetic fragrances, she’s been getting more and more patients who are dealing with allergic contact dermatitis after using products with natural fragrance, like those containing linalool and limonene — natural compounds extracted from certain plants, like citrus fruit peels, which are commonly used in natural deodorants.

Even worse, “a lot of times you’ll see that someone gets a rash with a natural deodorant and they’ll put on balms and other ‘natural’ remedies that contain more of the same ingredients,” Dr. Botto said. “It’s kind of like adding gasoline to a fire.” She noted that such rashes can also cause breaks in the skin, which can then lead to infection. “It can be a real mess,” she said.”

Does natural deodorant even work?

The experts said they weren’t aware of any studies that reliably looked into how well natural deodorants work. But the way they’re formulated can offer clues.

Because regular and natural deodorants don’t contain aluminum (which is what helps antiperspirants minimize sweating) they typically rely on ingredients like fragrances and baking soda to mask body odor. This means that natural deodorants generally should function as well as regular deodorants do in terms of keeping you fresh. However, while the experts were not aware of any rigorous, head-to-head studies comparing the efficacy of natural deodorants versus antiperspirants, it stands to reason that they may not counteract smell in the same way that an antiperspirant does. “Bacteria are stimulated to grow by the available water and nutrients found in sweat,” Dr. Gilbert said. “So antiperspirant is getting to the main route of the odor problem.”

Dr. Arielle Nagler, an assistant professor of dermatology at the N.Y.U. Grossman School of Medicine, said that the effectiveness of a product will also depend on how it interacts with your own biology. “Everyone smells a little bit different,” she said, which depends on how much you sweat and what kinds of bacteria are on your body.

Should I buy natural deodorant or not?

Natural deodorant is not better or worse for your health than traditional deodorant or antiperspirant. “A lot of the claims that one product is better than another are just marketing claims that are not based on scientific evidence,” Dr. Chen said. “I don’t think there’s any proof that one is safer than another.”

The Personal Care Products Council, an industry group that represents cosmetic and personal care product companies, echoed a view from Dr. Chen and other experts, which is that people should make their choice based on personal preference. “Our members work to ensure consumers have access to an array of safe and effective products that help meet the differing needs for themselves and their families,” the council said in a statement provided to The New York Times. “This includes offering ‘natural’ products for those consumers who prefer them. It’s all about consumer choice.”

Still, dermatologists do recommend fragrance-free options, especially if you are allergic or sensitive to fragrance. “The more exposure one has to some of these fragrance chemicals, the more at risk you are for potentially developing an allergy,” Dr. Botto said.

If you enjoy using scented deodorants, though, “that’s fine,” she added, “but particularly if you have any sort of skin sensitivity, it’s a risk.”

Or, you could simply choose not to wear deodorant at all.

Annie Sneed is a science journalist who has written for Scientific American, Wired, Public Radio International and Fast Company.

Julia Calderone contributed reporting.

5 Takeaways From the New Food Allergy Law

Sesame becomes a “major allergen,” joining milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans.

If you have a food allergy, or your child does, chances are you spend a lot of time reading labels to figure out whether something will trigger an allergic reaction.

If you’re allergic to sesame, it’s more complicated. While federal law since 2004 has required companies to warn people when certain allergens are used to make a product, sesame has not been one of them. That has meant someone with an allergy to sesame couldn’t know for sure whether the foods they bought at the store were safe.

That is changing. On Friday, President Biden signed into law the FASTER Act, which adds sesame to the list of foods that manufacturers must identify on prepackaged labels. Here are some key takeaways.

Sesame becomes the ninth food to be considered a “major allergen.”

The other eight foods — milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans — were part of legislation that was signed into law in 2004. That law required manufacturers to indicate on labels when a product was made using any of those eight ingredients, describing them as “major food allergens” because they collectively accounted for “90 percent of food allergies.”

If something is made using any of those eight products, you can be certain to find it on the label, either within the ingredients list or nearby with a special “contains” warning — “contains wheat,” for example.

The legislation was a breakthrough for people with food allergies. The right words on a label can be the difference between an uneventful lunch and an allergic reaction — including an anaphylactic one, which can be fatal.

But because sesame wasn’t part of the initial law 17 years ago, companies were not required to include it, making it hard to know for sure whether packaged food contains sesame. According to the Food and Drug Administration, in some cases, sesame is described on the label as “spices” or “natural flavors.”

In the years since the 2004 law was passed, studies have found that sesame allergy is more common than was previously known in the United States. Although it’s much less prevalent than peanut allergy, it is comparable with certain tree nut allergies. Tree nuts were on the original list of major allergens.

Now that the FASTER Act is the law, sesame will need to be included on labels, just like the other eight allergens.

