Wednesday, December 28, 2011

Google changes their Base Data API and now has a new Shopping API

Well the attack at advertisers on Google is ramping up. Today, Google announced the Base Data API is now changing to the Shopping API. This echoes sentiments heard early on from Google that they intended the future of sales to be done through their shopping portal instead of individual websites. One side says they still forward the order to the appropriate web store the link came from (under Shopping, in Google), one side says they are making an attempt to compete directly with Amazon.

 

So for years you have companies and individuals giving Google data to be listed. That equates to letting them use you to build their database, and people wonder why it is so hard to compete on the net. If you take some time to read their policy and search for “banned” products you will probably find large companies that are still listed, yet every new customer that comes out the gate strong using adwords gets struck down by their “Do No Evil” staff. Maybe I can use this as a Moses reference, and that staff turns to a snake and then we change the term “spider” to snake. So you could say “my site just got snaked…..

 

Without further adieu, here is the new posting, located here

“We will periodically check your products to ensure the accuracy of your product data. If your product data doesn’t meet our quality standards, your products will be suspended from Google Product Search until the issues have been addressed.

In case of repeated violations of our quality standards, your items will be suspended:

  • for at least one week after the second violation
  • at least one month after the third violation

After the third violation, we may suspend your items for an extended period of time - potentially indefinitely.”

Then again in their listing of Anabolic Steroids, they leave it so open ended that just about anything can get pulled at ANYTIME:

 

“Anabolic steroids The promotion of anabolic steroids, muscle-enhancing stacks and cycles, body-building supplements that have a similar effect to steroids, and related content, irrespective of claims of legality, are not allowed. Prohibited items include, but aren't limited to:

  • Anabol
  • CellMass
  • Clenbuterol
  • Dianabol
  • Extreme Mass 3.5lbs by SciFit
  • Finakits
  • H-T Dianabol
  • L-Glutamine
  • Mesterolone
  • Nitrix
  • Novedex XT
  • TZ 3 Stack by SciFit
  • Vasospan”

 

So this makes me wonder is arginine is next, or maybe vitamin K? Who knows, but like I have always said, this is OUR fault. WE let Google become as big as they are. Getting them to loosen up is going to be costly and time consuming.

 

 

 

Thursday, December 22, 2011

Changes on the way for Postal customers

Many people trust the postal service as old reliable. Their motto (unofficially) Neither snow nor rain nor heat nor gloom of night stays these couriers from the swift completion of their appointed rounds" usually meant that mail would be delivered. Period.

Now that the government agency has grown clunky and inefficient, lawmakers are proposing some serious changes to the way mail is handled. Right now, they are planning on slowing next day priority mail down to 3-4 days, but when we dig a little deeper, we see that this will not only affect USPS, but FedEx as well.

FedEx has provided next day mail services for USPS to the tune of $1.37 Billion making them the largest outsourced contractor and for FedEx to be able to handle that amount of volume they had to buy more aircraft, trucks and employees (overhead). Couple this with FedEx’s SmartPost delivery option (FedEx pick up, dump in USPS chain for final delivery) and you could see either substantial growth or losses for FedEx. If the quality of the service declines (USPS), more people will look to companies like UPS and FedEx for their next day capabilities. At this point, UPS has the advantage with more next day delivery areas based on hub locations than does FedEx.

With the advent of the internet and email, mail has fallen, Michael Clark from the USPS states “Since 2006, total mail volume has fallen by about 45 billion pieces per year or almost 21 percent,” he said. “In first-class mail, the volume has declined even more significantly. After a first-class mail peak in 2001 of 104 billion pieces, it has fallen 29 percent, or 30 billion less pieces at this point in time.”

A deficit in any business of 21% is not good, and they claim that they had a total deficit of $10 Billion (if you include pensions they did not fund) and that the savings of closing approx 3700 post offices will only generate a savings of only $2.1 Billion. These post offices are in small towns and even though they have not released the complete list, he claims it will not affect employment since they still have to deliver to every area.

So what does this mean to the drop shipper? It means you better buddy up with one of the private carriers now, because if the post office raises rates the private carriers will as well because the lowest standard is set by the government agencies. What you can do is leverage your current shipping with USPS to negotiate a better UPS or Fed Ex rate. For volume, you are looking at probably less than $1.50 extra by using UPS, but you get tracking, and insurance that if the product is not delivered or if it arrives damaged the claims process with UPS alone makes up for that $1.25.

