4 ms·

Where is the FDA in all of this? I would hope that after the widespread issues with the product, they would have stepped in and blocked shipment until safety s

Where is the FDA in all of this? I would hope that after the widespread issues with the product, they would have stepped in and blocked shipment until safety studies have been done that comply with regulations.

nimish 10y ago
The supplement industry is big in Utah and Orrin hatch has blocked oversight. The upshot is that supplements are barely regulated if at all. The FDA is very limited in what it can do.
- Caerus 10y ago
  I don't think that applies here. According to the FDA Guidelines [1] (page 4) for a dietary supplement: "Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet" Soylent is clearly marketing it as a meal replacement which should disqualify it as a supplement. 1) https://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf https://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf
  - mikeyouse 10y ago
    It depends how they're structuring everything. They add Omega-3s derived from algae to their product, so that algae is regulated via the supplement standards. The product making people sick appears to be algal flour, which probably falls on the food guidelines. In either case, the essential standard is whether or not it's substantially similar to a product already on the market. The standard is "GRAS" or Generally Recognized As Safe. If you want to sell milk or vitamin C or whatever, you don't need to conduct your own safety studies since both have been sold for years without issue. You just have to ensure that your product is similar enough to the GRAS product to qualify. I actually worked for an Algae Biofuels / Omega-3 company in the Bay Area for a period. The GRAS process wasn't onerous but was actually fairly regimented. We conducted uptake tests and enzyme tests on rats over several different period lengths to ensure that the algal omega-3s we were producing had the same impact as other sources of omega-3. Ours were a slightly different form (Ethyl Esters instead of Triglycerides) so our standard to meet was a little higher. I was on the business side but have an undergrad science background if anyone has any questions. EDIT: Forgot to add a link to the GRAS status of the Algal Flour that Soylent is using: http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm361155.htm http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/No... They did a fair amount of safety testing to determine its status. > In a published 90-day subchronic toxicity study, Hsd:Sprague Dawley rats, (n=10/sex/group) were fed diets of C. protothecoides S106 flour at up to approximately 4,800 mg/kg bw/d for males and 5,400 mg/kg bw/d for females; no adverse effects were observed. In a published 28-day study, Hsd:Sprague Dawley rats, (n=10/sex/group) were fed diets of C. protothecoides S106 flour at up to approximately 7,600 mg/kg bw/d for males and 8,100 mg/kg bw/d for females; no adverse effects were observed. The results of a published bacterial mutation study showed that algal flour (5000 microgram/plate) is neither genotoxic nor mutagenic. Additionally, a published study showed that algal flour did not induce a clastogenic response as evaluated by the bone marrow chromosomal aberration test in mice after a single oral dose (2000 mg/kg bw/d).
mstodd 10y ago
They're busy regulating life saving drugs. If we got rid of the FDA all together, there would be more competition for products like this, and companies would need to win the trust of consumers by providing real health study information.
- binarymax 10y ago
  The argument about drugs is a strawman. Yes there is a 'D' in FDA, but there is also an 'F'. You are also making a false assumption that consumers know what's good for them and what to intake or avoid based on "real health study information" - and this is why the FDA exists in the first place. If there are issues with it performing, that doesn't mean tear it down (that would be a disaster).
- st3v3r 10y ago
  That is quite possibly the most short-sighted response to this topic. Few would read it, and no company would offer any kind of information that is actually conclusive. Expecting the free market to do anything except optimize for profit is silly. And yes, that is profit at the expense of people's health.
- sidlls 10y ago
  Please read about "The Jungle". (Wiki: https://en.m.wikipedia.org/wiki/The_Jungle https://en.m.wikipedia.org/wiki/The_Jungle). Relying on companies to compete on the basis of maximizing customer health is... short-sighted at best.
  - geofft 10y ago
    Right, I was gonna say, didn't we literally try this? And decide that it was a mistake? And come up with the FDA in response?
TazeTSchnitzel 10y ago
Perhaps they're used to dealing with competent proprietors?
wmil 10y ago
There's nothing in soylent that isn't "generally recognised as safe" (GRAS). Some people just have intolerances for some plants. Some common plant products are actually quite dangerous. For instance, grapefruit can interfere with the body breaking down Xanax and Valium. But there's no call for the FDA to stop grapefruit farming.
- rbobby 10y ago
  > grapefruit Try some grapefruit juice and then a coffee... whizzz!! Grapefruit is very weird :)

nimish 10y ago

The supplement industry is big in Utah and Orrin hatch has blocked oversight. The upshot is that supplements are barely regulated if at all. The FDA is very limited in what it can do.