The ingredient must be listed on labels starting in 2023.

It may be a while before you see the effects of the FASTER Act. The law gives manufacturers 20 months to make sure any products they’re making that include sesame reflect that on packaging.

Starting on January 1, 2023, if food contains sesame, you should see it indicated on the label.

In the meantime, if you or someone in your family is allergic, look for ingredients that could be sesame-based, like tahini, sesamol and gomasio, according to Food Allergy Research & Education, a nonprofit organization in McLean, Va. And continue to keep an eye out for “spices” and “natural flavors,” which could include sesame.

It also helps to be aware of the types of foods that tend to include sesame, like falafel, hummus and certain rices. And sesame oil is a common ingredient in Asian cuisine. But keep in mind that sesame can also be found in chips, cereals, snack bars and a variety of other foods.

The good news is that some companies, such as General Mills and Hershey’s, already include sesame on labels when it’s used as an ingredient.

It’s welcome news for over a million Americans.

The new law brings a sense of reassurance to people dealing with a sesame allergy. In the United States, that’s about 1.1 million children and adults, according to a 2019 study published in the journal JAMA Network Open. The study found that less than one quarter of 1 percent of children and adults were estimated to have sesame allergy.

Still, Lauren E. Krigbaum is among the parents who is breathing a sigh of relief. Ms. Krigbaum’s 2-year-old daughter has five different food allergies, including sesame. But until now, sesame had been the only one of her daughter’s allergies that wasn’t part of the federal labeling law.

“When you have a child with food allergies, your life kind of centers around food,” said Ms. Krigbaum, a financial aid counselor in Boise, Idaho. “So being able to take a stress out of that is going to be huge.”

The law will also make grocery shopping easier for adults. The 2019 study, as well as previous studies in 2007 and 2008, found that most children don’t outgrow a sesame allergy. And like other allergies, you can develop it as an adult — about one in four adults who suffer from it developed it after childhood.

The inbox of Lisa G. Gable has been “overwhelmed” with messages of relief. Ms. Gable is the chief executive of FARE, which has been pushing for sesame to be added to the list of allergens.

“It was critically important to get this on the label and we’re excited to have it advancing so quickly with bipartisan support,” said Ms. Gable.

Other allergens still remain off the government’s list.

The new allergen law extends the federal government’s list of “major allergens” to nine foods. But other less common allergens can still go into foods without being printed on packaging.

Other countries have longer lists of allergens required for labeling. Canada has a list of 11 foods, including mustard, required for packaging. Australia’s list comprises 10 foods, one of which is lupin, a type of legume. And the United Kingdom mandates that 14 allergens be declared on labels.

When Nili M. Patel, of Raleigh, N.C., heard about the FASTER Act, she was relieved.

“It was like, finally!” said Ms. Patel, whose 4-year-old daughter has multiple food allergies, including sesame. “The most frustrating allergen for me is sesame because it’s hidden.”

Sesame allergies often appear alongside other food allergies, like peanut, tree nut and egg. Ms. Patel’s daughter is also allergic to certain types of legumes that aren’t part of the labeling law. She said she makes “99 percent” of meals from scratch, including bread, and will continue doing that out of caution.

“I hope that maybe eventually other allergens will make their way into the labeling laws,” said Ms. Patel. “Maybe there’s some hope for that.”

But the law opens the door for future food allergy research and policy.

In addition to the sesame requirement, the new law also has broad implications for food allergies. It says that the Secretary of Health and Human Services must compile a wide-ranging report on food allergies within the next 18 months.

The report should document any work the federal government does related to a spectrum of food allergy issues, including research into the prevalence of food allergies, treatment options and possible prevention methods.

It also calls for “a regulatory process and framework” to determine a food as a “major food allergen,” which could open the door for other allergens to be added to the list.

Dr. Ruchi S. Gupta, a professor of pediatrics at Northwestern Medicine in Chicago, said these sections of the FASTER Act put food allergies on a similar level with other health conditions because it centralizes efforts to monitor food allergies.

“We need to do a deeper dive into what is 10, 11, 12” on the list of top allergens, said Dr. Gupta, a senior author of the 2019 study. “And what is potentially on the horizon to be a bigger problem than it is now.”

How Effective Is the Mask You’re Wearing? You May Know Soon

A C.D.C. division is working with an industry standards group to develop filtration standards — and products that meet them will be able to carry labels saying so.

An App to Deconstruct Your Food

Photo

A screenshot of the Sage app.

A screenshot of the Sage app.Credit

Ever wondered how long you’d have to swim to burn off the calories in an organic peanut butter cup? Or how far the strawberries or burger on your plate traveled to get there?