In case I don’t get a chance, Merry Christmas everyone, and make sure you watch “It’s a Wonderful Life”, one of my favorites.

  

Postal Service Progresses With Operational Efficiencies

Proposal to Change Service Standards Filed with PRC

December 05, 2011 

Release No. 11-132 

  From http://about.usps.com/news/national-releases/2011/pr11_132.htm

 Download PDF


WASHINGTON — The U.S. Postal Service today announced it will move forward with its proposal to change service standards. This action is being taken in response to on-going financial challenges caused by the dramatic and continual decline in First-Class Mail volume and the resulting revenue loss.

“The U.S. Postal Service must reduce its operating costs by $20 billion by 2015 in order to return to profitability,” said David Williams, vice president, Network Operations. “The proposed changes to service standards will allow for significant consolidation of the postal network in terms of facilities, processing equipment, vehicles and employee workforce and will generate projected net annual savings of approximately $2.1 billion.” This is part of the overall savings expected from the network optimization initiative, which is projected to save up to $3 billion by 2015.

The size of the existing Postal Service network is dictated by the current overnight transit time in existing service standards. The Postal Service is proposing, through the rulemaking process, to move First-Class Mail to a 2-3 day standard for contiguous U.S. destinations; however, there would be an opportunity for mailers who properly prepare and enter mail at the destination processing facility prior to the day's critical entry time to have their mail delivered the following delivery day.

On Sep. 15, the Postal Service announced it would begin studying 252 out of 487 mail processing facilities for possible closure. At that time, the Postal Service also announced it would be considering changes to service standards in an Advance Notice of Proposed Rulemaking published in the Federal Register. The Advance Notice filing was a formal effort to gather input from the public early in the process to ensure their views can be factored into the service change proposal.

The Postal Service will send to the Postal Regulatory Commission (PRC) a request for an advisory opinion regarding service standard changes associated with a significant rationalization of its mail processing network. Shortly thereafter, the Postal Service will publish a notice in the Federal Register soliciting public comment on the specific proposed changes.

The Postal Service receives no tax dollars for operating expenses and relies on the sale of postage, products and services to fund its operations.

 

 

 

 

 

 

 

 

 

 

Wednesday, December 21, 2011

All American Pharm claims that SciFit does not have proper use of patented ingredients