Caerus 10y ago
I don't think that applies here. According to the FDA Guidelines [1] (page 4) for a dietary supplement: "Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet" Soylent is clearly marketing it as a meal replacement which should disqualify it as a supplement. 1) https://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf https://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf
- mikeyouse 10y ago
  It depends how they're structuring everything. They add Omega-3s derived from algae to their product, so that algae is regulated via the supplement standards. The product making people sick appears to be algal flour, which probably falls on the food guidelines. In either case, the essential standard is whether or not it's substantially similar to a product already on the market. The standard is "GRAS" or Generally Recognized As Safe. If you want to sell milk or vitamin C or whatever, you don't need to conduct your own safety studies since both have been sold for years without issue. You just have to ensure that your product is similar enough to the GRAS product to qualify. I actually worked for an Algae Biofuels / Omega-3 company in the Bay Area for a period. The GRAS process wasn't onerous but was actually fairly regimented. We conducted uptake tests and enzyme tests on rats over several different period lengths to ensure that the algal omega-3s we were producing had the same impact as other sources of omega-3. Ours were a slightly different form (Ethyl Esters instead of Triglycerides) so our standard to meet was a little higher. I was on the business side but have an undergrad science background if anyone has any questions. EDIT: Forgot to add a link to the GRAS status of the Algal Flour that Soylent is using: http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm361155.htm http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/No... They did a fair amount of safety testing to determine its status. > In a published 90-day subchronic toxicity study, Hsd:Sprague Dawley rats, (n=10/sex/group) were fed diets of C. protothecoides S106 flour at up to approximately 4,800 mg/kg bw/d for males and 5,400 mg/kg bw/d for females; no adverse effects were observed. In a published 28-day study, Hsd:Sprague Dawley rats, (n=10/sex/group) were fed diets of C. protothecoides S106 flour at up to approximately 7,600 mg/kg bw/d for males and 8,100 mg/kg bw/d for females; no adverse effects were observed. The results of a published bacterial mutation study showed that algal flour (5000 microgram/plate) is neither genotoxic nor mutagenic. Additionally, a published study showed that algal flour did not induce a clastogenic response as evaluated by the bone marrow chromosomal aberration test in mice after a single oral dose (2000 mg/kg bw/d).

mstodd 10y ago

They're busy regulating life saving drugs. If we got rid of the FDA all together, there would be more competition for products like this, and companies would need to win the trust of consumers by providing real health study information.

binarymax 10y ago
The argument about drugs is a strawman. Yes there is a 'D' in FDA, but there is also an 'F'. You are also making a false assumption that consumers know what's good for them and what to intake or avoid based on "real health study information" - and this is why the FDA exists in the first place. If there are issues with it performing, that doesn't mean tear it down (that would be a disaster).
st3v3r 10y ago
That is quite possibly the most short-sighted response to this topic. Few would read it, and no company would offer any kind of information that is actually conclusive. Expecting the free market to do anything except optimize for profit is silly. And yes, that is profit at the expense of people's health.
sidlls 10y ago
Please read about "The Jungle". (Wiki: https://en.m.wikipedia.org/wiki/The_Jungle https://en.m.wikipedia.org/wiki/The_Jungle). Relying on companies to compete on the basis of maximizing customer health is... short-sighted at best.
- geofft 10y ago
  Right, I was gonna say, didn't we literally try this? And decide that it was a mistake? And come up with the FDA in response?

TazeTSchnitzel 10y ago

Perhaps they're used to dealing with competent proprietors?

wmil 10y ago

There's nothing in soylent that isn't "generally recognised as safe" (GRAS). Some people just have intolerances for some plants. Some common plant products are actually quite dangerous. For instance, grapefruit can interfere with the body breaking down Xanax and Valium. But there's no call for the FDA to stop grapefruit farming.

rbobby 10y ago
> grapefruit Try some grapefruit juice and then a coffee... whizzz!! Grapefruit is very weird :)