For answers, ask the Sage Project, one of the latest of the food technology companies helping consumers navigate nutrition. While a number of food apps count calories and track eating habits, Sage goes beyond the food label to give customers additional information about additives and preservatives, how much sugar has been adding during processing or how far a food has traveled.

“Food labels are a data visualization that we see every day, but we don’t get a lot from them,” said Sam Slover, the co-founder and chief executive of Sage. “There are a lot of things about those labels that make assumptions about what you know and what you want to know.”

Do we really need another food app? Apple’s app store already lists more than three dozen apps offering users information and advice about calories, nutrition data and weight loss, but research shows that many consumers have a failed relationship with their food apps. For instance, in January, about 16 percent of the people who downloaded the Lose It app were using it once a day. By June, only 10 percent were using it that often, according to research firm 7Park Data.

“These apps have trouble keeping customers loyal — if you use them successfully, you don’t need them any more, and if you don’t use them successfully, you may not think it’s worth it to try more,” said Byrne Hobart, the lead analyst at 7Park Data. “They’re kind of like the dating apps that way.”

The Sage app hopes to inspire more loyalty by providing a trove of useful and quirky information about the food you eat. It contains data on about 20,000 products, though you still may not find your favorite junk foods. Most of the products in the database are described as “natural” and “organic.” But if you shop at Whole Foods, you’re in luck. Sage has partnered with Whole Foods Market, deconstructing all of the roughly 7,000 items sold in the grocer’s new “365” store chains in Los Angeles and Lake Oswego, Ore.

To begin using Sage, which is available online or as a web-based app, a user signs up and enters any food restrictions and personal preferences. Only want to see products without additives and preservatives? No problem. Interested in digestive health? Sage will comb through its database and show you products with probiotics, high fiber and whole grains.

The app displays a wide variety of information using colorful graphics and animated food characters, and it’s surprisingly fun and entertaining to use. The app told me that Surf Sweet gummy bears, for instance, do have a fair amount of added sugar but also have “good nutrient density,” meaning that, among other things, they supply a high amount of vitamin C (much to my delight). A jump-roping chocolate bar informs me that I’d need to jump rope for 19 minutes — or a snorkeling olive recommends 23 minutes of swimming — to burn off a serving of Justin’s Organic milk chocolate peanut butter cups.

“Customers want a better understanding of how a product is sourced, the quality standards behind it, whether the labor that made it was paid a fair wage, its impact on the environment,” said Jason Buechel, the chief information officer at Whole Foods. “This is a way to give them all that information that isn’t captured on the nutrition label.”

Take the Beast Burger, for instance, a meatless burger sold at Whole Foods. Type the name of the burger into Sage or flip through a list, and you’ll find its basic nutritional profile and calorie content, with highlights of its nutritional strengths.

Using animated food characters — a pear doing yoga, a watermelon riding a bike — the app shows how much exercise would be required to work off the burger. In my case, it’s 20 minutes of running, 22 minutes of jumping rope, 28 minutes of swimming or biking, 44 minutes of dance or 89 minutes of yoga.

Sage also identifies any allergens — corn and seeds in the case of the Beast Burger — and offers detailed explanations of all the burger’s ingredients, and why they’re used should you be interested. For instance: “Calcium chloride, a salt, is used in canned goods to improve stability and quality and as a firming agent in tofu production.”

The system awards “badges” to the burger for things like an abundance of healthy fats and protein and having recyclable packaging, and it explains what diets — dairy free, gluten free, vegan, vegetarian and ketogenic — it does not violate. To make nutrition recommendations like “fiber friendly” or “heart healthy,” Sage uses nutritional standards set by the Food and Drug Administration and the American Heart Association. An in-house team of dietitians and nutritionists have created standards for badges like “healthy fats” or “contains probiotics” — areas where the F.D.A. doesn’t set guidelines.

Finally, the app tells you where the product is made or sourced. The Beast Burger is American made. If you decided to check out Driscoll strawberries, you might learn your batch came from Mexico.

It also can tailor daily nutritional requirements to a user’s specific weight, height and lifestyle. For instance, Sage came up with a recommended daily caloric intake of about 3,300 calories that is rich in protein for Mr. Slover, given his height, weight and exercise routine — he’s a triathlete. It recommended a 1,600-calorie diet with a lower portion of protein for his mother.

“All those things on a label telling you that a product gives you, say, 10 percent of the daily requirement of protein is based on a default, 2,000-calorie-day diet, a kind of one-size-fits-all approach that doesn’t work,” Mr. Slover said.

One thing the Sage app won’t tell you is what you should or shouldn’t eat. You will have to figure that out for yourself. “I’m not a big fan of red, yellow and green scoring mechanisms for food,” Mr. Slover said. “I don’t think they’re well received by consumers or used very much.”