FOR IMMEDIATE RELEASE Billings, Montana, December 21, 2011
Kre-Alkalyn® Alert
Sci-Fit Kre-Alkalyn® Products are Counterfeit
_____________________________________________________________________ All American Pharmaceutical has just become aware that ATF Fitness Products, Inc. is selling a product labeled "Sci-Fit Kre-Alkalyn®” that is counterfeit. These products have been tested and found to contain none to traces of Kre-Alkalyn®, but instead contain creatine monohydrate. The Sci-Fit Kre-Alkalyn® product does not provide the beneficial results of using the patented Kre-Alkalyn® product. Products identified in this fraud thus far are Sci-Fit Kre-Alklayn® 1500 capsules and Sci-Fit Kre-Alkalyn® 1500 Powder. Consumers can be confident that they are purchasing an unadulterated Kre-Alkalyn® product by purchasing capsules having a printed and color-coded capsule as displayed below. Official Purple Kre-Alkalyn® Capsule Guide:
This alert relates ONLY to the Sci-Fit brand of Kre-Alkalyn® products. Office of All American Pharmaceutical Information & Public Affairs All American Pharmaceutical & Natural Foods Corporation 2376 Main Street, Billings, MT 59105 USA 406-245-5793 www.allamericanpharmaceutical.com www.getkre-alkalyn.com www.krecelazine.com
The foregoing may contain “forward-looking statements” for purposes which are based on management’s current information and beliefs as well as on a number of assumptions concerning future events made by management within the meaning of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding All American Pharmaceutical and Natural Foods Corporation’s (“AAP”) positioning and potential plans, products, partners and partner products, and customer acceptance of products. The forward-looking statements in this press release are only predictions and are subject to a number of risks and uncertainties, which could cause actual results to differ materially. AAP assumes no obligation to update the forward-looking statements contained in this press release. Furthermore, no statements made by AAP in this press release, or information contained herein, may be deemed to constitute either an amendment of an existing agreement or an implied new commitment, promise, or legal obligation by AAP to develop or deliver any specific product, feature, or functionality. The development, release, and timing of any product, feature, or functionality described herein remains at AAP’s sole discretion.
And they also let this out: All American® Pharmaceutical 2376 Main Street Billings, Montana USA 59105
FOR IMMEDIATE RELEASE Billings, Montana, December 13, 2011
ATF/Sci-Fit License Agreements Cancelled
All American® Pharmaceutical has served ATF/Sci-Fit with a Notice Of Cancellation for its license agreements for Kre-Alkalyn®, KarboLyn®, ProtaLyn®, and Gluta-Lyn®.
This Notice Of Cancellation means ATF/Sci-Fit will no longer be able to: 1) purchase these ingredients/capsules, or 2) market and sell products with these ingredients/capsules in them.
The Notice Of Cancellation was officially served to ATF/Sci-Fit on 12-12-11.
Additional information will be released as continued investigations take place.
All American® Pharmaceutical & Natural Foods Corporation 2376 Main Street, Billings, MT 59105 USA 406-245-5793 www.allamericanpharmaceutical.com www.getkre-alkalyn.com www.krecelazine.com
The foregoing may contain “forward-looking statements” for purposes which are based on management’s current information and beliefs as well as on a number of assumptions concerning future events made by management within the meaning of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding All American Pharmaceutical and Natural Foods Corporation’s (“AAP”) positioning and potential plans, products, partners and partner products, and customer acceptance of products. The forward-looking statements in this press release are only predictions and are subject to a number of risks and uncertainties, which could cause actual results to differ materially. AAP assumes no obligation to update the forward-looking statements contained in this press release. Furthermore, no statements made by AAP in this press release, or information contained herein, may be deemed to constitute either an amendment of an existing agreement or an implied new commitment, promise, or legal obligation by AAP to develop or deliver any specific product, feature, or functionality. The development, release, and timing of any product, feature, or functionality described herein remains at AAP’s sole discretion.

Friday, December 16, 2011

SEO is Both Scence and Art- A reprint

Enjoy this for some good weekend reading. A great article by Mark.

http://www.linkedin.com/news?actionBar=&articleID=960045555&ids=0NcP0Udj8MdzAIdjkRdjgMc3oVb3kPdPkRcP4SeiMNdPgMczgMdzAIcPoPe3oVe3gV&aag=true&freq=weekly&trk=eml-tod2-b-ttl-3&ut=24FooNcDu2HB01

SEO is Both Science and Art

Mark Jackson, December 5, 2011 36 Comments

For many people who aren’t involved in search engine optimization (SEO) on a regular basis, it’s easy (or so they think). You simply create a website, write some content, and then get links from as many sources as you can.

Perhaps that works. Sometimes.

More often than not, the craft of SEO is truly a unique practice. It’s is often misunderstood and can be painfully difficult to staff for. Here’s why.

SEO is Science

By definition, “Science” is:

  1. a branch of knowledge or study dealing with a body of facts or truths systematically arranged and showing the operation of general laws: the mathematical sciences.
  2. systematic knowledge of the physical or material world gained through observation and experimentation.
  3. any of the branches of natural or physical science.
  4. systematized knowledge in general.
  5. knowledge, as of facts or principles; knowledge gained by systematic study.

Anyone who has performed professional SEO services for any length of time will tell you that at any given time we have definitely practiced each of the above. In some cases, changes in our industry are so rapid that we crowdsource the science experiments among peers (via WebmasterWorld forums or Search Engine Watch forums).

Unfortunately, Google doesn’t provide step-by-step instruction for optimization of every single website. Every website is unique. Every optimization process/project is unique.

Every website represents new and interesting optimization challenges. All require at least some experimentation. Most SEOs follow strict methods of testing/monitoring/measuring so that we know what works and what doesn’t.

