"FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
(Such as alternative medicines and natural listed vitamins, tablets, capsules, gels, creams, drinks, CBD products)
The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market.
If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness."
Source: FDA Site
Also not regulated by FDA:
(The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.
products included in this definition are soaps and cleansers
(except antibacterial labled soap, that is considered a drug), skin moisturizers, perfumes
, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos
, permanent waves, hair colors, toothpastes
, and deodorants
, as well as any substance intended for use as a component of a cosmetic product.)
Aloe Vera Gel Has No Aloe Vera Example:
"Bloomberg reports that lab tests it recently commissioned showed “no indication” that store-brand aloe gels purchased from Walmart, Target and CVS contained the plant’s juices. A fourth gel from Walgreens tested positive for one of three “markers” that indicate the presence of aloe, but not the other two, the results showed. On their ingredients labels, all the products listed aloe barbadensis leaf juice, Bloomberg reported.
According to Bloomberg, the tests found:
Aloe’s three chemical markers — acemannan, malic acid and glucose — were absent in the tests for Walmart, Target and CVS products conducted by a lab hired by Bloomberg News. The three samples contained a cheaper element called maltodextrin.
The gel that’s sold at another retailer, Walgreens, contained one marker, malic acid, but not the other two. That means the presence of aloe can’t be confirmed or ruled out, said Ken Jones, an independent industry consultant based in Chapala, Mexico. . . .
The four gels that Bloomberg had analyzed were Wal-Mart’s Equate Aloe After Sun Gel with pure aloe vera; Target’s Up & Up Aloe Vera Gel with pure aloe vera; CVS Aftersun Aloe Vera Moisturizing Gel; and Walgreens Alcohol Free Aloe Vera Body Gel."
Where's the FDA regulation?
"Ask Steven Tave, the director of the office of dietary supplement programs at the FDA, why the agency isn't stopping more similar situations
, and he'll give a simple answer: "We're doing the best we can."
In 1994, Congress passed a controversial law called the Dietary Supplement Health and Education Act. Tave said that before DSHEA passed, the FDA was starting to regulate supplements more stringently, the way it does pharmaceutical drugs, but getting "pushback from the industry." The law forced the agency to be more lenient.
(Drugs ARE Regulated by the FDA)
Before a new drug can be sold, the company making it has to apply for FDA approval, and the agency has to conclude that the drug is safe and does what it claims to do.
"So if the drug says, you know, 'used to treat cancer,' then the agency's reviewers are going to look at it and make a determination that there's evidence that it does treat cancer," Tave said.
New supplements don't face any burden of proof. The agency can review products that add new dietary ingredients when it gets a notification, Tave said, but it doesn't "have the authority to stop anything from going to market."
When DSHEA was passed, Tave said, the bill still made sense. In 1994, about 600 supplement companies were producing about 4,000 products for a total revenue of about $4 billion. But that market has since ballooned — today, close to 6,000 companies pump out about 75,000 products.
"We're regulating that with 26 people and a budget of $5 million," Tave said.
Removing a supplement from store shelves comes down to documented emergency-room visits and calls to poison-control centers. Only when a supplement is reported to be unsafe as a result of one of these "adverse events," as the FDA calls them, is the agency compelled to act.
"Most of the time, we don't know a product is on the market until we see something bad about it from an adverse-event report. It's a very different regime from when we know everything is out there and we know what's in it," Tave said, adding: "We don't want to be reactive. We want to be proactive. But we can't be."
Most unsafe supplements have been found to contain ingredients that aren't listed on their labels — usually, these are pharmaceutical drugs, some of which have been banned by the FDA.
A study of product recalls published in 2013 in the Journal of the American Medical Association found that of the 274 supplements recalled by the FDA between 2009 and 2012, all contained banned drugs. A 2014 report found that more than two-thirds of the supplements purchased six months after being recalled still contained banned drugs.
three categories of supplements are the "most lawless of the industry": physical enhancement, weight loss, and sexual performance.
"Some of these companies won't identify ingredients that they purposefully put in the products," she said. "Some weight-loss drugs, for example, that have been pulled from the market — we can still find these in the bottle even though they don't put it on the label."
Tave's 26-person team, the only government employees looking into these issues, didn't even have a dedicated office until about a year and a half ago.
In 2016, the world's largest supplement maker, GNC Holdings Inc., agreed to pay $2.25 million to avoid federal prosecution over allegations that it sold a performance-enhancing supplement that claimed to increase speed, strength, and endurance with an active ingredient called dimethylamylamine, or DMAA. Two soldiers who used the supplement died in 2011, which prompted the Defense Department to remove all products containing DMAA from stores on military bases.
A recent indictment against USPlabs, the Texas-based company that made the supplement, accused it of falsely claiming the product was made of natural plant extracts when it really contained synthetic stimulants made in China.
The problems are ongoing. Earlier this year, the FDA recalled several supplements after they were found to contain unapproved new drugs, and two more were recalled after they were found to contain unlisted anabolic steroids. On August 11, just days before this article was published, the FDA recalled another batch of supplements — this time pills manufactured by a company called PharmaTech — because of possible contamination with bacteria that can cause serious respiratory infection.
"Consumers have no way to know that what's in the label is what's actually in the bottle or box," Austin said. "There are many dubious companies out there that are willing to take a risk with consumers health and their lives."
From Nov. 8, 2017