We have a few guidelines along the way:

  • Our “branch of knowledge” is well formed in what Google provides in their Webmaster Guidelines and SEO Starter Guide
  • Our unique experience. Just like you might “learn” marketing by getting your bachelor’s degree in marketing, you really aren’t very good at it until you’ve worked in your field and gained real-world experience. There are so many things that you can read in the blogosphere regarding SEO that are complete crap. But, if you didn’t know any better, you’d buy off on it because “it sounds reasonable, so it must be true!” So, be careful to claim something is 100 percent “true” unless you have enough “scientific” evidence to back up the claim. Otherwise, it’s called “hypothesis”: 
    1. A supposition or proposed explanation made on the basis of limited evidence as a starting point for further investigation. 
    2. A proposition made as a basis for reasoning, without any assumption of its truth.

SEO is Also Art

By definition, art is:

the conscious use of skill and creative imagination especially in the production of aesthetic objects

I've worked with and befriended many incredibly bright SEOs in my years in this business. It is those who manage to blend the scientific skills with the creative thoughts on how to experiment/improve programs are the gems.

Getting creative with SEO is thinking of how a marketing program can encompass social, graphic design, link building, content generation, and PR to drive toward a common goal.

Getting creative with SEO is also about reworking a website’s design/code so that usability and accessibility improve, while maintaining brand guidelines and keeping with “look and feel” requirements, yet improving SEO.

Every day, we must get creative in determining how to best target keywords by determining which method of content generation gives us the best chance at gaining a presence in the search engines and – most importantly – engaging our audience.

Should we write a blog post? Should this be best handled in a press release? How about a video? Infographic? New “corporate” page on the site? There are a multitude of ways that we might determine to target a keyword via content.

The Perfect SEO

Today’s SEO is so much more involved than SEO of years past. When I hear people saying that they’re trying to determine if they should hire an in-house SEO or an agency, I will give them the pros and cons of each (and there sincerely are pros and cons of each).

But one factor which I believe leans toward the strength of an agency is that there’s typically going to be a team of individuals, each with a unique skill set. And, these individuals can share examples of what works and what doesn’t, with each other (scientific experiments often occur), they can bounce creative thoughts off of one another and collectively provide more value than any one person might.

Our industry needs more of these highly-skilled “freaks of nature” who blend both the scienctific skills and artistic creativity of SEO.

 

 

 

 

 

 

Friday, December 09, 2011

Top ideas to get your Nutrition/Supplement website off the ground

Every day I am bombarded with questions on not only how to make a website, but how to make a website GREAT. This is tough to do in the current market, because places like GoDaddy, Network Solutions and others have made it easy, a little too easy for the average Joe Schmoe to make a website, and a poor one at that.  The people that do this are 90% fully employed at another job besides making the website grow, and they wonder why, after a year or so their website has died making them end up pulling the plug. But what happens in that year and a half is what ruins the business.

 

Say you buy a domain, use a pretty WYSIWYG template and built in shopping cart, load it with a few products and sit back and wait for people to flock to your site. During this time if they don’t know what SEO is, they may stumble on a few articles that tell them they need a Google Analytics account and Ad Words/Ad Sense account.  They learn enough just to be deadly, and what I mean by that is they are adept enough that they take away a few sales from bigger, more established websites (people in the business for a long time, have a vested interest in the website, use it as their primary income etc) ruining the market because they feel free to drop prices so low that they make 1-5%. So on an average order of $65, after shipping they may net $1.95. Whoopee! They hit it big time!

 

So now, website A sees what website B is doing and does the same thing, thinking that only “price” is the main competing point, not copy or well written original content, just a few lucky keywords that landed them a few customers that now come back as repeats. This goes back and forth for about a year until website A sees that with the influx of costs associated with SEO, their low prices aren’t enough to keep them in business.  Remember, they work all day so when they get home they may have a few hours to work on the website. It reminds me of dreams of hitting the lottery, if I build it, they will come.

 

So website B sees the same thing and now goes back to the distributor and asks for a bigger discount to compete, using tactics like “if I am not selling anything, you are not making any money”. There are a few out there in wholesale world that buy into this way of thinking, and they drop their drawers expecting the lower cost, lower profit to have higher volume.

 

But remember, since the owner of the website is not spending 100% of his time optimizing his site, he just lowers costs to get more customers, and then website B does the same thing again and so on. So now we have effectively ruined the wholesale pricing of the products so that neither distributor makes money and they go looking for other manufacturers “willing to work with them” and the cycle continues. Once wholesale is ruined, retail is not far behind.

 

But the big boys on the block understand that volume does speak, and since they work the website DAILY, they get the most stage presence. This enables them to now bypass the distributor and go right to the manufacturer. And instead of the manufacturer saying “no, we only support sales of our products through distributors xyz”, they take the money and send product at an even lower price, enabling the big boys on the block to keep prices low and keep a barrier to entry for anyone else trying to get into the game.

 

So how do we fix it? MAP is one way, the other is to not sell direct from manufacturer to anyone except wholesalers. There is where the battle should lie, the distributor that treats the customer the best, give the most attentive service wins hands down every time over price. Maybe not at first, but if there is a shitty distributor out there that like to blue ball the industry by selling so low they only make 5%, eventually the cash will dry up and they won’t be able to buy from manufacturers any longer, sending the websites and store owners back to the better, and a bit more expensive distributor that puts money back into the business and can support large buy ins for extra overhead.

 

No one wins in a price war except the consumer. If you expect to be in business for a long time, you should be able to keep customers by keeping them happy, informed and fairly priced

 

So here are a few tips for new supplement website owners out there to take into consideration. There is enough market share for everyone to play nicely, share the wealth and keep the consumers happy. Here is what I sent a new customer recently; I have removed pertinent info to keep them anon.

 

1.       The rotating banner should be products for sale, as they are negotiating tools you can use with manufacturers when working rebates. Front page space is prime $$$ territory.

2.       All your meta data is great if you want to be only found locally. Remember, this is WORLD WIDE WEB

meta http-equiv="Content-Type" content="text/html; charset=utf-8" />

<meta name="description" content="xxx Nutrition, California- xxxxxxx supports nutrition and fitness franchises, Smoothie Franchise for all customers and body builders.  It provides weight loss pills which helps for diet and build muscles in xxx xxx xxx." />

<meta name="keywords" content="xxx Nutrition, Smoothie Franchise, Bodybuilding Supplements xxxx, Fitness Franchise xxx,  Best

 

3.       Your title tags need changing, they don’t accurately tell the spider what the page truly is

<title> xo Nutrition| Bodybuilding Supplements xxx, CA |Smoothie Franchise |Fitness Franchise xxx| Best Weight Loss Pills </title>

 

4.       View the source code of xxx.com, see how their analytics are high up and look at their meta data and key words. There is a reason they rank well.

5.       Make sure the pages you are indexing with Google have proper meta data and title tags. When someone is typing in a general category, that’s what you want the home page to represent. If someone is searching a brand, make sure your brand home pages have proper meta data and tags. When someone is searching for a particular item, make sure that page is properly tagged and titled so that its relevancy to the search is higher. This is what we call organic SEO.

6.       Rotate your key words/ad words with what you have on sale

7.       Purchase some pay per click PPC advertising to get you on the front page of some results until organic SEO kicks in.

8.       The product selection on the home page is incomplete, and it looks incomplete and frankly, a little amateur.. I would have featured brand, then featured products, with areas for hot products and sale items.

9.       Make the newsletter sign up (raffle) higher on the page. Also, you need to print original copy (blog, reviews) so that when people give you information (leads) you give them something back.

10.   Tie in your lead generation with a newsletter and blog. Every time you send a sales request to a customer (sale ad, coupon etc) you should also be providing original content. This keeps them on site longer, leading to more sales.

11.   Have social media tie ins visible and opened in a new window. You don’t want to redirect someone from your site, you just want them to partake in the call to action.

12.   Invest time and money into getting some t shirts or shaker cups with your logo on them. Key chains and magnets are also cheap ideas that when properly used put your business in front of a buyers face (refrigerator, filing cabinet etc)

13.   They say 1 in 7 people will buy, and if we go off the average order of $65 and profit of $1.95,

1

In 7

=$1.95

10

In 70

=$19.50

100

In 700

=$195 profit

 

You can see what your traffic needs to be like to make enough money to make a living. This does not include possible rebates manufacturers are willing to give you based on volume of sales and visibility.

 

Just my $0.02

 

 

 

Have a great weekend everyone.

 

 



 

 

 

 

 

 

 

 

 

Wednesday, December 07, 2011

HCG News- FDA cracks down on HCG Supplements

 

Didn’t see this one coming? Well, then you haven’t been reading supplementyourlife!

 

Per Google:

hCG
Google AdWords prohibits the promotion of hCG (human chorionic gonadotropin) in relation to weight loss/weight control, or when promoted in conjunction with anabolic steroids.

http://support.google.com/adwordspolicy/bin/static.py?&hl=en&page=guide.cs&guide=1308252&topic=1310883&answer=176031&rd=2

 

FDA NEWS RELEASE

For Immediate Release: December 6, 2011
Media Inquiries: Shelly Burgess 301-796-4651, shelly.burgess@fda.hhs.gov or Tamara Ward 301-796-7567, Tamara.Ward@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA, FTC act to remove “homeopathic” HCG weight loss products from the market
Joint action is first step in halting sale of the products

The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.

Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions.

The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets, and sprays.

The labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction.  Consumers on a very low calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias. 

“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low calorie diet should only be used under proper medical supervision.”

“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”

According to the Warning Letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution. 
Consumers and health care professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm1.
 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm282334.htm for article

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm for warning letters

 

 

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Monday, November 28, 2011

The first shot in the war against our industry

The FDA lobbed a bomb at PA based company SCIFIT affecting the entire line up of products that they manufactured.

 

 

“The FDA today took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.”

 

What this means is that since SCI-Fit did not notify the FDA in ingredient changes as mandated by the new NDI rule, they just came and closed up shop. The NDI or New Dietary Ingredient Notifications required manufacturers to follow a step by step process in determining if any ingredient was made after DSHEA:

Determining Whether a New Dietary Ingredient (NDI) Notification is Necessary

  1. When Is a Dietary Ingredient New?
    1. Is a dietary ingredient that was not marketed in the U.S. before October 15, 1994, a new dietary ingredient (NDI)?
    2. Do I need to submit a NDI notification for a dietary ingredient marketed in the U.S. prior to October 15, 1994?
    3. Is an ingredient that was used to make a conventional food marketed before October 15, 1994, a NDI if the ingredient was not a dietary ingredient marketed in the U.S. before October 15, 1994?
      1. Is a NDI Notification required for a dietary supplement containing a NDI if the supplement contains only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered?
      2. Does the adulteration standard in 21 U.S.C. 342(f)(1)(B) apply to a dietary supplement containing a NDI for which a NDI notification is not required because the supplement contains only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered?
    4. Is a substance that was a component of a conventional food marketed before October 15, 1994, a NDI if the component was not a dietary ingredient marketed in the U.S. before October 15, 1994?
    5. Is a substance that was a component of a dietary supplement marketed before October 15, 1994, a NDI?
    6. What does "marketing" a dietary ingredient mean?
    7. Is a dietary ingredient marketed outside the U.S. prior to October 15, 1994, considered to be a NDI if it was not marketed in the U.S. before that date?
    8. What documentation would I need to show that my dietary ingredient was marketed prior to October 15, 1994?
    9. Is marketing an ingredient for any use prior to October 15, 1994, sufficient to conclude that it is not a NDI?
    10. Is there an authoritative list of dietary ingredients that were marketed prior to October 15, 1994 (a so-called "grandfathered list" or "old dietary ingredient list")?
    11. If I change the manufacturing process for a dietary ingredient that was marketed in the U.S. prior to October 15, 1994, and the changes alter the chemical composition or structure of the ingredient, does that make the ingredient a NDI?
    12. Should I submit a new NDI notification if I change the manufacturing process for a NDI that is the subject of a notification for which I have received an acknowledgment without objection from FDA?

http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/dietarysupplements/ucm257563.htm

 

“This is the first time FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations. The cGMPs for dietary supplements went into effect in 2007, in a stepped process based on company size. This company's compliance date came into effect in 2010, and they did not meet the relevant cGMP requirements after that date”

 

The main reason the FDA is all over stuff like this is because they say it can threaten public health. And since our industry was to chicken shit to regulate itself, Big Brother had to step in and fix things. Now is too late for bargaining, now is too late for pleading, now is a time for action. We need to seriously look at ourselves now and make changes that work with the FDA and not shrub our noses at the FDA like some manufacturers did about ephedra.

 

Learn the rules, and then play by them if you plan on being in business for a long time.